Otonomy Inc (NASDAQ: OTIC) has announced that the OTO-313 Phase 2 trial in tinnitus demonstrated no clinically meaningful benefit versus placebo for primary and secondary endpoints across all time points.
The 153-subject study did show a higher response rate than placebo in a prospectively defined patient subgroup with tinnitus duration of fewer than six months (population studied in Phase 1/2 trial).
The overall results do not support further development of OTO-313.
"These results were unexpected with a much higher placebo response than observed in the prior Phase 1/2 study," said David Weber, president & CEO of Otonomy.
In addition to this trial, the company also reviewed preliminary top-line results for the one-month safety evaluation of higher and bilateral dosing of OTO-313. It did not observe a clear treatment benefit in light of the Phase 2 results.
Hence, Otonomy will discontinue working on OTIC-313 and shift its focus to OTO-413 for hearing loss.
Enrollment is complete for evaluating higher dosing with top-line results expected in Q4 of 2022.
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