Otonomy shares surge on positive Ménière's data
- Shares in Otonomy Inc., a San Diego biotech with a focus on diseases of the ear, nearly doubled Thursday after the company revealed its Ménière's disease drug Otividex hit its primary objective in a Phase 3 study.
- Otividex, a formulation of the steroid dexamethasone, reduced the number of definitive vertigo days from baseline through month 3 compared to placebo.
- Patients in the Otividex group experienced an average of 6.2 fewer vertigo days versus baseline — 2.5 days more than the average reduction seen in the control arm. The frequency of vertigo also fell by 68% for patients on Otividex who completed daily diaries as compared to a 40% lowering for placebo.
This week's stock boom for Otonomy follows a similarly sized change in the other direction earlier this year, when the company's AVERTS-1 Phase 3 trial failed to show any benefit to Otividex in Ménière's disease.
The drug, previously known as OTO-104, had also narrowly missed a primary endpoint in reduction of vertigo frequency in a Phase 2b trial two years ago. At the time of AVERTS-1, however, Otonomy had "no explanation for the unequivocal negative results of this trial" as it didn't match up with results from other earlier clinical trials.
Those negative results led to some major changes. In September, Otonomy announced suspension of all development activities for Otividex, including termination of ongoing clinical trials and pre-registration efforts, and layoffs for a third of non-commercial staff. Planned clinical trials, including a Phase 2 clinical trial of OTO-311 (gacyclidine) in tinnitus patients and a Phase 3 study for Otiprio (ciprofloxacin) in pediatric patients with acute otitis media with tympanostomy tubes (AOMT), were put on hold.
Yet, this new data could help turn things around for Otividex. Analysis of AVERTS-2, which was close to completion at the time of the suspension, demonstrated a much more positive spin, and Otonomy plans to start discussions with the Food and Drug Administration over the drug's future.
Once that is out of the way, the next step for the company will be to see if it can pull together the resources to reboot its stalled development pipeline and move forward.
- Otonomy Inc. Press release
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