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Otonomy Hearing Loss Candidate Shows Clinical Benefit On Multiple Efficacy Endpoints

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  • Otonomy Inc (NASDAQ: OTIC) announced topline 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 OTO-413 provided clinically meaningful treatment benefit versus placebo across multiple speech-in-noise (SIN) hearing tests and the Patient Global Impression of Change at consecutive time points (Days 57 and 85).

  • 40% (8 of 20) of OTO-413 subjects demonstrated a clinically meaningful improvement on at least one of the three SIN tests versus 20% (2 out of 10) for placebo.

  • Also See: Otonomy's OTO-825 Gene Therapy Can Restore Meaningful Hearing Function, Animal Study Shows.

  • 15% (3 of 20) OTO-413 subjects demonstrated a clinically-meaningful improvement by two or more 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 a clinically meaningful improvement versus 0% (0 of 9 with evaluable tests) for placebo.

  • Treatment with OTO-413 was well tolerated. 32% of OTO-413 and 46% of placebo subjects reported an AE, most of which were mild.

  • Otonomy intends to initiate a full dose-ranging Phase 2 trial in hearing loss patients by the end of 2022, incorporating learnings from the ongoing higher dose evaluations assessing two higher doses of OTO-413: 0.75 mg and 1.50 mg.

  • Results from the higher dose evaluation are expected in 2H of 2022.

  • Price Action: OTIC shares are up 0.46% at $2.11 during the market session on the last check Wednesday.

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