Otonomy Announces Top-Line Results for the Phase 3 Clinical Trial of OTIVIDEX® in Patients with Ménière's Disease
February 22 2021 - 07:00AM
GlobeNewswire Inc.
*Otonomy shares are trading lower after the comapny announced that its Phase 3 clinical trials of OTIVIDEX in patients with Meniere's disease did not meet its primary endpoint.
Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that the Phase 3 clinical trial of OTIVIDEX in patients with Ménière’s disease did not achieve the primary endpoint, which was the count of definitive vertigo days (DVD) in Month 3 for OTIVIDEX vs. placebo for the intent-to-treat (ITT) population (n = 148; p value = 0.312) using the Negative Binomial Model. This analysis did achieve statistical significance for the per protocol (PP) population (n = 136; p value = 0.031). These results were similar using the Generalized Poisson model (p value = 0.340 for ITT and p value = 0.030 for PP).
“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 A. 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 $86.3 million as of December 31, 2020, GAAP operating expenses for full year 2020 of $42.6 million and non-GAAP operating expenses, which exclude stock-based compensation, for full year 2020 of $36.5 million.
