Auris Medical Holding AG announced that it has completed patient enrollment in the Phase III HEALOS clinical trial of AM 111 in idiopathic sudden sensorineural hearing loss.

Auris Medical Holding AG announced that it has completed patient enrollment in the Phase III HEALOS clinical trial of AM 111 in idiopathic sudden sensorineural hearing loss (ISSNHL), also known as sudden deafness. Top-line results from the HEALOS trial are expected in the fall of 2017.

The HEALOS trial is a randomized, double-blind, placebo-controlled study evaluating the efficacy, safety and tolerability of single-dose intratympanic administration of AM 111. The trial is being conducted in several European and Asian countries and has enrolled patients who are suffering from severe to profound ISSNHL within 72 hours from onset. Patients were randomized to receive AM-111 0.4 mg/mL, 0.8 mg/mL or placebo in a 1:1:1 ratio. The primary efficacy endpoint for the trial is the improvement of pure tone hearing thresholds from baseline to Day 28.

HEALOS is the first of two pivotal trials in Auris Medical's Phase III clinical development program for AM 111. The second Phase III trial, ASSENT, is set to enroll approximately 300 patients. Auris Medical expects to announce top-line results from the ASSENT trial in the second half of 2018.