Otonomy Reports Fourth Quarter and Full Year 2021 Financial – GlobeNewswire
OTO-313 Phase 2 trial in tinnitus fully enrolled ahead of schedule with top-line results expected in mid-2022; initiating safety evaluation of higher and bilateral dosingOTO-413 Phase 2a cohort in hearing loss fully enrolled with top-line results expected early in second quarter of 2022; enrollment ongoing for higher dose evaluationOTO-825 IND-enabling activities ongoing with IND filing expected first half of 2023Current capital funds operations through multiple clinical readouts and into secon…….
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- OTO-313 Phase 2 trial in tinnitus fully enrolled ahead of schedule with top-line results expected in mid-2022; initiating safety evaluation of higher and bilateral dosing
- OTO-413 Phase 2a cohort in hearing loss fully enrolled with top-line results expected early in second quarter of 2022; enrollment ongoing for higher dose evaluation
- OTO-825 IND-enabling activities ongoing with IND filing expected first half of 2023
- Current capital funds operations through multiple clinical readouts and into second half of 2023
Conference call and webcast today at 4:30 p.m. ET
Hosting Investor R&D Event March 22 at 10 a.m. ET
SAN DIEGO, Feb. 28, 2022 (GLOBE NEWSWIRE) — Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today reported financial results for the quarter and year ended December 31, 2021 and provided an update on its product pipeline and corporate activities. The company will host a conference call and webcast today at 4:30 p.m. ET to discuss recent highlights and financial results.
“We are very pleased to have completed enrollment in both the OTO-313 Phase 2 and OTO-413 Phase 2a trials ahead of schedule and look forward to reporting the results from these trials in the coming months,” said David A. Weber, Ph.D., president and CEO of Otonomy. “We also expect to broaden the clinical data informing our next steps for these programs with the ongoing higher dose evaluation for OTO-413 and upcoming higher dose and bilateral dosing safety evaluation for OTO-313. This is an exciting year for Otonomy with multiple clinical trial readouts that will be highlighted during our upcoming Investor R&D Event next month.”
Otonomy Program Updates
- OTO-313: Phase 2 trial in tinnitus is fully enrolled with top-line results expected in mid-2022; initiating safety evaluation of higher and bilateral dosing. Otonomy has completed the enrollment of 153 patients with persistent, unilateral tinnitus of at least moderate severity in a Phase 2 trial of OTO-313 (target enrollment was 140 patients). Patients were randomized 1:1 to a single intratympanic injection of OTO-313 (0.32 mg) or placebo and are being followed for four months. The primary endpoint is the same as reported for the successful Phase 1/2 trial: a responder analysis based on the proportion of patients who report a clinically meaningful improvement in the Tinnitus Functional Index (TFI) from baseline to Months 1 and 2 following treatment. To assess durability of the OTO-313 treatment effect, the follow-up period has been extended out to four months. Top-line results for all timepoints are expected to be available in mid-2022. Additionally, Otonomy is initiating a one-month safety study for bilateral and higher (0.64 mg) dosing of OTO-313 with results expected in the second half of 2022. Together, …….
