Otonomy (NASDAQ:OTIC) announces a positive development related to the statistical analysis plan for its ongoing Phase 3 clinical trial evaluating Otividex in patients with Ménière’s disease, a disorder of the inner ear that can lead to vertigo and hearing loss.
In response to FDA questions, the company has changed its statistical approach to a Negative Binomial model that, it says, provides the best fit for clinical data and will enable it to drop the enrollment target to 142 from 160. Enrollment should be competed this quarter with topline data available in Q1 2021.
OTIVIDEX (formerly OTO-104), a sustained-exposure formulation of the steroid dexamethasone, was being developed to treat a range of balance and hearing disorders. It is administered directly into the middle ear via injection through the eardrum.
On another note, topline results from a Phase 1/2 clinical trial evaluating OTO-313, a sustained-exposure formulation of the NMDA receptor antagonist gacyclidine, in patients with persistent tinnitus showed a “positive clinical signal.” Specifically, 43% of treated patients responded at day 29 and day 57, defined as at least a 13-point drop in Tinnitus Functional Index (TFI) score from baseline, well head of 13% in the control arm.
Management hosted a conference call today at 4:30 pm to discuss both candidates.
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