October 12, 2015

Novan Therapeutics has announced positive phase IIb study results of SB204 for the treatment of acne vulgaris. In the double-blind, vehicle-controlled study conducted across 20 sites in the U.S., 213 subjects were randomized to five treatment arms: SB204 2% twice daily, SB204 4% once daily, SB204 4% twice daily and vehicle once or twice daily and treated for up to 12 weeks. All doses of SB204 showed statistically significant reductions in the percent change of non-inflammatory and inflammatory lesions compared to vehicle at the 12-week endpoint (intent-to-treat population). At the end of treatment, the only dose group to be statistically significant in both absolute change and percent change for both lesion types was the SB204 4% once-daily treatment arm. The absolute change from baseline in inflammatory lesions was -11.3 (42%) for 4% once daily and -5.8 (19%) for vehicle (p=0.004) and the absolute change from baseline in non-inflammatory lesions was -14.1 (37%) for 4% once daily and -7.6 (17%) for vehicle (p=0.032). In a time-to-event analysis, the 4% once-daily treatment demonstrated a time-to-median improvement of 4.1 weeks compared to 11.6 weeks for Vehicle (p=0.014 as defined by a 35% reduction in inflammatory lesions). A 6% difference between the pooled SB204-treated subjects and vehicle-treated subjects was observed in the Investigator Global Assessment (IGA) endpoint. While not statistically significant, the difference in IGA enables the power calculations for future phase III pivotal studies with a 95% confidence interval. At the end of 12 weeks of treatment, <5% of the subjects had a cutaneous tolerability score of “moderate” for any of the local tolerability assessments (erythema, dryness, scaling, itching, burning/stinging) with zero reported subjects having any severe local application site reactions. Based on those results and having completed an end-of-phase II meeting with the FDA, Novan plans to initiate two pivotal phase III trials with SB204 once daily in the first quarter of 2016, targeting enrollment of 1,300 subjects per trial.

March 30, 2015

Galderma Laboratories issued results of a phase III study of adapalene 0.3%/benzoyl peroxide 2.5% (0.3% A/BPO) topical gel compared to Epiduo (adapalene/benzoyl peroxide) Gel (0.1%/2.5%) for acne. The multicenter, randomized, double-blind, parallel-group, vehicle- and active-controlled study enrolled 503 subjects (ages 12 years and older). In the overall population, 0.3% A/BPO demonstrated superior success rate to vehicle (33.7% v. 11%). In addition, superior changes in inflammatory (IN) lesions (-27.0 v. -14.4) and non-inflammatory (NIN) lesion counts (-40.1 v. -18.4) and percent changes in IN lesions (-68.7% v. -39.2%) and NIN lesion counts were observed (-68.3% v. -37.3%, respectively) (all P<0.001). In the severe population, 0.3% A/BPO was superior to vehicle in success rate (31.9% v. 11.8%; P=0.029). In addition, superior changes in IN lesion (-35.1 v. -15.4) and NIN lesion counts (-45.6 v. -17.2), as well as in percent changes in IN lesion (-74.4% v. -33.0%) and NIN lesion counts (-72.0% v. -30.7%, respectively) (all P<0.001 unless otherwise noted).

March 31, 2014

Novan Therapeutics reported results of a phase II study of SB204 for the treatment of acne vulgaris. The phase II study was a double blind, vehicle-controlled, dose-ranging study conducted in 150 subjects with acne. Subjects were randomized evenly to 1% SB204, 4% SB204 or vehicle gel, and treated for 12 weeks. Subjects treated with SB204 recognized a benefit three times faster than the 12-week treatment duration generally needed to see efficacy with a monotherapy. At four weeks, the 4% dose of SB204 demonstrated a statistically significant reduction in both noninflammatory (white heads and black heads) and inflammatory lesions (larger red bumps and pustules) compared to vehicle (p ≤ 0.05, intent-to-treat analysis). Statistically significant reductions also were observed in both the primary and secondary endpoints for lesion types at the 12-week time point.

