April 3, 2017
Glenmark Pharmaceuticals issued results of a phase III trial of GSP 301, an investigational fixed-dose combination of mometasone furoate (25mcg) and olopatadine hydrochloride (665mcg), administered twice-daily as a nasal spray being studied for the treatment of seasonal allergic rhinitis. This U.S.-based trial was a four-arm, double-blind, randomized, parallel group, active and placebo-controlled study that enrolled 1,176 adults and adolescents 12 years of age and older for 14 days of twice daily treatment with GSP 301, mometasone (a corticosteroid), olopatadine (a histamine H1-receptor agonist) or placebo. All trial arms utilized the same vehicle and nasal spray delivery system. The primary endpoint was change from baseline in average morning and evening patient-reported 12-hour reflective Total Nasal Symptom Score (rTNSS). Secondary endpoints include safety and tolerability. In the trial, treatment with GSP 301 demonstrated statistically significant and clinically meaningful improvement from baseline in average morning and evening patient-reported rTNSS, compared to placebo (p<0.001), olopatadine (p=0.028) and mometasone (p=0.019). All investigational treatments administered in the trial were well-tolerated and showed no meaningful differences in reported adverse events (AEs) across study arms. The most common AE occurring in at least 2% of patients was dysgeusia.
March 13, 2017
Aimmune Therapeutics released results of a phase III trial of AR101 for desensitization of subjects with peanut allergy. Of those enrolled, 457 patients (78%) were reactors who experienced dose-limiting symptoms in the DBPCFC at or before the 100mg dose (median=44mg cumulative amount of peanut protein); 116 subjects (20%) were “non-reactors” who consumed all 144mg in the DBPCFC with only mild symptoms or no symptoms at all; 10 subjects (2%) reacted to placebo. Reactors demonstrated higher baseline peanut-specific IgE (psIgE) and Ara h2-specific IgE levels and larger peanut skin prick test (SPT) wheal diameters than non-reactors, and psIgE appeared to provide the greatest utility to discriminate between reactors and non-reactors. The median psIgE in reactors was 70.2 kUA/L, compared with 5.3 kUA/L in non-reactors (a threshold psIgE of 19.25 kUA/L showed the greatest sensitivity and specificity for predicting reactors). Sensitivity to peanut and severity of symptoms during screening DBPCFCs were not closely linked, and neither was associated with baseline immune parameters or age.
May 2, 2016
ALK issued results of a phase III trial of Acarizax for house dust mite (HDM) allergic asthma. The randomized, double-blind, placebo-controlled trial enrolled 834 adult patients. The trial was conducted at 109 sites in 13 European countries and forms part of ALK’s ongoing clinical development program for Acarizax, which has recently been approved in 11 European countries and where it is currently being launched. Patients were treated daily with either a 12 SQ-HDM or a 6 SQ-HDM dose, or with placebo in addition to inhaled corticosteroids (ICS) and short-acting beta-agonists (SABA). After a period of treatment varying between seven and 12 months, daily ICS use was reduced by half for three months and subsequently withdrawn completely for another three months for patients who did not experience an asthma exacerbation. The trial showed that 12 SQ-HDM (the dose approved in the E.U.) significantly reduced the risk of a moderate or severe asthma exacerbation relative to placebo with a hazard ratio (HR) of 0.66, corresponding to a 34% risk reduction. This included a 36% reduction in risk of nocturnal awakening or increase in daily symptoms (HR: 0.64); a 48% reduction in the risk of increased use of SABA treatments (HR: 0.52); and a 42% reduction in the deterioration of lung function (HR: 0.58).
March 14, 2016
Aimmune Therapeutics issued results of a phase II trial of AR101 for peanut allergy. Forty patients completed 12 weeks of post–up-dosing maintenance therapy at a daily dose of 300mg of AR101. Those patients were then administered a double-blind, placebo-controlled food challenge (DBPCFC), in which 100%, 90% and 60% tolerated cumulative amounts of peanut protein of 443 mg, 1,043mg and 2,043mg, respectively (corresponding to 85%, 77% and 51% on an intent-to-treat basis). Patients who passed the highest challenge level demonstrated protection against a challenge equivalent to seven or eight peanuts. ARC002 is the open-label follow-on study to Aimmune’s ARC001 phase II trial. In ARC002, all 26 patients who received placebo in ARC001 crossed over to active treatment. Over a period of approximately 22 weeks, 21 of the 26 patients completed up-dosing to reach a daily dose of 300mg of AR101, at which point they underwent a DBPCFC. Patients then continued on a dose of 300mg of AR101 per day for a further 12 weeks of maintenance before undergoing a final DBPCFC. Also, 21 patients who received active treatment in ARC001 entered ARC002 and continued to receive 300mg of AR101 per day for the additional 12 weeks before the final DBPCFC. Aimmune’s phase III PALISADE trial of AR101 for treatment of peanut allergy is now enrolling patients in the U.S., Canada and nine countries in the European Union.
