Shares of biopharmaceutical company Otonomy Inc (NASDAQ: OTIC) are falling premarket on Monday after the company revealed its Phase 3 trial of OTIVIDEX in patients with Ménière’s disease did not achieve the primary endpoint.
“We are disappointed by the top-line results for the primary intent-to-treat population and are undertaking an assessment to understand the difference observed with the per-protocol analysis,” said David A. Weber, president and CEO of Otonomy.
“Our focus turns to the strong pipeline we have built as recently highlighted by the successful clinical trial results for OTO-313 in tinnitus and OTO-413 in hearing loss,” added Weber.
The trial's primary endpoint was the count of definitive vertigo days in Month 3 for OTIVIDEX vs placebo for the intent-to-treat population using the Negative Binomial Model.
Otonomy’s share price has fallen over 49% following the news, currently trading at $2.73 per share.