Phase II success for AM 111 (Auris Medical) for acute sensorineural hearing loss

Auris Medical has announced positive results from a Phase IIb clinical trial with AM-111, its investigational drug for the intratympanic (i.t.) treatment of acute sensorineural hearing loss (ASNHL). The study demonstrated that the treatment was well tolerated and showed a statistically significant and clinically relevant treatment effect.

The double-blind, randomized, placebo-controlled phase IIb study with AM-111 involved a total of 210 patients suffering from acute acoustic trauma or sudden deafness who were enrolled within the first 48 hours following the incident. Study participants received one single dose of either AM-111 at 0.4 or 2 mg/ml or placebo by way of i.t. injection and were followed for 90 days.Preliminary results from the phase IIb study show that the local treatment with AM-111 was well tolerated. In addition, the study demonstrated a substantial improvement in hearing threshold and speech discrimination score. In subjects with severe to profound hearing loss who were treated with AM-111 0.4 mg/mL, the primary study endpoint, absolute hearing improvement in the 3 most affected contiguous test frequencies from baseline to Day 7, was met (p < 0.02, compared with placebo). Importantly, the improvement in the speech discrimination score from baseline to Day 7 showed also a statistically significant difference between AM-111 and placebo treated study subjects (p < 0.02). The differences in hearing and speech discrimination recovery between treatment groups appeared as early as on Day 3 and were clinically relevant.