October 12, 2015
DBV Technologies has announced results
of Viaskin Peanut for peanut allergy. OLFUS
is an ongoing, open-label, follow-up study
to VIPES, the company’s phase IIb clinical
trial with Viaskin Peanut. OLFUS enrolled
171 subjects who previously had received either
placebo or one of three 12-month dose
regimens administered during VIPES. During
the first year of OLFUS, patients were to
receive a daily application of Viaskin Peanut
50μg, Viaskin Peanut 100μg or Viaskin Peanut
250μg for 12 months. Baseline response
levels in OLFUS were based on the results
of the last double-blind, placebo controlled
food challenge (DBPCFC) in VIPES, and adjusted
by the number of patients enrolling
in OLFUS. As in VIPES, a responder in the OLFUS
trial was defined as a subject who could
reach a peanut protein eliciting dose equal
to or greater than 1,000mg peanut protein
during the 12-month DBPCFC or a subject
with a ≥10-fold increase of the eliciting dose
compared to the initial eliciting dose after
12 months of treatment. Patients enrolled
in OLFUS who received placebo in VIPES
were analyzed separately from subjects who
initially received Viaskin Peanut. During the
first 12 months of OLFUS, no drug-related
epinephrine use or serious adverse events
(SAEs) due to Viaskin Peanut were reported.
The study’s median compliance rate, which
was maintained at 96%, also was consistent
with previously reported results. A preliminary
analysis of the OLFUS data showed
that 12 additional months of therapy with
Viaskin Peanut 250μg increased the number
of patients benefiting from treatment to
70% in OLFUS from 50% in VIPES, with 80%
of children (ages 6 to 11 at entry in VIPES)
responding to therapy after 24 months.
Patients who received placebo for one year
in VIPES and received Viaskin Peanut for 12
months in OLFUS showed a 50% response
rate, which was consistent with findings
from VIPES. DBV expects to launch its phase
III Viaskin Peanut trial at 35 sites in North
America, Australia, Ireland and Germany
in the fourth quarter. DBV also is in the
development process for other Viaskin treatments,
such as its treatment currently being
trialed for milk.
June 15, 2015
Aimmune Therapeutics reported results of a phase II study of AR101 for the treatment of peanut allergy. The study, conducted at eight U.S. sites, evaluated 23 patients ages four to 21 who failed a double-blind, placebo-controlled food challenge of less than or equal to 100mg of peanut protein. The randomized, double-blind, placebo-controlled study had 55 patients in the intent-to-treat population, with 29 in the active group and 26 in the placebo group. The active arm had six early discontinuations due to gastrointestinal side effects and compliance issues. All patients who completed the active treatment regimen met the primary endpoint of tolerating a cumulative amount of peanut protein of at least 443mg, compared to five of 26 patients receiving placebo (p≤0.0001). Additionally, 18 of 23 patients who completed the active treatment regimen tolerated a cumulative amount of peanut protein of at least 1,043mg, compared to zero of 26 patients receiving placebo (p≤0.0001). AR101 has been granted Fast Track designation by the FDA. Aimmune Therapeutics plans to initiate a phase III registration trial of AR101 in children and adults.
September 29, 2014
DBV Technologies has reported results
of a phase IIb trial of Viaskin Peanut in peanut
allergic patients. In the double-blind,
placebo-controlled, multicenter trial, 221
patients highly allergic to peanut were randomized
to either a 50μg, 100μg or 250μg peanut
protein dose of Viaskin Peanut versus placebo.
The trial was prospectively organized across
the three dose levels with two patient strata
composed of three different patient age groups:
children (113 subjects ages 6-11) for the first
stratum; and adolescents (73 subjects ages
12-17) plus adults (35 subjects ages 18-55)
for the other stratum. All patients received a
daily application of the Viaskin Peanut patch
over a 12-month treatment period. A total of
56 patients were randomized to the Viaskin
Peanut 250μg dose. In this arm, 50% of
patients responded, compared to 25% in the
placebo group, showing statistical significance
(p=0.0108). Adolescents showed a trend toward
efficacy, showing a response rate of 38.9%
in the active arm v. 22.2% in the corresponding
placebo group. A statistically significant
improvement in the adolescents’ ability to
consume peanut protein also was observed, as
the LS mean in change of CRD versus placebo of
this subgroup was 276mg (p=0.047). The IgG4
increase observed in adolescents, a 3.3 fold increase
over 12 months, suggests the beginning
of a successful desensitization process.
November 18, 2013
Anergis issued results of a phase IIb study
of AllerT for the treatment of birch pollen
allergies. In the placebo-controlled, doubleblind,
multicenter trial, 240 patients from 24
European trial centers were randomized to
receive five pre-seasonal injections of AllerT
50μg, AllerT 100μg or placebo over a period
of two months between November 2012 and
March 2013. Allergen-specific IgG4 antibody
blood levels were similar in all three groups
before treatment. Four weeks after completion
of treatment and prior to the birch
pollen season, the IgG4 levels were similarly
increased in both AllerT dose groups by a factor
of about 20 compared to baseline and to
placebo (p < 0.0001). During the subsequent
birch pollen season, the IgG4 levels remained
similarly elevated in both dose groups, showing
that a plateau of IgG4 had been reached.
By contrast, IgG4 levels remained unchanged
in the placebo group during treatment and
during the pollen season.
