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A total of 30 hearing loss patients will be enrolled in the randomized, double-blind, placebo-controlled research group, with 20 receiving OTO-413 injections and 10 receiving placebo shots.
FREMONT, CA: Otonomy, a biopharmaceutical company focused on the development of novel neurotology treatments, announced the start of an extension study for the OTO-413 Phase 1/2 clinical trial in patients with speech-in-noise hearing impairment. A total of 30 hearing loss patients will be enrolled in the randomized, double-blind, placebo-controlled research group, with 20 receiving OTO-413 injections and 10 receiving placebo shots.
The same three clinically validated speech-in-noise hearing tests used in previous cohorts will be used to measure treatment activity:
The American English Matrix phrase test.
The Words-in-Noise test.
The Digits-in-Noise test.
In mid-2022, top-line results are expected.
“The results presented from the dose escalation efficacy cohort provide initial clinical validation of OTO-413 for the treatment of speech-in-noise hearing difficulty, which is commonly reported by patients with hearing loss due to noise exposure or aging,” said David A. Weber, Ph.D., President and CEO, Otonomy. “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.”
The Phase 1/2 expansion study will enroll around 30 patients with self-reported hearing loss validated by a speech-in-noise hearing test at multiple clinical sites across the United States. The proportion of responders in the OTO-413 group versus placebo who demonstrate a clinically relevant level of improvement in speech-in-noise hearing from baseline to Months 2 and 3 following treatment will be the key measure of treatment benefit.
