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

 

• Otonomy (NASDAQ: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.
• 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 trial due to an adverse event.
• Management held a conference call today at 8 a.m. ET, to review the results.
• https://seekingalpha.com/news/3645233-otonomys-otominus-413-shows-clinical-benefit-in-hearing-loss-study