June 25, 2012
DBV Technologies reported results from a phase Ib trial of Viaskin Peanut patch for the desensitizing of peanut allergies. This multi-center, randomized, placebo-controlled study enrolled 100 subjects of all ages with peanut allergies—70 non-severe and 30 severe. Subjects received Viaskin Peanut patches with 20μg to 500μg peanut proteins per patch or placebo for two weeks. The patch was safe and well-tolerated by adults, adolescents and children. Expected local cutaneous adverse events (pruritus, erythema, edema or urticaria) at site of patch application seemed to occur more frequently with Viaskin Peanut (86.3%) than with placebo (60%), but this was not statistically significant. Half of the adverse events resolved spontaneously without any treatment in both severe and non-severe subjects. The patch did not trigger any serious adverse events. DBV Technologies has high hopes for Viaskin Peanut in future trials.
March 12, 2012
Circassia reported results from a phase II trial of their ToleroMune T-cell vaccine against ragweed allergy. This randomized, double-blind, placebo-controlled trial enrolled 275 subjects with confirmed ragweed allergy in Canada. The subjects received one of four regimens of ToleroMune treatment over a three-month period. They were exposed to ragweed allergens in a validated exposure chamber and nasal and ocular symptoms were compared against the pre-treatment baseline. The T-cell vaccine's optimal regimen substantially reduced symptoms, achieving a 97% greater reduction than placebo (p≤0.05) in subjects who had a moderate level of symptoms at baseline. The treatment was safe and well tolerated in all groups.
October 3, 2011
Circassia reported results from a phase II trial of their ToleroMune grass pollen vaccine. This randomized, double-blind, placebo-controlled study enrolled 50 subjects with grass pollen allergy who received four doses from one of five different treatment regimes over a 12-week period. Five weeks later skin and eye responses to grass pollen were assessed. The results showed that the vaccine reduced allergic symptoms in the eye by up to 30% more than placebo. The vaccine also improved early and late skin reactions by up to 54% and 19%, respectively, compared to placebo. The safety profile was similar to placebo.
February 7, 2011
Circassia released results from a phase II trial evaluating their ToleroMune T-cell vaccine for cat allergies. This Canadian-based, randomized, double blind study enrolled 202 subjects who received either four or eight standardized doses of ToleroMune treatment, or placebo. They were exposed to aerosolized cat dander in an environmental exposure chamber, both before and after treatment, to measure the effect of the ToleroMune T-cell vaccine. Results showed the ToleroMune vaccine had an immediate and growing treatment effect as allergen exposure increased. The subjects who received four doses of the vaccine over a period of 12 weeks had significantly reduced levels of allergy symptoms when compared with placebo (p≡0.05). These subjects experienced a 55% greater improvement in their symptoms. ToleroMune treatment was well tolerated, with a safety profile similar to placebo.
April 26, 2010
Stallergenes released positive results from a phase III trial of their sublingual grass pollen immunotherapy tablet, Oralair. This U.S.-based randomized, double-blind, placebo-controlled study (VO61.08) enrolled 473 adults with grass pollen-induced rhinoconjunctivitis. The subjects received either placebo or 300IR sublingual tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over the grass pollen season. The primary endpoint a reduction of the Average Combined Score, a combination of the Rhinoconjunctivitis Total Symptom Score and the Rescue Medication Score, compared to placebo. This endpoint was reached with statistical significance. Oralair was well tolerated.
March 8, 2010
Merck issued positive results from a phase III trial evaluating their sublingual grass allergy immunotherapy tablet. This North-American, randomized, placebo-controlled trial enrolled 345 subjects, ages 5-17 years old, with allergic rhinoconjunctivitis caused by pollen from Timothy grass. The subjects received daily treatment with the grass immunotherapy tablet (15mcg of Phl p5, which is a formulation of the timothy grass allergen) or placebo, at least eight weeks prior to and throughout the 2009 grass pollen season. The primary efficacy endpoint was the total combined score, comprised of total daily symptom score and total daily medication score. The allergy immunotherapy tablet showed a 26% greater improvement in the total combined score (daily symptom score and daily medication score), compared to placebo (p≡0.001). Treatment was generally well tolerated and there were no unexpected adverse events.
August 10, 2009
Cytos released positive results from a phase IIb trial of CYT003-QbG10 for the treatment of allergic rhinoconjunctivitis due to house dust mite allergy. This randomized, double-blind, placebo-controlled study enrolled 299 subjects who received six weekly injections of CYT003-QbG10 given at two dose levels (0.5 mg and 1 mg) or placebo. The primary endpoint was efficacy, assessed by recording rhinoconjunctivitis symptom and medication scores in patient diaries over a 14 day period. The higher CYT003-qbG10 dose group was determined to be the most efficacious. In the 1 mg group subjects had a 39% lower median combined symptom and medication score post-treatment than subjects on placebo (p≡0.035). Allergy symptoms were significantly lower in the 1 mg group than in the placebo group (p≡0.027), however medication use was generally low and did not differ significantly between the two groups. The secondary endpoint was change in the quality of life post-treatment. Subjects in the 1 mg group reported a median 42% better quality of life score than patients on placebo (p≡0.020). Treatment at both dose levels was safe and well tolerated.
May 25, 2009
Ista issued positive results from three phase III trials of Bepreve for the treatment of allergic conjunctivitis. The first two studies were 7-week, masked, randomized, placebo-controlled conjunctival allergen challenge (CAC) clinical studies and enrolled a total of 157 subjects who received placebo or Bepreve 1.5% in both eyes. The studies showed Bepreve 1.5% dosed in both eyes was clinically effective in reducing ocular itching associated with allergic conjunctivitis for at least 8 hours after dosing. It was statistically superior to placebo in reducing ocular itching at CAC tests conducted 15 minutes, 8 hours, and 16 hours after dosing (P<0.0001). The third study was a multi-center, double-masked, placebo-controlled design enrolled 86 subjects. The subjects were randomized to receive either Bepreve 1.5% or placebo in both eyes in three CAC tests spaced two weeks apart. The results showed Bepreve 1.5% was statistically superior to placebo for at least 8 hours after ophthalmic dosing for reducing CAC-induced tearing.
