Otonomy, Inc. announced that the clinical evaluation of higher doses for OTO-413 (0.75 mg and 1.50 mg) in patients with hearing loss demonstrated no clinically meaningful improvement for patients from baseline across multiple speech-in-noise (SIN) hearing tests. These results are in contrast to the positive clinical signal observed with 0.3 mg OTO-413 versus placebo in the previous Phase 1/2 and Phase 2a trial cohorts using the same study design and endpoints. The randomized, double-blind, placebo-controlled higher dose cohorts enrolled patients who self-reported difficulty hearing in a noisy environment that was confirmed with a SIN hearing test.

In each dose cohort, nineteen patients were randomized 2:1 to a single intratympanic injection of OTO-413 (0.75 mg or 1.50 mg) or placebo. Patients were assessed with the same SIN tests utilized in prior cohorts including the Words-in-Noise (WIN) test, with the assessment of treatment benefit based on demonstration of a clinically meaningful improvement from baseline versus placebo at both Days 57 and 85.