Otonomy Reports Results of OTO-413 in P-IIa Clinical Trial for the Treatment of Hearing Loss
Shots:
- The P-IIa trial evaluates OTO-413 (0.3mg) as single intratympanic vs PBO in 33 patients with hearing loss
- The results from the 30 patients included 20 with OTO-413 & 10 with PBO showed 40% improvement on 1 of 3 SIN tests (40% vs 20%); improvement by 2 different SIN tests (15% vs 0%) @Day 57 & 85; words-in-noise test (40% vs 0%); responder rate was favorable with an improvement in 1 SIN test (41% vs 13%)
- PGIC showed a treatment benefit (50% vs 10%), was well tolerated with no SAEs & no patient discontinued, patients reported AE (32% vs 46%). The company plans to initiate a full dose-ranging P-II trial at the end of 2022 & enrollment in higher dose cohorts is ongoing with expected results in H2’22
Ref: Globe Newswire | Image: Otonomy
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