October 21, 2013

AbbVie reported results of a phase II trial of HUMIRA (adalimumab) for the treatment of patients with moderate-to-severe hidradenitis suppurativa (HS) after 16 weeks of therapy. This post-hoc analysis evaluated HS patients with a baseline AN count of ≥3 and draining fistula count of ≤20 in the three study arms: pbo (n=43), HUMIRA 40mg eow after an initial loading dose (n=45) or HUMIRA 40mg ew after initial loading doses (n=44). Patients were assessed based on several retrospective evaluations including achieving HS-PGAbased (HS-physician-global assessment) clinical response; HiSCR; 50%, 75%, 100% reduction in total AN count (AN50, AN75, AN100) relative to baseline and percent change from baseline in AN count. At week 16, 3.9% (2/51), 9.6% (5/52) and 17.6% (9/51) of patients in the pbo, eow and ew groups, respectively, achieved an HS-PGA of clear, minimal, or mild, with at least a 2-grade improvement relative to baseline (P<0.05 for ew compared to pbo).

June 24, 2013

Foamix has announced results from a phase II trial of Minocycline foam for moderate-to-severe acne. This double-blind, dose-ranging, placebo-controlled study enrolled 150 patients. Patients were randomized into three equal groups of 50 patients who, for 12 weeks, received placebo or one of two Minocycline Foams—1% or 4%. Patients who received a once-daily treatment of Minocycline Foam 4% exhibited an average 71% reduction in inflammatory lesions after six weeks with a respective reduction of 55% in non-inflammatory lesions. The effects were dose-dependent, as demonstrated by the lower effects of the 1% foam and the placebo.

January 21, 2013

XOMA released interim results from a phase II trial of gevokizumab for the treatment of inflammatory facial lesions. This double-blinded, randomized, placebo-controlled study enrolled 92 patients with inflammatory facial lesions due to moderate to severe acne vulgaris. Subjects received gevokizumab 0.2mg/kg or 0.6mg/kg once a month, or placebo, for three months. Data demonstrated the 0.6mg/kg dose group showed a statistically significant reduction of 19 mean inflammatory lesions on Day 42 compared to a reduction of 13 lesions in the placebo treated group (p=0.077). Each of the groups had a mean baseline of approximately 31 inflammatory lesions. The magnitude of the difference was substantially maintained throughout the study, but differences at later measurement points were not statistically significant. The 0.6mg/kg dose group demonstrated both a clinically and statistically significant improvement in the Investigator Global Assessment (IGA) at Day 84, showing a 31% responder rate versus a 5% responder rate in the placebo group (p=0.031). The 0.2mg/kg dose group showed no clinically or statistically significant differences from placebo at any time point in inflammatory lesion count or in IGA. Gevokizumab was well tolerated. The incidence of adverse events was comparable between both active groups and placebo. Based on these data, XOMA will complete the study and then expect to follow non-infectious uveitis into phase III development with its partner, Servier.

March 16, 2009

Isolagen reported positive results from a phase II/III trial of their Isolagen Therapy, an autologous cell transplant system, for the treatment of acne scars. This US-based, multi-center, double-blind, randomized, placebo-controlled study, dubbed IT-A-008, enrolled 109 subjects with moderate to severe acne scars. The subjects received three treatments of Isolagen Therapy on one side of the face or placebo treatment on the other side of the face. The primary endpoints were measured four months following the last study treatment and included: Patient Live Acne Scarring Assessment, a 5- point assessment scale, with a response defined as a 2-point improvement as compared to baseline and Evaluator Live Acne Scar Assessment, a 5-point assessment scale and photoguide, with a response defined as a 1-point improvement as compared to baseline. Both the Patient and Evaluator assessments met the co-primary endpoints and were statistically significant (p-values ≡0.000011 and 0.016, respectively). For the Patient assessments, 43% reported a response to the Isolagen Therapy-treated side of the face, while 18% reported a response on the placebo-treated side of the face. For the Evaluator assessments, evaluators reported that 59% of subjects responded on the Isolagen Therapy-treated side of the face, and that 42% of subjects responded on the placebo-treated side of the face. Safety assessments were under review at this time; however, no serious adverse events were reported.

