otonomy meniere's drug trial fails

After Disappointing Results on Phase 3 Trial of Meniere’s Drug, Otonomy Lays off Staff, Suspends Further Trials in 2017

SAN DIEGO, CALIFORNIA — Following disappointing AVERTS-1 Phase 3 trial results of OTIVIDEX in Ménière’s disease patients, Otonomy, Inc., a US-based biopharmaceutical firm, announced that the company is laying off one-third of its noncommercial staff and will not initiate any further clinical trials through the end of 2017. 

With the announcement, the timing for initiation of a Phase 2 clinical trial of OTO-311 (gacyclidine) in tinnitus patients and a Phase 3 registration trial for OTIPRIO (ciprofloxacin otic suspension) in pediatric patients with acute otitis media with tympanostomy tubes will be evaluated as part of the pipeline review and prioritization effort that is currently underway.


Company Reorganization


According to a company statement, preclinical development continues on multiple product candidates for the prevention and/or treatment of sensorineural hearing loss. Product candidates under evaluation target key mechanisms involved in the pathophysiology of hearing loss, including age-related hearing loss.


“We moved quickly following the disappointing AVERTS-1 trial results to focus our efforts in order to reduce costs. I am deeply grateful to the talented individuals dedicated to developing OTIVIDEX for the treatment of Ménière’s disease, and we wish the best for those impacted by the workforce reduction” –David A. Weber, PhD, Otonomy President and CEO


According to Otonomy’s President, Dr. David Weber, “The changes we are making give us the cash runway we need to build shareholder value by focusing on key assets in our product pipeline which we believe is still the broadest in the otology field. We have a tremendous opportunity to utilize our experience, expertise, and resources to address important unmet medical needs such as hearing loss and tinnitus, and I look forward to outlining our plans in future business updates.”


Source: Otonomy