- 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.
