Auris Medical Announces Publication of AM-111 Phase 3 Results in Peer-Reviewed Scientific Journal

Auris Medical Holding AG (NASDAQ:EARS) has announced the publication of an article that details the outcomes from the HEALOS Phase 3 trial with AM-111, Auris Medical’s investigational treatment for acute inner hearing loss.

As quoted in the press release:

The peer-reviewed article “Efficacy and Safety of AM-111 in the Treatment of Acute Unilateral Sudden Deafness – A Double-Blind, Randomized, Placebo-Controlled Phase 3 Study” was published in Otology & Neurotology, one of the leading journals in the field of scientific and clinical inner ear research.

“The HEALOS trial demonstrated that effective hearing protection is possible with a drug-based approach even in the case of profound acute hearing loss, a condition with very poor prognosis for recovery and high risk for life-long auditory and cognitive disability,” commented Hinrich Staecker, MD, PhD, Professor, Department of Otolaryngology Head and Neck Surgery, University of Kansas Medical Center, Kansas City, lead author on the publication. “In the trial, treatment with a single dose of AM-111 resulted in a clinically meaningful hearing recovery and a marked reduction in the risk of no improvement. These outcomes are very promising as there are still no effective drug treatments available to protect hearing.”

The HEALOS trial was conducted in several European and Asian countries as a randomized, double-blind, placebo-controlled study evaluating the efficacy, safety and tolerability of AM-111. It 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. While the HEALOS trial did not meet the primary efficacy endpoint in the overall study population, post-hoc analyses revealed a statistically significant hearing improvement with AM-111 from baseline to Day 28 in the subpopulation of patients with profound hearing loss (n=98). The AM-111 0.4 mg/mL treatment group showed a mean improvement of 42.7 dB vs. 26.8 dB in the placebo group (p=0.0176). AM-111 was well-tolerated and the primary safety endpoint was met.

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