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news.Auris Medical has completed patient enrollment in the Phase 3 HEALOS clinical trial of AM-111 in idiopathic sudden sensorineural hearing loss (ISSNHL), also known as sudden deafness.
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Top-line results from the HEALOS trial are expected in the fall of 2017.
"We are very pleased that our first Phase 3 clinical trial of AM-111 is now fully enrolled with 256 patients," commented Thomas Meyer, Auris Medical's founder, Chairman and Chief Executive Officer.
"AM-111 could become the first specific therapeutic for patients with acute inner ear hearing loss, a condition that can severely impact day-to-day functioning. We are proud to have pioneered the development of AM-111 and look forward to results from the HEALOS trial later this year."
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 3 clinical development program for AM-111. The second Phase 3 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.