Otonomy Reports Third Quarter 2021 Financial Results and Provides Corporate Update – Yahoo Finance
OTO-313 Phase 2 trial in tinnitus ongoing with results expected in mid-2022
Enrollment nearly complete in OTO-413 Phase 2a cohort in hearing loss with results moved forward to early in second quarter of 2022
Initiating clinical safety evaluation of higher dosing for OTO-413 to support full dose-ranging Phase 2 efficacy trial expected to start by the end of 2022
OTO-825 IND-enabling activities ongoing with IND filing expected first half of 2023
Conference call and webca…….
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OTO-313 Phase 2 trial in tinnitus ongoing with results expected in mid-2022
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Enrollment nearly complete in OTO-413 Phase 2a cohort in hearing loss with results moved forward to early in second quarter of 2022
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Initiating clinical safety evaluation of higher dosing for OTO-413 to support full dose-ranging Phase 2 efficacy trial expected to start by the end of 2022
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OTO-825 IND-enabling activities ongoing with IND filing expected first half of 2023
Conference call and webcast today at 4:30 p.m. ET
SAN DIEGO, Nov. 10, 2021 (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 ended September 30, 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 have continued the strong momentum in enrollment for the OTO-313 Phase 2 trial in tinnitus with results still expected in mid-2022, and we are ahead of schedule for the OTO-413 Phase 2a cohort with results now expected early in the second quarter of 2022,” said David A. Weber, Ph.D., president and CEO of Otonomy. “Because all OTO-413 doses tested in the initial Phase 1/2 cohorts were well-tolerated, we undertook additional work to support evaluation of higher dosing. We have shared this information with the FDA and are pleased to initiate enrollment of a higher dose cohort in the next month. Results from the Phase 2a cohort and higher dose safety evaluation will support our strategy to identify several OTO-413 doses to evaluate in a full dose-ranging Phase 2 efficacy trial expected to start by the end of 2022.”
Otonomy Program Updates
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OTO-313: Phase 2 trial in tinnitus is ongoing with top-line results expected in mid-2022; results of positive Phase 1/2 trial recently published in leading otolaryngology journal. Otonomy is conducting a Phase 2 trial of OTO-313, based on the design of the successful Phase 1/2 trial, that will enroll approximately 140 patients with persistent, unilateral tinnitus of at least moderate severity. To enrich the study population, this trial is excluding patients with severe or profound hearing loss and has an increased minimum Tinnitus Functional Index (TFI) score required for entry. Otonomy is expanding the patient population eligible for enrollment by increasing the maximum time from tinnitus onset from six months up to one year. The primary endpoint is the same as reported for the Phase 1/2 trial: a responder analysis based on the proportion of patients who report a clinically meaningful improvement in TFI from baseline to …….
Source: https://finance.yahoo.com/news/otonomy-reports-third-quarter-2021-211800397.html
