Otonomy expands Phase 1/2 hearing loss clinical trial

Neurotology drug developer Otonomy (NSDQ:OTIC) is expanding a Phase 1/2 trial of OTO-413 in patients who have difficulty with speech-in-noise tests. In the trial, clinical investigators administer the drug as a single intratympanic injection.

The company said that OTO-413 showed promise in improving hearing in a dose escalation efficacy cohort.

The randomized, double-blind, placebo-controlled Phase 1/2 study will be relatively small, involving approximately 30 hearing loss patients. A total of 20 people will receive OTO-413 with the remainder receiving placebo.

“We are pleased to initiate this expansion study in order to demonstrate the treatment benefit in a larger cohort of hearing loss patients, continue our evaluation of multiple speech-in-noise hearing tests, and provide important information to help us design and power a more formal Phase 2 clinical trial,” said David A. Weber, president and CEO of Otonomy, in a statement.

OTO-413 is a formu…

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