Otonomy, a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, announced that the AVERTS-2 phase 3 clinical trial of Otividex in patients with Ménière’s disease achieved its primary efficacy endpoint (p value = 0.029). Otonomy plans to review these results with the US Food and Drug Administration (FDA) and discuss clinical requirements for registration of Otividex for patients with Ménière’s disease. The company expects to provide an update from discussions with the FDA during the first quarter of 2018.
Top-line results for the AVERTS-2 trial are as follows: The clinical trial achieved its primary endpoint of count of definitive vertigo days (DVD) by Poisson Regression analysis in Month 3 for Otividex vs. placebo (p value = 0.029) based on analysis of all 174 patients enrolled in the trial.
The Otividex group demonstrated a 6.2 day reduction in the mean reported number of DVD from baseline to Month 3 with a 2.5 day mean difference between Otividex and placebo in Month 3.
For subjects who completed daily diaries through Month 3 (n=105), there was a 68% reduction in vertigo frequency from baseline to Month 3 in the Otividex group vs. 40% for placebo.
“The success of the AVERTS-2 trial clearly demonstrates the treatment benefit of Otividex in patients with Ménière’s disease, and these results are consistent with our expectations based on the phase 2b trial," said David A. Weber, Ph.D., president and chief executive officer of Otonomy. “We will complete analysis of this trial and prepare for discussions with the FDA which we expect to occur during the first quarter of 2018. We will also further assess the AVERTS-1 trial to identify factors that might explain the different outcome in that trial and inform the design of our clinical program to support an NDA filing."
The AVERTS-2 phase 3 trial was a four month, prospective, randomized, double-blind, placebo-controlled trial of patients with unilateral Ménière’s disease conducted in Europe. Following an initial one month lead-in period, eligible subjects were randomized 1:1 to a single intratympanic injection of Otividex or placebo. Subjects continued in the trial for up to an additional three months of observation. A total of 174 patients were randomized into the study with 105 patients completing daily diaries through three months of post-treatment observation before the trial was terminated on August 31, 2017. Otividex was generally well-tolerated with no drug-related serious adverse events observed.