May 12, 2008

Senetek issued positive results from a phase I trial of Pyratine-6 for the treatment of acne rosacea. This study enrolled 24 subjects with mild-to-moderate acne rosacea. They were evaluated at baseline, four, eight and twelve weeks for physician assessments of inflammatory lesion count, severity of erythema and telangiectasia, transepidermal water loss measurements and overall clinical improvement. Pyratine-6 produced a progressive decrease in the symptoms associated with rosacea including redness and acne lesions. All subject self-assessments showed good tolerability and cosmetic acceptability. After 12 weeks there was overall clinical improvement in 80% of subjects, including reduction of erythema and papules. Transepidermal water loss measurements showed a 22% decrease in water loss, which supports an improvement in skin barrier function. Based on these results, Senetek extended this study to 48 weeks.

March 12, 2007

Collagenex announced positive results from a phase II trial of Metastat for the treatment of acne. This double-blind, placebo-controlled trial enrolled 302 subjects who were divided among four sequential arms. Cohort received placebo, and either a 5 mg, 10 mg or 20 mg Metastat capsule, once a day for 12 weeks. Subjects were then evaluated a baseline and weeks 3, 6, 9, 12 and 16. The primary endpoint of the study was the reduction in inflammatory lesion count at 12 weeks. The secondary endpoint was the change in the Investigator's Global Assessment (IGA) score, a subjective measurement of disease severity. Although some efficacy was observed at the 10 mg dose, statistical significance was reached at the 20 mg dose, with this cohort showing the greatest reduction in inflammatory lesions compared to placebo. At weeks 6, 9 and 12, the reductions in inflammatory lesions for the Metastat group were 36%, 36.1% and 31.7%, respectively, compared to 17.5%, 23.8% and 26.5%, respectively, for the placebo group. When compared to the total placebo group, the reductions in inflammatory lesions in the 20 mg cohort were statistically significant at weeks 6 (p=0.041) and 9 (p=0.037) and less apparent at week 12. The 10 mg Metastat group showed a statistically significant improvement in the IGA scores over placebo at 9 weeks (p=0.022) and the 20 mg group reached statistical significance at 6 weeks (p=0.065) and 9 weeks (p=0.026). Based on the results Collagenex anticipated initiating phase II and III studies in 2007.

February 6, 2006

DUSA Pharmaceuticals has issued results of a phase II trial of their Levulan (aminolevulinic acid) Photodynamic Therapy (PDT), for the treatment of acne. Trial data indicated that the addition of Levulan to vehicle PDT decreased total inflammatory facial lesion count in the subset of patients with the most severe disease (>60 lesions), compared to an increase in lesions for vehicle treatment alone. For all other endpoints the drug did not demonstrate significant superiority to vehicle group, including median decrease in total lesion count (-61% vs. -80%), and percent of subjects achieving at least 2 grades improvement in symptom severity (39% vs. 67%). This investigator blinded study enrolled 72 subjects, who received one of 3 incubation periods with Levulan Kerastick (15, 60 or 120 minute) plus PDT with BLU-U (Blue Light Photodynamic Therapy Illuminator), or BLU-U vehicle PDT alone.

October 31, 2005

Dermik Laboratories issued positive results of a clinical trial of their approved drug BenzaClin (clindamycin 1%/benzoyl peroxide 5%), for the treatment of acne. By week 2, subjects receiving BenzaClin experienced a significant reduction in the number of observed inflammatory lesions, compared to either of the other two treatment arms (p<0.05). At 10 weeks, subjects in Groups one and three (those receiving BenzaClin alone or in combination with other approved therapies) experienced a significant reduction in inflammatory lesion count compared to group 2 (those who received approved drugs other than BenzaClin). More adverse events were noted in Group 3 than either of the other groups. This randomized, evaluator-blind, multi-center trial enrolled 132 acne patients, who received one of three treatment regimens (BenzaClin; tretinoin 0.025% plus clindamycin 1%; or BenzaClin plus tretinoin 0.025% plus clindamycin 1%) for 10 weeks.

