After biopharmaceutical Otonomy (OTIC 4.00, -16.80 -80.8%) announced results for its AVERTS-1 Phase 3 clinical trial of OTIVIDEX in patients with Ménière’s disease shares began to run for the hills, making all-time lows below the $4 mark.
Notably, the clinical trial missed its primary endpoint which was the count of definitive vertigo days by Poisson Regression analysis (p=0.62). 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.
The trial also failed to achieve statistical significance (p < 0.05) for any of the key secondary vertigo endpoints at Month 3.
“Based on these results, we are immediately suspending all development activities for OTIVIDEX including the ongoing AVERTS-2 trial. In addition, the company is undertaking a review of its product pipeline and commercial efforts to identify opportunities to extend its cash runway and build shareholder value,” said CEO David Weber.
As of June 30, 2017, the company held cash, cash equivalents, and short-term investments totaling $150.5 million with prior non-GAAP operating expense guidance of $80-85 million for 2017. The company is withdrawing the spending guidance for the year pending the above-mentioned review.
Now that OTIVIDEX has been suspended the focus will likely turn to the company’s treatment of acute otitis externa, OTIPRIO. OTIPRIO was accepted by the FDA in mid-July and has a PDUFA date set for March 2, 2018.