Otonomy Begins Phase 1/2 Trial of OT-413 for Hearing Loss

- September 17th, 2019

Otonomy (NASDAQ:OTIC) has announced it has begun a Phase 1/2 clinical trial of OTO-413 in patients with hearing loss. As quoted in the press release: The Phase 1/2 trial is a randomized, double-blind, placebo-controlled, single ascending dose study designed to evaluate the safety and exploratory efficacy of OTO-413 in patients with speech-in-noise hearing difficulty. “Recent … Continued

Otonomy (NASDAQ:OTIC) has announced it has begun a Phase 1/2 clinical trial of OTO-413 in patients with hearing loss.

As quoted in the press release:

The Phase 1/2 trial is a randomized, double-blind, placebo-controlled, single ascending dose study designed to evaluate the safety and exploratory efficacy of OTO-413 in patients with speech-in-noise hearing difficulty.

“Recent scientific research in the neurotology field has demonstrated that damage or loss of synaptic connections between inner ear hair cells and spiral ganglion neurons, known as cochlear synaptopathy, is involved in the hearing difficulty that many people experience in a loud environment, and that this pathology may also play a role in age-related and noise-induced hearing loss,” said Andrea Vambutas, M.D., Director for the Center of Hearing & Balance at the New York Head & Neck Institute. “Repair of the synaptic connection through local administration of a neurotrophic factor such as BDNF holds promise for patients with speech-in-noise hearing difficulty, and this Phase 1/2 clinical trial provides an exciting first opportunity to evaluate this therapeutic approach.”

“Initiating this clinical trial as planned keeps us on track to have results for three clinical programs in 2020 – the OTIVIDEX™ Phase 3 trial in Ménière’s disease in the first half of 2020, the OTO-313 Phase 1/2 trial in tinnitus patients in the first half of 2020, and this OTO-413 Phase 1/2 trial in the second half of 2020,” said David A. Weber, Ph.D., president and CEO of Otonomy. “Furthermore, advancing this program into clinical development also highlights our leadership in neurotology with clinical-stage programs addressing hearing loss, tinnitus, and balance disorders, the largest indications and market opportunities in this emerging field.”

Click here to read the full press release.

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