September 26, 2005

Barrier Therapeutics issued positive results of a phase IIa trial of their investigational retinoic acid metabolism-blocking agent Rambazole, for the treatment of acne. The drug reduced total lesion count by 50% or more in 94% of subjects (n=16/17), relative to baseline; 35% of subjects (n=6/17) experienced reductions of 90% or greater. The drug was equally efficacious in treating both inflammatory and non-inflammatory lesions, and no serious adverse events were reported. This open-label study enrolled 17 moderate-to-severe acne patients, who received 1 mg oral Rambazole once daily for 12 weeks.

Isotechnika has announced positive interim results of a phase III trial of ISA247 for the treatment of psoriasis. 12-week data met primary efficacy endpoints, with the drug producing improvements on the Psoriasis Area and Severity Index (PASI) scale: 48% of high-dose subjects and 24% of mid-dose subjects achieved a PASI 75 (a reduction in disease severity of 75% or better), and 72% and 47% (respectively) achieved a PASI 50 score (p<0.05 compared to placebo for all values). Mean PASI score reduction was 62.5% for the high dose group and 44.0% for the mid dose group. This randomized, double-blind study enrolled 453 moderate-to-severe psoriasis patients across 32 site in Canada, who received one of three doses of ISA247 (0.2 mg/kg, 0.3 mg/kg or 0.4 mg/kg) or placebo twice daily for 24 weeks.

July 18, 2005

Critical Therapeutics has issued negative results of a phase II trial of Zyflo (zileuton) for the treatment of inflammatory facial acne. Zyflo is currently approved as a treatment for asthma. Results from the study indicated that the drug failed to meet its primary efficacy endpoint: subjects receiving Zyflo experienced a mean reduction in inflammatory lesion count of 11.5 (33.5%), compared to a reduction of 9.5 lesions (26.9%) for placebo, but the difference between these values was not significant (p=0.384). Mean total lesion count, a secondary efficacy measure, showed a positive trend, but also failed to achieve significance (25.3 fewer lesions for Zyflo vs. 16.4 fewer for placebo, p=0.085). A subset of patients with more severe acne yielded some positive results: absolute mean inflammatory lesion count showed a non- significant positive trend compared to placebo (16.2 vs. 11.7; p=0.063), mean inflammatory lesion count decreased significantly (41.6% vs. 26.2%; p=0.025), and trends towards rapid onset of activity were noted at weeks 4 (p=0.078) and 8 (p=0.057). This randomized, double-blind, placebo-controlled study enrolled 101 patients with moderate to severe inflammatory facial acne across 12 US sites. Subjects were randomized to receive zileuton 600 mg (n=52) or placebo (n=49) four times daily for 12 weeks. The company indicated that they were continuing to interpret data from the study, and expected additional guidance in August 2005.

Novogen, through their subsidiary Glycotex, has reported positive results of a phase II study of their investigational would healing compound glucoprime, for the treatment of venous stasis ulcers. Trial data yielded evidence of efficacy, with mean healing rates of 59% for the low dose glucoprime group and 55% for the high dose group, compared to 10% for placebo. This improvement was noted despite the fact that ulcers in the glucoprime group were substantially larger at baseline. Furthermore, ulcers treated with the drug healed 2 mm/day faster than those treated with placebo. This double-blind, placebo-controlled study enrolled 60 patients with chronic deep venous stasis ulcers of the legs across 2 sites in Australia. Subjects received treatment with either low dose (0.1%) or high dose (1.0%) glucoprime gel or placebo thrice weekly for 12 weeks. The company announced plans to initiate additional trials of the drug, in which patients were to be stratified based on wound severity prior to randomization, based on these results.

