OTIC - Otonomy shares rise after initiating expansion of early-stage OTO-413 hearing loss trial

Otonomy (OTIC) announces the initiation of an expansion study for the Phase 1/2 clinical trial of OTO-413 in patients with speech-in-noise hearing difficulty.Shares up more than 10% premarket.OTO-413 is a proprietary, sustained-exposure formulation of brain-derived neurotrophic factor ((BDNF)), which is a naturally occurring protein involved in neuron growth and repair.The randomized, double-blind, placebo-controlled study cohort will enroll about 30 hearing loss patients of which 20 will be treated with a single intratympanic injection of OTO-413 and 10 will receive placebo.The primary assessment of treatment benefit will be based on the proportion of responders in the OTO-413 group vs placebo who demonstrate a clinically-meaningful level of improvement in speech-in-noise hearing from baseline to Months 2 and 3 following treatment.The company expects to post top-line results from the study in mid-2022.

For further details see:

Otonomy shares rise after initiating expansion of early-stage OTO-413 hearing loss trial