The buck stops ear: Hearing loss biotech to look for 'strategic options' as data analyses prove fruitless

13 Oct 2022
Gene Therapy
A California biotech focused on developing treatments for neurological conditions of the ear appears to be thinking about closing up shop. San Diego-based Otonomy said Thursday it would “explore strategic options,” code for selling all its assets and possibly itself, after one of its ear compounds did not improve patients’ hearing loss in a clinical analysis. The decision comes two months after a separate program failed a Phase II test, which slashed its stock price $OTIC more than 70% at the time. Thursday, with Otonomy shares already sitting at $0.26 pre-open, investors ran for the hills and sent the stock down another 37% in pre-market trading. In a prepared statement, CEO David Weber noted the “challenging financing environment” as part of what led to the decision. “We intend to explore strategic options to advance and realize value from our pipeline including both OTO-413 and OTO-825, our gene therapy program for congenital hearing loss,” Weber said. The data released Thursday deal with OTO-413, what had been the new lead program following August’s Phase II fail. Otonomy said Thursday morning that after examining higher doses of OTO-413, it found the compound did not improve patients’ scores from baseline on multiple speech-in-noise (SIN) hearing tests. The biotech claimed to have seen a “positive clinical signal” in earlier trials, but the new evaluation did not confirm those findings. Thursday’s report comes shortly after the Phase II miss in August, which showed the company’s candidate OTO-313 did not beat placebo in treating tinnitus. At the time, Otonomy said it would engage in cost-cutting measures but hadn’t yet taken the step to seek selling off its programs. And Otonomy is no stranger to failure. A Phase III flop in an inner ear disease in 2017 led to layoffs. Another late-stage failure in that same condition, known as MénièreMénière’s disease, came in 2021, with investors feeling burned and sending shares down more than 45%.
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