February 28, 2005

Isolagen announced 12 month follow-up data from a phase III trial of their Isolagen Process, which utilizes autologous fibroblasts to treat facial contour deformities. Study data yielded significant evidence of efficacy, with 57.0%, 79.6%, 77.1%, and 82.2% of patients responding (response was classified as a 2 point improvement on a 7 point standardized photoguide scale) at 1, 2, 4 and 6 months respectively, vs. 38.2% at 6 months for placebo (p<0.0001). Follow-up analysis at 12 months yielded an 82.4% response rate. This double-blind, placebo controlled trial enrolled 151 patients with eight types of facial defects, including acne scarring and rhytids, across 10 US sites. These results were in line with those observed in previously completed European and Australian phase III studies, and supports ongoing US phase III studies being conducted under an SPA with the FDA, with an expected BLA filing date during the second half of 2005.

QLT announced positive results of both a phase III efficacy trial and a long term safety study of their investigational acne medication Aczone (dapsone topical gel) at the Annual Meeting of the American Academy of Dermatology in New Orleans. Results from a phase III safety and efficacy study indicated that the drug produced significant reductions in the incidence of both inflammatory and non-inflammatory lesions and in total lesion count, compared to vehicle gel. Secondary efficacy assessment, using a five point static Physicians Global Assessment Scale, also yielded positive results. Results from a long-term safety study indicated that long-term Aczone treatment was well tolerated, with no increases in adverse events or laboratory abnormalities over time. Plasma drug levels remained consistently low plasma. The multicenter, double-blind, phase III study randomized 496 patients to receive either Aczone (n=330) or vehicle gel (n=166) twice daily for 12 weeks. The multicenter, open-label, non-comparative safety study enrolled 506 patients to receive twice daily topical Aczone application for 12-months; 340 completed the full course of therapy.

August 23, 2004

Xoma reported negative results of their phase II study of XMP.629, their topical investigational treatment for acne. Preliminary data have indicated that the drug offered no significant clinical benefit over a vehicle-gel control treatment, and no discernable dose response among subjects receiving the drug. No safety or tolerability concerns were raised. Xoma did note that the vehicle gel produced a higher-than-expected response. The double blind, randomized, placebo-controlled study, which enrolled 253 subjects, was designed to establish the safety, tolerability, and efficacy profiles of XMP.629 in the treatment of mild-to-moderate acne. Xoma announced that data analysis would continue, but no further studies on the drug were planned.

August 9, 2004

Xoma has reported positive results of two phase I studies of XMP.629, for the treatment of mild to moderate acne. The two trials were designed to profile the cumulative irritation potential and the absorption potential of a 0.1% topical gel formulation of the drug. Results of the irritation study indicated that the drug only rarely irritated the skin, and did not significantly increase irritation over vehicle gel alone, when administered thrice weekly for three weeks. The absorption study indicated that the drug was efficacious in reducing symptoms of acne infection, including erythema and lesions count, was safe and well tolerated, and showed no signs of systemic absorption, when administered daily over 14 days. The two studies enrolled a total of 50 subjects, 35 in the irritation study and 15 in the absorption study. Xoma intends to use these data to support their ongoing efficacy and safety study.

March 29, 2004

Connetics reported positive results from two phase III trials investigating Velac (clindamycin/tretinoin), a topical gel for the treatment of acne vulgaris. Results demonstrated a robust and statistically superior treatment effect for Velac compared to all three comparators on both primary endpoints. The 12-week, double-blinded, placebo- and active-controlled studies enrolled 2,200 subjects with mild-to-moderate acne at 37 sites. The studies were designed to test Velac compared with each of the single active ingredients, clindamycin gel and tretinoin gel, and with the placebo gel. The two primary efficacy endpoints were Lesion Count and Investigator's Static Global Assessment.

December 10, 2001

Preliminary phase II trial results indicate that Micrologix Biotech's MBI 594AN produced a 32% reduction in total acne lesion counts (inflammatory plus non-inflammatory lesions) compared to a 14% reduction for placebo. The randomized, double-blind trial enrolled 75 acne subjects who received twice-daily dosing with either one of two formulations of MBI 594AN (2.5% and 5%) or the product's alcohol-based vehicle alone. Subjects treated with MBI 594AN showed a 39% reduction in inflammatory acne lesion counts compared with 21% for the placebo group. In terms of non-inflammatory acne, MBI 594AN treated subjects experienced a 25% improvement in lesion reduction, compared to 10% for placebo treated subjects.

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