May 30, 2016
Pfizer released results of two phase III studies demonstrating the immunogenicity of TRUMENBA (Meningococcal Group B Vaccine) against invasive meningococcal B (MnB) strains representative of prevalent strains in the U.S. and Europe. One phase III study was a randomized, active-controlled, observer-blinded study that included approximately 3,600 healthy individuals 10 through 18 years of age. Individuals were randomized to receive one of three different lots of TRUMENBA in a zero, two, six-month schedule or a control, licensed hepatitis A (HAV) vaccine, at zero and six months and saline at two months. The hSBA responses one month after doses two and three against the four primary MnB test strains as defined by hSBA responses (titers ≥LLOQ) were 64.0%-99.1% and 87.1%-99.5%, respectively. As these four primary strains are representative, they predict the ability of antibodies elicited by TRUMENBA to be active against diverse circulating strains. The hSBA responses to the 10 additional MnB test strains were 61.1%-100.0% and 75.1%-98.6% one month after dose two and three, respectively. The second phase III study was a randomized, placebo-controlled, observer-blinded study that included approximately 3,300 healthy individuals 18 through 25 years of age. Individuals were randomized to receive TRUMENBA in a zero, two, six-month schedule or a saline control. The hSBA responses one month after dose two and three among TRUMENBA recipients against the four primary MnB test strains as defined by hSBA responses (titers ≥LLOQ) were 68.3%-97.4% and 87.4%-99.4%, respectively. The hSBA responses to the 10 additional MnB test strains were 51.6%-97.9% and 71.3%-99.3% one month after dose two and three, respectively. TRUMENBA is currently approved in the U.S. These data support additional upcoming global regulatory submissions and the planned U.S. supplement to request the conversion of Accelerated Approval to Traditional Approval for TRUMENBA.
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 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.
July 2, 2007
Novagali announced positive results from a phase II/III trial of Vekacia for the treatment of pediatric Vernal Keratoconjunctivitis (VKC). This study was divided in two treatment periods: (I) a four-week prospective, randomized, multicenter, double-masked, three parallel group, vehicle-controlled treatment period and (II) a three-month prospective, multicenter, double-masked treatment period. The trials enrolled 118 pediatric subjects in Europe who received Vekacia 0.05 % and Vekacia 0.1% or placebo, administered four times daily for four weeks. Overall improvement of subjective symptoms was superior to placebo for both concentrations of Vekacia. Objective symptoms showed statistically significant improvements between both concentrations of Vekacia compared to placebo (p=0.0386 and 0.0208 for the Vekacia 0.05% and Vekacia 0.1% treatment arms, respectively). Similarly, improvement in superficial keratitis was statistically significant with Vekacia 0.05% versus placebo (p=0.0176). Treatment was generally well tolerated. Novagali plans to move forward with the development of Vekacia.
May 14, 2007
Ista released positive preliminary results from a phase II/III trial of bepotastine for the treatment of allergic conjunctivitis. This placebo-controlled, randomized, double-blind trial enrolled 90 subjects who received two doses of bepotastine, each dosed once daily and twice daily. The primary endpoint was the efficacy of bepotastine in treating ocular itching and redness. Results demonstrated that both dose concentrations reached statistical significance in the reduction of ocular itching when dosed twice a day, and in one concentration when dosed once a day. In addition, both concentrations and dosing regimens achieved statistical significance in the rapidity of response and the improvement in total nasal symptoms versus placebo. In the second primary endpoint, ocular redness, treatment with bepotastine showed a trend clinical significance but did not achieve statistical significance. Ista plans to complete this trial prior to meeting with the FDA to discuss the remaining clinical requirements for a NDA submission.