May 11, 2009
Stallergenes reported positive results from a phase IIb/III of Oralair Mites, a sublingual vaccine for the treatment of house dust mite allergy. This study, VO 57.07, enrolled 509 subjects with moderate to severe persistent allergic rhinitis to house dust mites, across several international sites. The subjects received a daily intake of either a 300 or 500 IR sublingual tablet or placebo for 12 months. The endpoint was the adjusted average symptom score on nasal symptoms assessed during the three last months of the year. The two treated groups demonstrated a highly significant statistical difference on the primary endpoint versus the placebo group (p<0.0136), with no difference between the two treated groups. In the different groups, use of rescue medication was allowed throughout the period. The adjusted average symptom score was improved by 20% in both treated groups. Specifically, the nasal congestion score was been improved by a median of 40% and the nasal pruritus by a median of 32%. The treatment effect was rapid and maintained throughout the study period.
September 29, 2008
Allergy Therapeutics reported positive data from a phase III trial of Pollinex Quattro for the treatment of ragweed allergy. This double-blind, placebo-controlled study, dubbed R301, enrolled 993 subjects in the US and Canada. The subjects received four injections of either Pollinex Quattro or placebo over three weeks prior to the 2007 ragweed pollen season. The primary endpoint was the difference in combined symptom plus medication score between active and placebo treatment over the four peak pollen weeks of the season. Of the 993 enrolled subjects, 381 received all four injections. The study met its primary endpoint, with Pollinex Quattro Ragweed demonstrating a statistically significant 12% benefit over placebo (p=0.0478). The vaccine was well tolerated. Based on the results, Allergy Therapeutics plans to move forward with the development of Pollinex Quattro.
August 18, 2008
ALK-Abello reported positive results from a phase II/III trial of their sublingual house dust mite allergy vaccine. This randomized, double-blind, placebo-controlled, parallel-assignment study enrolled 604 adolescent and adult subjects in Europe. The subjects were placed in four cohorts, the first three cohorts received the vaccine tablet in various doses and the fourth cohort received placebo. The primary endpoint was to determine whether subjects suffering from allergic asthma caused by house dust mite allergy can reduce their use of conventional asthma medicine in the form of inhaled steroids when treated with the tablet vaccine. The cohort who received the highest dose of the tablet vaccine achieved a 50% reduction (median value) in their use of inhaled steroids compared to baseline. This effect was highly statistically significant compared to placebo (p=0.0036). The tablet vaccine was well tolerated and had a good safety profile. Based on the results ALK-Abello plans to move forward with the development of the vaccine.
May 26, 2008
Allergy Therapeutics released positive results from a phase III trial of Pollinex Quattro for the treatment of seasonal allergic rhino-conjunctivitis caused by grass allergy. This double-blind placebo-controlled study, dubbed G301, enrolled 1,028 subjects in the United States, Canada and Europe. The subjects received four injections of either Pollinex Quattro or placebo treatment over three weeks prior to the 2007 grass pollen season. They then recorded rhino-conjunctivitis symptoms and medication intake over the course of the pollen season from May to September. The primary endpoint was the difference in combined symptom plus medication score between active and placebo treatment over the four peak pollen weeks of the season. The primary endpoint was reached, with a 13.3% improvement in the Pollinex Quattro group over placebo (p = 0.0038) in the Intent To Treat population and a 26.9% improvement over placebo in the prospectively defined patient population (p = 0.0031). Treatment was determined to be safe and well tolerated. Based on the results Allergy Therapeutics plans to file an MAA in the EU in quarter one of 2009.
May 5, 2008
ISTA issued positive preliminary results from a phase III trial of Bepreve for the treatment of allergic conjunctivitis. This multi-center, double-masked, placebo-controlled study enrolled 130 subjects, 117 of whom completed the study. The subjects received two concentrations of Bepreve in two dosing schedules, once-daily and twice-daily. They were evaluated on three separate occasions for response at eight hours and sixteen hours. Both concentrations demonstrated statistically significant reductions in the primary study endpoint of ocular itching. In addition, both concentrations produced statistically significant effects on the rapid response rate and in the secondary endpoints measuring additional signs and symptoms of ocular allergy, as well as improvement in total nasal symptoms. The strongest clinical effect was achieved with twice-daily dosing of either concentration. There were no serious ocular adverse events reported. Based on positive phase III results ISTA plans to file an NDA with the FDA during the second half of 2008.
April 28, 2008
Inspire reported negative results from a phase III trial of epinastine nasal spray for the treatment of seasonal allergic rhinitis (SAR). This fourteen-day, randomized, double-blind trial enrolled seven hundred and ninety eight subjects with documented SAR during mountain cedar season in south central Texas. The subjects received epinastine (0.10% and 0.15%) or placebo. The primary efficacy endpoint was average change from baseline for the reflective Total Nasal Symptom Score (TNSS). The study failed to achieve statistical significance compared to placebo on this endpoint. Based on the results Inspire has decided to discontinue the development of epinastine nasal spray.
