Auris Medical announced positive results from a phase II b clinical trial with AM-101, its investigational drug for the intratympanic treatment of acute inner ear tinnitus. The study demonstrated that the treatment was very well tolerated and showed a statistically significant treatment effect.

The double-blind, randomized, placebo-controlled, parallel-dose phase II b study with AM-101 was con-ducted in Germany, Belgium, Poland and the Netherlands, involving almost 30 sites. A total of 248 patients suffering from persistent acute inner ear tinnitus were randomized to receive 3 intratympanic injections of either AM-101 at 0.27 or 0.81 mg/ml or placebo over 3 consecutive days. Their tinnitus had to be triggered by acute acoustic trauma, sudden deafness or otitis media and to be no older than 3 months. The clinical trial evaluated the safety and local tolerance of AM-101 and various efficacy outcomes. Study participants were monitored over 90 days.

Preliminary results from the phase II b study show that the local treatment with AM-101 was very well tolerated, and in particular that it had no negative impact on hearing. In addition, the study demonstrated a dose-dependent improvement in various measures of tinnitus impairment, disability and handicap. Patients suffering from acute tinnitus with established cochlear origin who received AM-101 at 0.81 mg/ml showed a statistically significant reduction in tinnitus loudness, sleep impact and the THI-12 questionnaire score (p <0.05 or <0.01). Further information on the clinical trial and detailed outcomes shall be published in a scientific journal.

“We are very pleased with the positive results from this important clinical trial with AM-101,” stated Thomas Meyer, Auris Medical’s founder and managing director. “The study confirmed the excellent safety profile of the treatment and established proof of concept for efficacy in humans.” He added that the successful conclusion of the study represented a great step forward in the development of a treatment for inner ear tinnitus, an area of great unmet medical need. Auris Medical is planning now to discuss the results from the phase II b trial with regulatory agencies and to prepare the next development steps for AM-101.