Otonomy says Phase 3 trial of OTIVIDEX did not meet primary endpoint

Otonomy announced that the Phase 3 clinical trial of OTIVIDEX in patients with Meniere's disease did not achieve the primary endpoint, which was the count of definitive vertigo days in Month 3 for OTIVIDEX vs. placebo for the intent-to-treat population using the Negative Binomial Model. This analysis did achieve statistical significance for the per protocol population. These results were similar using the Generalized Poisson model. "We are disappointed by the top-line results for the primary intent-to-treat population and are undertaking an assessment to understand the difference observed with the per protocol analysis. We thank the many patients, clinical investigators and study site staff who supported this effort," said David Weber, Ph.D., president and CEO of Otonomy. "Our focus turns to the strong pipeline we have built as recently highlighted by the successful clinical trial results for OTO-313 in tinnitus and OTO-413 in hearing loss. OTO-313 and OTO-413 each address a large patient population with significant unmet need and no approved drug therapy. These programs provide an attractive opportunity for the company with clinical readouts anticipated in mid-2022. We expect that our existing cash balance will permit us to achieve these clinical readouts as well as advance our preclinical hearing loss programs including OTO-825, a gene therapy for congenital hearing loss." The company previously reported a cash balance including cash, cash equivalents, and short-term investments totaling $86.3M as of December 31, 2020, GAAP operating expenses for full year 2020 of $42.6M and non-GAAP operating expenses, which exclude stock-based compensation, for full year 2020 of $36.5M.