September 3, 2007
Cobalis announced additional positive results from two phase III trials of PreHistin for the treatment of ragweed allergy. These parallel, randomized, double-blind trials enrolled 1,551 subjects who received either PreHistin (3.3mg) or placebo twice daily for 42 days. Blood samples were taken from the subjects prior to treatment (before the allergy season) and after treatment and examined for changes in serum ragweed specific Immunoglobulin E (IgE) levels from pre-treatment to post-treatment. PreHistin slowed the expected seasonal rise in IgE when compared to placebo. The average IgE level in the PreHistin arm went from 6.27 kU/mL to 7.68 kU/mL (an increase of 1.41), while the average for the placebo arm went from 6.34 kU/mL to 9.20 kU/mL (an increase of 2.86). Based on positive phase III results Cobalis plans to pursue FDA approval of PreHisitn.
July 16, 2007
Cobalis released mixed results from two phase III trials of PreHistin for the treatment of seasonal allergic rhinitis. These parallel, randomized, double-blind trials enrolled 1,551 subjects in the US. Subjects received either a placebo or a 3.3-mg sublingual dosage of PreHistin twice daily for three weeks prior to the onset of the ragweed allergy season and for an additional three weeks into the allergy season. The primary endpoint was the difference in the mean reduction on the Total Nasal Symptom Score (TNSS) observed between the placebo and PreHistin over the fourth, fifth and sixth weeks of the studies. PreHistin did not achieve statistically significant differences from placebo in this primary endpoint. However, the TNSS data for placebo-treated subjects was far lower than would be expected for this population. The very low symptom levels reported in both the placebo and PreHistin groups were determined to be likely due to low pollen counts in the regions where the trials were conducted. Based on the results, Cobalis plans to pursue FDA approval of PreHistin.
March 19, 2007
Cytos reported positive results from a phase IIa trial of CYT003-QbG10 forthe treatment of grass pollen allergy. This trial enrolled 40 subjects withallergic rhinitis due to grass pollen allergy. Subjects were observed in adouble-blind setting where they received two different formulations ofCYT003-QbG10 monotherapy or placebo and in an open-label setting where theyreceived a CYT003-QbG10 formulation comprising a low dose of grass pollenextract. Efficacy was determined by assessing the allergy status of thesubjects before and after treatment using the conjunctival provocation test,which yields a symptom score ranging from 0 to 15 points. Treatment was welltolerated at all doses tested. CYT003-QbG10 monotherapy led to a significantimprovement of allergy symptoms when compared to placebo (p<0.05) and led to areduction of the median symptom score from 9 points pre-treatment to 5 pointspost-treatment versus 9 points pre-treatment to 8 points post-treatment forplacebo. For the formulation of CYT003-QbG10 plus grass pollen extract, themedian symptom score was reduced from 9 points pre-treatment to 4 pointspost-treatment. Based on the results Cytos plans to move forward with thedevelopment of the drug.
April 3, 2006
Allergy Therapeutics reported positive results of a phase IIb trial, dubbed R204, of their investigational Pollinex Quatro ragweed allergy vaccine. Results from the study met their primary efficacy endpoint, reducing allergy symptom severity by 42% from baseline and by 48% relative to placebo (p<0.01). A highly significant increase in serum IgG levels was noted, indicating strong immunological response (p<0.001). This double-blind, placebo-controlled trial enrolled a per-protocol cohort of 177 patients, who received 4 weekly subcutaneous injections of the drug (n=95) or placebo (n=93). Based on these results, the company announced plans to initiate an end-of-phase-II meeting with the FDA.
January 23, 2006
Dynavax reported positive results of a phase II/III trial of their investigational ragweed allergy immunotherapeutic Tolamba. Data indicated significant efficacy in the trial's primary endpoint, demonstrating a significant reduction in total ragweed allergy nasal symptom score through the second year of the trial following a single-dose of the drug, compared to placebo (p=0.024). Results for a number of secondary endpoints also yielded clinical benefit, including composite hay fever symptoms and ocular effects, and a significant reduction in antihistamine use (p=0.01). Efficacy was not improved in subjects who received "booster" administration of the drug prior to the second year of the study; indeed, this group failed to demonstrate significant benefit vs. placebo in the primary endpoint. This randomized, double-blind, placebo-controlled study enrolled 462 subjects across 29 US sites, who received one of three treatment regimens: a single-dose of Tolamba followed by two Tolamba booster treatments 1 year later; a dose of the drug with two placebo boosters 1 year later; or placebo treatments at both time-points.
November 14, 2005
Dynavax has issued positive results of a phase I trial of Tolamba, for the treatment of ragweed allergy. Study data found the drug to be safe and well tolerated, with no serious adverse events reported and 66% of subjects experiencing no treatment-related adverse events. Immunogenicity data indicated that subjects receiving the drug exhibited greater relative increases in protective IgG antibodies in response to Amb a 1 antigen challenge, while subjects receiving placebo exhibited greater increases in inflammatory IgE response. This double-blind, placebo-controlled study enrolled 24 pediatric patients age 6-17 with mild to moderate ragweed allergy, who were randomized to receive escalating weekly injections of one of three regimens of the drug (escalating from 0.6 mcg to 12 mcg, 0.3 mcg to 21 mcg, or 1.2 mcg to 30 mcg) or placebo for 6 weeks. These data, including the 1.2-30mcg regimen, supported the company's ongoing phase II/III trial of Tolamba in adult patients.
