Otonomy Inc. (NASDAQ:OTIC) announced positive phase 1/2 top-line results in the OTO-313 study in patients having moderately severe persistent tinnitus. The company also provided updates on the statistical analysis plan associated with the current third phase OTIVIDEX clinical study in Meniere’s disease.
Positive OTO-313 study results
Exploratory efficacy group in the OTO-313 trial included 31 evaluable subjects randomized to a single OTO-313 intratympanic injection or placebo and tracked for eight weeks. The subjects reported tinnitus symptoms severity through the Tinnitus Functional Index and everyday reporting of their tinnitus annoyance and loudness. The study achieved its objectives by showing positive OTO-313 clinical signal based on the responder analysis of TFI with an acceptable safety profile.
Based on the result, the company plans to advance OTO-313 into second phase development that may include the basement of retreatment with OTO-313. Otonomy’s CEO and President, David Weber, indicated they were delighted to release the positive OTO-313 l study results and advance a possible treatment for individuals with moderately severe persistent tinnitus. Weber added that this is a massive step for the company that expects third-phase 1/2 OTO-413 results in Q4, 2020. Otonomy anticipates OTIVIDEX third phase study results in the treatment of Meniere’s disease in Q1, 2021.
Otonomy updates statistical analysis model for OTIVIDEX
Otonomy offered an update on the OTIVIDEX clinical study regarding questions from the FDA about its use of a Generalized Poisson model in analyzing vertigo count data from subjects. The company submitted a reviewed statistical analysis model using the Negative Binomial model test for the main analysis of the current study. The choice of the Negative Binomial model to address the questions from the FDA gives the best fit for the clinical data from the phase 2b trial and AVERTS-2 phase 3 data.
Weber stated that Otonomy recently completed a review of a statistical analysis model that best fits the clinical data from the OTIVIDEX study. He added that the new model offers an enhanced fit and minimized Type 1 error relative to the Generalized Poisson model.