eClinical Technology and Industy News

Otonomy Initiates Phase 2 Clinical Trial of OTO-313 in Tinnitus

Excerpt from the Press Release:

SAN DIEGO, March 25, 2021 (GLOBE NEWSWIRE) — Otonomy, Inc. (NASDAQ: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced the initiation of a Phase 2 clinical trial of OTO-313 in patients with unilateral tinnitus. The randomized, double-blind, placebo-controlled Phase 2 study will enroll approximately 140 patients with persistent, early onset tinnitus of at least moderate severity. Following the successful Phase 1/2 trial, the primary efficacy endpoint will be a responder analysis based on the proportion of patients reporting a clinically meaningful improvement in TFI from baseline to both Month 1 and Month 2 following treatment. Top-line results are expected in mid-2022.

“Tinnitus is a common problem that negatively impacts millions of people by disrupting their ability to sleep, concentrate at work, and enjoy leisure activities. This often leads to anxiety and depression that can be quite severe, as sadly reported in a recent case of a prominent post-COVID patient experiencing unrelenting tinnitus,” said David A. Weber, Ph.D., president and CEO of Otonomy. “Unfortunately, there are no approved drug treatments for tinnitus and current therapy focuses on coping and masking mechanisms. OTO-313 was designed to address the underlying pathology producing the false perception of sound, with the Phase 1/2 trial demonstrating a clinically meaningful reduction in tinnitus severity in a group of responders. We are excited to be initiating the trial and advancing the OTO-313 program for this important unmet need.”

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