Auris Medical initiates Phase III trial for AM 111 to treat idiopathic sudden sensorineural hearing loss.

Auris Medical Holding AG announced enrollment of the first patient into the pivotal HEALOS clinical trial with AM-111. HEALOS will evaluate the efficacy, safety and tolerability of single dose intratympanic injections of AM-111 in the treatment of idiopathic sudden sensorineural hearing loss (ISSNHL; a.k.a. "sudden deafness").

The trial will enroll 255 patients suffering from acute severe to profound hearing loss within 72 hours from ISSNHL onset. They will be randomized to receive either AM-111 at 0.4 mg/mL or 0.8 mg/mL or placebo. Auris Medical benefited for the design of the HEALOS trial from multiple discussions with European and US regulatory agencies. The primary efficacy endpoint for the trial is the improvement of pure tone hearing thresholds from baseline to Day 28 at the average of the three most affected contiguous test frequencies. HEALOS will be conducted in several European and Asian countries, involving more than 70 sites. It is the first of two pivotal trials in Auris Medical's phase III clinical development program with AM-111. The second trial, ASSENT, is expected to start enrolment in North America in the first half of 2016.

Comment: To date, there exists no treatment for acute inner ear hearing loss with proven efficacy.