Otonomy Lead Drug Succeeds in Late-Stage Study
What a Turnaround: Otonomy Explodes as Lead Drug Succeeds in Late-Stage Study
By Mark Terry
This is particularly good news for the company. On Aug. 30, the company’s AVERTS-1 Phase III trial of Otividex in Meniere’s disease failed to meet its primary endpoint and all key vertigo secondary endpoints. The company responded in mid-September by cutting jobs and slashing operations in order to stay in business.
Meniere’s disease is an inner ear disorder that gives patients vertigo, along with fluctuating hearing loss and a progressively, ultimately permanent hearing loss, and ringing of the ears.
In AVERTS-2, the primary endpoint was count of definitive vertigo days (DVD) by Poisson Regression analysis in Month 3 comparing the drug to placebo. It achieved that endpoint, demonstrating a 6.2 day reduction in the mean reported number of DVD from baseline to Month 3 with a 2.5 day mean difference between Otividex and placebo. In patients who completed daily diaries through the third month, there was a 68 percent decrease in vertigo frequency from baseline in the Otividex group.
“The success of the AVERTS-2 trial clearly demonstrates the treatment benefit of Otividex in patients with Meniere’s disease, and these results are consistent with our expectations based on the Phase IIb trial,” said David Weber, Otonomy’s president and chief executive officer, in a statement. “We will complete analysis of this trial and prepare for discussions with the FDA which we expect to occur during the first quarter of 2018. We will also further assess the AVERTS-1 trial to identify factors that might explain the different outcome in that trial and inform the design of our clinical program to support an NDA filing.”
Company stock popped from $2.80 to $6.20 currently, at the news. That’s a long way from the $20.80 it reported on Aug. 29 just before it reported the failure of the AVERTS-1 trial.
The company has Otiprio (ciprofloxacin otic suspension) on the market for use during tympanostomy tube placement surgery in pediatric patients. It has a supplementary New Drug Application (sNDA) with the U.S Food and Drug Administration (FDA) for acute otitis externa (AOE), and a successful End-of-Phase II review has been wrapped with the FDA for acute otitis media with tympanostomy tubes (AOMT).
There is at least one puzzle over the news. After the failure in August, the company had indicated it was suspending all work on the drug, including the AVERTS-2 trial. John Carroll, with Endpoints News, writes, “Otonomy now plans to hustle the data to regulators to see about the clinical requirements that will need to be met before filing for an approval…. Some of the analysts, though, raised an eyebrow over the data, noting that it was at least partially based on the 105 patients who had completed their diary work on results, out of 174 in the trial. Researchers said that there was a 68 percent reduction in vertigo frequency from baseline to Month 3 in the Otividex group compared to 40 percent for placebo, so there was clearly a placebo response to reckon with.”