Candidate for otonomy hearing loss shows clinical benefit across multiple efficacy parameters

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  • Otonomy Inc OTIC announced top results from the Phase 2a clinical trial of OTO-413 in subjects with hearing loss.
  • The trial demonstrated that a single intratympanic injection of 0.3 mg of OTO-413 provided clinically significant treatment benefit over placebo on multiple speech-in-noise (SIN) hearing tests and global impression change of patient at consecutive time points (days 57 and 85).
  • 40% (8 of 20) of OTO-413 subjects demonstrated clinically meaningful improvement on at least one of the three SIN tests versus 20% (2 of 10) for placebo.
  • Also see: Otonomy’s OTO-825 Gene Therapy May Restore Significant Hearing Function, Animal Study Shows.
  • 15% (3 of 20) of OTO-413 subjects demonstrated clinically meaningful improvement by at least two different SIN tests versus 0% (0 of 10) for placebo.
  • For the Words-in-Noise test, 40% (6 of 15 with evaluable tests) of OTO-413 subjects demonstrated clinically meaningful improvement compared to 0% (0 of 9 with evaluable tests) for placebo.
  • Treatment with OTO-413 was well tolerated. 32% of OTO-413 subjects and 46% of placebo subjects reported an AE, most of which were mild.
  • Otonomy intends to initiate a full dose-finding Phase 2 trial in patients with hearing loss by the end of 2022, incorporating learnings from ongoing higher dose evaluations evaluating two doses higher levels of OTO-413: 0.75 mg and 1.50 mg.
  • The results of the highest dose assessment are expected in 2H of 2022.
  • Price action: OTIC shares were up 0.46% at $2.11 in the last check trading session on Wednesday.
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