ZUG, SWITZERLAND — Biopharmaceutical company Auris Medical Holdings announced today that it has completed patient enrollment in the Phase 3 trial of its novel AM-111 drug, to treat idiopathic sudden sensorineural hearing loss (ISSNHL)–also known as sudden deafness.
Results from the trial are anticipated to be available in the fall of this year.
The HEALOS trial of AM-111, is a randomized, double-blind, placebo-controlled study evaluating the drug’s efficacy, safety and tolerability of single-dose intratympanic administration. According to the company, the clinical trials are being conducted in several European and Asian countries in patients suffering from severe to profound ISSNHL, within 72 hours from onset.
Patients selected were randomized to receive either AM-111 0.4 mg/mL, 0.8 mg/mL, or a placebo, in a 1:1:1 ratio. The trial will examine improvement of pure tone hearing thresholds from baseline measurement, compared to Day 28.
“We are very pleased that our first Phase 3 clinical trial of AM-111 is now fully enrolled with 256 patients. 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.” –Thomas Meyer, Founder, Chairman and CEO of Auris Medical
HEALOS, according to the company’s press release, is the first of two trials in AM-111’s Phase 3 clinical development program. The second Phase 3 trial, named ASSENT, is set to enroll approximately 300 patients.
The company says it will have top-line results from the upcoming ASSENT trial available in the later half of 2018.