Auris Medical’s ear tinnitus drug Keyzilen fails to meet co-primary endpoints in phase 3 trial

The TACTT2 trial did not meet the two co-primary efficacy endpoints of statistically significant changes in tinnitus loudness and tinnitus burden compared to placebo.

Data from the TACTT2 trial support the positive safety profile established in previous studies, and results from the second Phase 3 trial, TACTT3, are expected in the fourth quarter of 2016.

"We are disappointed that our TACTT2 trial did not reach its co-primary efficacy endpoints. The assessment of the trial data is ongoing and we intend to discuss outcomes and our plans for a path forward with regulatory agencies prior to the readout from the TACTT3 trial," commented Thomas Meyer, founder, Chairman and Chief Executive Officer of Auris Medical.

"We would like to sincerely thank all patients, investigators and study site staff participating in TACTT2 for their dedicated contribution to the trial. Acute inner ear tinnitus represents an important unmet medical need and we remain committed to achieving our mission of providing tinnitus patients with effective and safe therapeutic options."

TACTT2 was designed as a randomized, double-blind, placebo-controlled trial in acute inner ear tinnitus following traumatic cochlear injury or otitis media. The trial was conducted primarily in North America and randomized 343 patients to receive either KeyzilenTM 0.87 mg/mL or placebo in a 3:2 ratio.

The co-primary endpoints were the improvement in subjective tinnitus loudness from baseline to Day 84 and the improvement in tinnitus burden from baseline to Day 84, measured by the Tinnitus Functional Index (TFI).

Treatment with KeyzilenTM did not demonstrate a statistically significant difference in tinnitus improvement as compared to placebo for either endpoint. KeyzilenTM was well tolerated with no drug-related serious adverse events.

The trial's primary safety endpoint, incidence of clinically meaningful hearing deterioration, was low with no statistically significant difference from the placebo group, supporting the safety profile of KeyzilenTM.

TACTT3, which is being conducted in Europe, is a randomized, double-blind, placebo-controlled trial in acute and post-acute inner ear tinnitus following traumatic cochlear injury or otitis media.

The trial has enrolled more than 300 patients during the acute tinnitus stage (Stratum A) and approximately 330 patients during the post-acute tinnitus stage (Stratum B). The primary endpoint is the change in tinnitus loudness from baseline to Day 84; the change in the TFI is the key secondary efficacy outcome.