September 26, 2005
Evolutec has issued positive results of a phase II trial of rEV131, their recombinant immunomodulatory drug under investigation for the treatment of seasonal allergic rhinitis. Results from the study met their primary efficacy endpoint, producing a significant reduction in the mean sum of symptom scores at 15 minutes (p<0.05). Symptom relief was seen to be dose-dependent, and no serious adverse events or tolerability concerns were raised. This placebo-controlled, single-dose, dose- ranging allergen-challenge study enrolled 112 patients across 2 sites in San Antonio, Texas, who were randomized into one of four 20-patient single-dose cohorts (16 active, 4 placebo), or a fifth cohort of 32 subjects at the optimum dose (16 active, 16 placebo). Based on these results, the company announced plans to initiate a multiple-dose phase II study of the drug in the near future.
July 25, 2005
Cobalis issued positive preliminary results of a phase III trial of PreHistin, for the prevention of seasonal allergies. PreHistin was seen to be efficacious in reducing the 4 primary symptoms of seasonal allergy (sneezing, runny nose, nasal congestion, and nasal itch). Administration of PreHistin prior to allergy season produced greater symptom relief at the end of the study than pretreatment with placebo, and subjects receiving PreHistin both before and after the start of the season experienced the greatest degree of symptom amelioration. This randomized, double-blind, placebo- controlled parallel-group study enrolled 715 patients across 8 sites in the US. Starting 3 weeks prior to allergy season and continuing for 3 weeks after the start, subjects were randomized to one of 4 treatment regimens (placebo then placebo; placebo then PreHistin; PreHistin then placebo; PreHistin then PreHistin).
April 11, 2005
Rigel Pharmaceuticals announced publication of positive results from a phase II study of R112, their Syk-kinase inhibitor for the treatment of allergic rhinitis, in the Journal of Allergy and Clinical Immunology. Results from the study yielded evidence of efficacy, producing significant improvement vs. placebo on both day 1 (p=0.0005) and day 2 (p=0.0016) in Global Symptom Complex (GSC) score. The drug also produced improvement in all 10 individual allergy symptoms in the GSC scale (p<0.005), and improvement was achieved as early as 30 minutes post-dosing. This double-blind, randomized, placebo-controlled parallel-group trial enrolled 320 rhinitis patients across 2 outdoor US sites, who received either intranasal R112 (n=160) or placebo (n=160) twice daily for 2 days, during pollen allergen challenge.
March 28, 2005
Dynavax Technologies has issued positive results of a single-season phase I trial of their investigational ragweed allergy immunotherapeutic AIC. Trial data met their primary safety endpoints, with no serious local or systemic adverse events and a positive tolerability profile. Significance was observed in key secondary immunologic endpoints, with drug administration producing an increase in both anti-ragweed and anti-Amb a 1 antibody immunoglobulin (Ig) G levels vs. both baseline and placebo (p<0.05), with no significant increase in IgE allergic antibody levels. Drug administration also yielded secondary evidence of efficacy, with a statistically significant decrease in late-phase skin test reaction (p=0.008) and a clinically relevant decrease in symptom intensity (p=0.052), vs. placebo. This single-center, double-blinded, placebo-controlled study enrolled 18 ragweed-allergic patients, and was designed to investigate the safety and tolerability of the drug. Subjects were randomized 2:1 to receive escalating doses of AIC (0.3-30 mcg) or histamine placebo via weekly injection for 7 weeks. The company announced that these data would be used to support their ongoing phase II/III trial of the drug.
ID Biomedical announced positive results of several phase I studies of their Pneumococcal Group-Common Vaccine (PGCvax), under development for the prevention of diseases caused by Streptococcus pneumoniae. Combined results indicated that the drug was safe and well tolerated across multiple age groups, including pediatric patients and the elderly. In addition, significant antibody responses were noted in 92% of young adults and 85% of elderly subjects receiving optimal doses of the vaccine, with 9.0 fold mean increase for both groups (p<0.0001). These safety and immunogenicity trials enrolled toddlers, young adults and elderly subjects, who received one or 2 doses of either the drug or placebo. Based on these results, the company announced that it had received clearance from Canadian regulatory authorities to initiate a Phase 1 study of the drug in 75 infants.
February 28, 2005
Biolipox has reported positive results of a clinical trial of its investigational antihistamine NLA Nasal Spray. Study results yielded evidence of efficacy against histamine challenges, as measured by histamine-associated protein response observed via intranasal lavage. Onset of efficacy was noted within 5-10 minutes of administration. This double-blind, randomized crossover study enrolled 12 healthy volunteers, who received single sequential doses of either NLA Nasal Spray or placebo. The company announced that these results, in combination with positive results of a phase IIa efficacy trial announced in June 2004, strongly supported the continued development of the drug.
January 24, 2005
ALK-Abello has reported positive preliminary results of their “GT-07” trial of their sublingual grass-pollen immunotherapy tablet, for the prevention of rhinoconjunctivitis (hay-fever). Trial data met their primary efficacy endpoint, producing a 37% reduction in symptoms of rhinoconjunctivitis and a 41% reduction in the need for additional medication, vs. placebo. The drug was also found to be safe and well tolerated. This double-blind, placebo-controlled, multi-centre study enrolled 114 patients with moderate-to-severe rhinoconjunctivitis and grass pollen induced mild-to-moderate asthma in Sweden and Denmark. Subjects were randomized to receive either the tablet or placebo once daily for at least 10 weeks.
