Otonomy' AVERTS-1 Phase 3 Trial For OTIVIDEX Misses Primary Endpoint

(RTTNews) - Otonomy, Inc. (OTIC) announced that AVERTS-1 Phase 3 clinical trial of OTIVIDEX in patients with Ménière's disease missed its primary endpoint which was the count of definitive vertigo days by Poisson Regression analysis (p=0.62). The trial also failed to achieve statistical significance (p < 0.05) for any of the key secondary vertigo endpoints at Month 3.

Patients in both the OTIVIDEX and placebo groups showed similar reductions in the number and severity of vertigo episodes during the three month observation period. OTIVIDEX patients reported a 58% reduction from baseline in vertigo frequency in Month 3 vs. 55% for placebo patients.

David Weber, president and CEO of Otonomy, said, "We are greatly disappointed by these results, and surprised by both the higher placebo response and lower OTIVIDEX improvement than observed in our previous trials,"

The company said it is immediately suspending all development activities for OTIVIDEX including the ongoing AVERTS-2 trial and is also undertaking a review of its product pipeline and commercial efforts to identify opportunities to extend its cash runway and build shareholder value.