OTIC - Otonomy Announces Results from Phase 2 Clinical Trial of OTO-313 in Patients with Tinnitus

Otonomy, Inc. (NASDAQ: OTIC) reported that the OTO-313 Phase 2 trial in tinnitus demonstrated no meaningful benefit versus placebo for primary and secondary endpoints across all timepoints.  The phase 2 trial enrolled 153 patients with unilateral, persistent tinnitus of at least moderate severity.  “These results were unexpected with a much higher placebo response than observed in the prior Phase 1/2 study,” said David A. Weber, Ph.D., president and CEO of Otonomy. “In addition to this trial, we have also reviewed preliminary top-line results for the one-month safety evaluation of higher and bilateral dosing of OTO-313 and did not observe a treatment benefit that is convincing in light of the Phase 2 results. Therefore, we must make the difficult decision for all stakeholders including patients and clinicians who were highly supportive of this trial to discontinue further work on OTO-313. We also intend to implement other measures to extend our cash runway.”

The company’s clinical focus shifts to OTO-413 for the treatment of hearing loss. Positive Phase 2a results for OTO-413 were announced in April 2022, which corroborated findings from an earlier Phase 1/2 study. In addition, enrollment is complete for evaluation of higher dosing with top-line results expected in the fourth quarter of 2022.

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