Genentech has reported positive final results of a phase III extension study of their approved humanized monoclonal antibody Raptiva (efalizumab), for the treatment of moderate to severe plaque psoriasis. Results indicated that the drug produced demonstrated improved efficacy at 24 weeks vs. 12 in a number of clinical outcomes, including improvements in the portion of subjects achieving PASI-75 severity score improvement levels (43.8% vs. 26.6%), PASI-50 (66.6% vs. 58.5%). Furthermore, the percentage of patients who achieved a sPGA rating of minimal or clear increased from 25.7% at 12 weeks to 35.9% at 24, and the mean percentage of improvement in all patient-reported outcomes was maintained at week 24. Overall reported adverse events also declined during the extension (from 80.4% to 63.2%). This 12-week, 516-patient open-label extension followed a 12-week, 556-patient, double-blind, placebo-controlled parallel-group study, which investigated once-weekly subcutaneous dosing of 1 mg/kg Raptiva or placebo.
Valeant Pharmaceuticals has issued positive results of a phase II trial of its oral guanosine analog Viramidine, for the treatment of Hepatitis C. Preliminary analysis of trial data has indicated that the trial met its primary efficacy endpoint, demonstrating non-inferiority of Sustained Viral Response (SVR) for the 600 mg. BID dose of Viramidine, compared with ribavirin (an approved treatment), at both the end of treatment (24 or 48 weeks) and after an additional 24 week follow-up. Furthermore, the drug produced a significantly lower rate of anemia than the approved therapy (4% vs. 27%; p<0.001), and incidence of all other adverse events was similar between drugs. This active-controlled proof of concept study enrolled a total of 180 treatment-naïve patients with chronic HCV, who were randomized to receive one of three BID regimens of Viramidine (400 mg, 600 mg, or 800 mg) or standard therapy with ribavirin (1,000/1,200mg daily). Subjects were treated for 24 or 48 weeks, based on viral genotype analysis, and then enrolled in a 24 week extension study. Based on these results, Valeant has announced plans to use the 600 mg BID regimen of the drug in phase III trials.
September 20, 2004
Cytos Biotechnology issued positive results from their first phase I study of their immunostimulatory drug QbG10, which consist of an antigenic virus-like particle (Qb) coupled to an immunogenic DNA sequence (G10). Results demonstrated that treatment with the drug was safe and well tolerated, with no serious adverse events; the most common minor event was a mild, transient injection site reaction. The study also found the drug to be significantly immunogenic, with high levels of Qb-specific antibodies observed in all evaluable subjects receiving QbG10. Further, Qb-specific T-cells were detected, in a concentration comparable to those observed in a normal antiviral response, in all subjects receiving QbG10 plus Alum, and 73% of subjects receiving QbG10 without Alum. No anti-Qb immune response was observed in the placebo group. This single-center study randomized a total of 35 healthy subjects, who received one of 5 regimens of QbG10 or placebo. Cytos announced plans to initiate a phase II study of QbG10 in the immunological treatment of allergy in late 2004, and a phase I/II study in the immunological treatment of malignant melanoma in the second half of 2005.
August 9, 2004
Rigel Pharmaceuticals has announced positive results of their phase II study of R112, their intranasal investigational drug for the treatment of allergic rhinitis. Results indicated that the drug was immediately efficacious in mitigating rhinitis symptoms, with an improvement in symptom severity of 20% over placebo and 38% over baseline. The drug was also confirmed to be safe and well tolerated, with an adverse events profile statistically indistinguishable from placebo. Furthermore, R112 showed significant improvement over placebo as soon as 30 minutes after administration, and amelioration continued throughout the day long observation period. The randomized, double-blind, placebo-controlled, allergen-challenge study enrolled a total of 319 subjects, all of whom suffered from allergic rhinitis. Rigel announced plans to initiated phase III studies based upon these results.
July 5, 2004
Dynavax Technologies and UCB Pharma have reported positive results of their phase I pediatric trial of AIC, their investigational ragweed allergy vaccine. Results have indicated that the drug is well tolerated in children and adolescents. The dose-escalating, open-label study enrolled 24 children between the ages of 9 and 17, all of whom had documented ragweed allergy; subjects were divided into three dosing cohorts, which each received increasing doses of AIC. Overall safety and tolerability were excellent, with only minor, localized, injection-site reactions reported and no serious adverse incidents. Based on these data, the companies announced plans to extend their clinical investigations into the use of AIC as a prophylactic against ragweed-allergy-induced sequelae, including asthma and chronic sinusitis.
March 29, 2004
Alcon reported results from a phase III trial investigating olopatadine, a nasal formulation of Patanol for the treatment of seasonal allergic rhinitis (SAR). Results showed the nasal formulation significantly reduced SAR symptoms compared with placebo. The multi-center, randomized, double-blind, placebo-controlled study enrolled 677 subjects. Subjects were given olopatadine nasal spray (0.6% or 0.4%) or a placebo spray twice a day for two weeks. A nasal composite score measured a combination of sneezing and stuffy, runny and itchy nose symptoms. The primary objective was the change from baseline in the total nasal symptom score, defined as the average of the morning and evening reflective severity scores for all patients across all days. Results were reported at the annual meeting of the American Academy of Allergy Asthma and Immunology (AAAAI) in San Francisco.
