Otonomy's OTO-825 Gene Therapy Can Restore Meaningful Hearing Function, Animal Study Shows

Otonomy Inc OTIC may have hit a snag with the development of its lead ear disorder candidate Otividex. Still, the company is trumpeting an early win for a gene therapy designed to treat congenital hearing loss.
The drug candidate, dubbed OTO-825, reduced hearing loss and repaired structural damage in the inner ear in two mouse models of genetically driven hearing deficiency. Otonomy and its partner Applied Genetic Technologies Corporation AGTC reported the data at the American Society of Gene & Cell Therapy annual meeting.
The OTO-825 news came on the heels of the phase 3 failure of Otonomy’s former lead candidate Otividex to treat the inner ear condition Ménière’s disease.
Based on the encouraging results, the companies are preparing an FDA application to start a first-in-human clinical trial.
Otonomy tested OTO-825 in two different mouse models with partially crippled GJB2 to mimic severe and intermediate hearing loss in humans.
According to the presentation, one injection administered into the inner ears of the mice improved the animals’ hearing function and the organ’s structure.
There are three rows of outer hair cells in a normal mouse and a single row of inner hair cells in the cochlea. These are damaged or missing in the genetically modified mice with dysfunctional GJB2. But OTO-825 restored those structures, a showing that was consistent with the hearing function improvement.
Price Action: OTIC shares are up 2.14% at $2.15, and AGTC shares are up 5.7% at $3.88 during the market session on the last check Friday.

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