Profound sudden deafness trial inconclusive

Auris Medical Holding AG announced top-line results from the HEALOS Phase III clinical trial of AM 111 in severe to profound sudden deafness. Overall, the HEALOS trial did not meet the primary efficacy endpoint of a statistically significant improvement in hearing from baseline to Day 28 compared to placebo for either active treatment groups. However, a post-hoc analysis of the subpopulation with profound acute hearing loss revealed a clinically and statistically significant improvement in the AM 111 0.4 mg/mL treatment group.

The HEALOS trial is a randomized, double-blind, placebo-controlled study evaluating the efficacy, safety and tolerability of AM 111. The trial was conducted in several European and Asian countries and enrolled 256 patients suffering from severe to profound sudden deafness within 72 hours from onset. Patients were randomized in a 1:1:1 ratio to receive a single dose of either AM 111 0.4 mg/mL, AM 111 0.8 mg/mL or placebo, administered into the middle ear. The hearing improvement at the three worst affected contiguous test frequencies at Day 28 was 38.4 dB for patients in the AM 111 0.4 mg/mL group compared to 33.4 dB for the placebo group (p=0.226). For patients in the AM 111 0.8 mg/mL group the improvement was 36.6 dB (p=0.448). Post-hoc analysis in the subpopulation of patients with profound hearing loss[1] (n=98) showed an improvement at Day 28 of 42.7 dB in the AM 111 0.4 mg/mL group vs. 26.8 dB in the placebo group, which was statistically significant (p=0.0176). The improvement was 37.3 dB in the AM 111 0.8 mg/mL group (p=0.126). In addition, AM 111 was well tolerated and the primary safety endpoint was met.

There was no significant difference in the occurrence of clinically relevant hearing deterioration between either of the active treated groups and the placebo group at Day 28. Based on the findings from the HEALOS trial, Auris Medical has concluded that the very similar design of the currently ongoing ASSENT trial is no longer adequate for testing AM 111. Therefore the ASSENT trial will be terminated early.