Vicuron Pharmaceuticals reported positive results from a phase III trial investigating anidulafungin, an antifungal in combination with liposomal amphotericin B (LAmB) for the treatment of invasive aspergillosis infections. Results showed that the global response rate ranged from 12 to 49% at the 95% confidence interval. The non-comparative, multi-center, global trial enrolled 30 subjects with invasive aspergillosis. Subjects were administered both LAmB at 3-5 mg per kg daily and anidulafungin intravenously at 100 mg daily, with an initial loading dose of 200 mg of anidulafungin. Treatment was well tolerated with few drug-related serious adverse events.
March 22, 2004
Rigel Pharmaceuticals reported results from a phase I/II trial investigating R112, an immunoglobulin E (IgE) receptor inhibitor for the treatment of allergic rhinitis. Results demonstrated that R112 was well tolerated and showed favorable biological effects. Data showed that subjects treated with R112 tested similarly to the vehicle controls across a wide range of clinical and laboratory safety tests. In addition the study demonstrated a statistically significant decrease in prostaglandin D2 (PGD2), a key immune mediator correlated with improvements in the allergic symptoms of rhinorrhea. The single dose, randomized, double blind, crossover trial enrolled 20 subjects. Subjects received one dose of R112 or vehicle control, given intranasally followed by nasal allergen challenge 15 minutes later. Results will be reported at the annual meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI) in San Francisco. Rigel plans to initiate phase II efficacy trials in Q2, 2004.
May 26, 2003
Inspire Pharmaceuticals reported negative results from a phase III trial investigating INS37217 Intranasal, a P2Y2 agonist for the treatment of perennial allergic rhinitis. Results showed the drug did not meet the primary endpoint of significantly reducing the total nasal symptom score over the 28-day treatment period versus placebo. Subjects receiving INS37217 Intranasal did have a decreased incidence of respiratory-related infection as compared to subjects on placebo. The total nasal symptom score was a composite of four symptoms: rhinorrhea, nasal congestion, nasal itching and post-nasal drip. The randomized, double blind, placebo-controlled study enrolled 630 subjects and was designed to assess the safety and efficacy of INS37217 Intranasal in a 10mg/mL non-preserved nasal spray formulation.
March 17, 2003
Dynavax Technologies, Johns Hopkins University, and the National Institutes of Health reported positive results from a phase II trial investigating AIC, an anti-allergy immunotherapy for the treatment of ragweed allergy. Results indicated the drug reduced allergy symptoms and other clinical markers of allergic response. The study showed that individuals who received AIC therapy prior to the 2001 ragweed season had substantially lower hay fever nasal allergy symptoms and used less allergy medication during the 2002 peak ragweed season, compared to individuals who received placebo. Quality of life scores and daily symptom diaries also indicated fewer allergy symptoms among study participants. The observer-blinded, placebo-controlled study evaluated adult volunteers who had a history of fall seasonal allergic rhinitis and exhibited skin test reactions to ragweed pollen.
September 30, 2002
Interim data from an ongoing phase II dose escalation trial indicates that DX-88 was well tolerated by subjects with acute hereditary angioedema (HAE). The primary endpoint was a favorable response in the relief of HAE symptoms within 4 hours post-dosing. The five subjects received one of two doses of DX-88 (10 and 40 mg) or placebo. 100% of subjects treated with DX-88 tolerated the investigational medication well, with the exception of one subject with a history of allergies. This study was sponsored by Dyax.
August 19, 2002
Inspire Pharmaceuticals announced positive results of a phase II trial with INS37217 Intranasal, a P2Y2 agonist, for the treatment of perennial allergic rhinitis (PAR). The randomized, parallel-group, double-blind study, which involved 59 subjects with chronic rhinitis, compared the effects of three doses of INS37217 Intranasal to placebo. Results showed that subjects treated with INS37217 Intranasal demonstrated statistically significant improvement in PAR symptoms as compared to placebo across multiple days and multiple doses. In addition, the mid-dose treatment group showed statistically significant improvement compared to placebo in the mean total nasal symptom score at the end of the study. This result is consistent with phase I results which also indicated the most robust effects in the mid-dose group.
May 6, 2002
Positive preliminary results were obtained from a phase II trial of TNX-901, an anti-IgE antibody being developed for individuals with peanut allergies. The trial included 84 subjects and evaluated four TNX-901 dose groups (0 mg, 150 mg, 300 mg and 450 mg). Statistical significance was achieved in the primary endpoint, which was based on an increase in symptom threshold to peanuts by oral food challenge. TNX-901 is being developed by Tanox.
January 14, 2002
According to phase III trial results, a fixed-combination tablet containing loratadine and montelukast sodium did not produce a statistically significant improvement in subjects with seasonal allergic rhinitis compared to the separate administration of each drug. Merck and Schering-Plough, who are co-developing the combination tablet, plan to further evaluate these results and possibly conduct additional studies. Loratadine is the active ingredient in Schering-Plough's antihistamine, Claritin, and montelukast sodium is the active ingredient in Merck's leukotriene receptor antagonist, Singulair.