OTIC - Otonomy's OTO-413 shows clinical benefit in hearing loss study

Otonomy (OTIC) gains 10% in premarket on the heels of positive top-line results from Phase 1/2 trial evaluating OTO-413 in subjects with speech-in-noise hearing difficulty. Results include the 9 subjects from the OTO-413 high dose (0.3 mg) cohort with test results on both Day 57 and Day 85 and 8 placebo.The trial demonstrated that a single intratympanic injection of OTO-413 was well-tolerated across all dose cohorts, as well as showed therapeutic activity versus placebo across multiple clinically-validated speech-in-noise hearing ((SIN)) tests.6/9 OTO-413 subjects demonstrated a clinically-meaningful improvement on at least one of the three SIN tests at both Days 57 and 85 versus 0/8 for placebo.While 3 out of 9 OTO-413 subjects demonstrated a clinically-meaningful improvement by two or more different SIN tests vs. 0 in placebo.Improvements from baseline were also observed for multiple other exploratory endpoints and for OTO-413 in lower dose cohorts.On the safety front, no serious adverse events were reported and no patients who discontinued the

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Otonomy's OTO-413 shows clinical benefit in hearing loss study