Otonomy’s Phase III trial for Ménière's disease fails to meet endpoints


US-based Otonomy has reported results from a Phase III clinical trial (AVERTS-1) of its drug candidate Otividex (OTO-104) to treat patients with a chronic ear disorder called Unilateral Ménière’s disease.

Otividex is a sustained-exposure formulation of the dexamethasone steroid being developed for Ménière’s disease and cisplatin-induced hearing loss.

As the results showed that the trial has failed to meet the primary endpoint and all key vertigo secondary endpoints, Otonomy is immediately ceasing the development activities for Otividex.

The prospective, randomised, double-blind, placebo-controlled AVERTS-1 trial evaluated the effectiveness of single intratympanic injections of Otividex in 165 subjects over 16 weeks.

The trial’s primary endpoint was the count of definitive vertigo days by poisson regression analysis, and a 58% decrease in vertigo frequency from baseline was observed in the third month compared to 55% for placebo.

"We are greatly disappointed by these results, and surprised by both the higher placebo response and lower Otividex improvement than observed in our previous trials."

Otonomy president and CEO David Weber said: “We are greatly disappointed by these results, and surprised by both the higher placebo response and lower Otividex improvement than observed in our previous trials.

“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."

According to Phase IIb trial top-line results reported in May 2015 from 154 subjects, Otividex demonstrated a 61% decrease from baseline in vertigo frequency in month three, when compared to 43% for placebo.