Auris Medical provides update on AM-111 development program
Auris Medical Holding announced further clinical results from the HEALOS Phase 3 clinical trial that investigated AM-111 in the treatment of acute inner ear hearing loss and provided an update on the AM-111 development program. While the HEALOS trial had not met the primary efficacy endpoint in the overall study population, post-hoc analyses of top-line data revealed a clinically and statistically significant hearing improvement with AM-111 from baseline to Day 28 in the subpopulation of patients with profound hearing loss. 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. The improvement was 37.3 dB in the AM-111 0.8 mg/mL group. AM-111 was well tolerated and the primary safety endpoint was met. "These new data from the HEALOS trial are promising, demonstrating a clinically meaningful hearing improvement in those patients with profound hearing loss," commented Hinrich Staecker, MD, PhD, Professor, Department of Otolaryngology Head and Neck Surgery, University of Kansas Medical Center, Kansas City. "Profound sudden deafness can have a major impact on patients' cognitive and auditory function as well as quality of life. It has a poor prognosis, frequently with little or no hearing recovery, and there are no effective treatments. If approved, AM-111 has the potential to address the unmet need for novel therapeutics which can improve hearing during the acute stage of profound sudden deafness and reduce the substantial risk of severe life-long hearing impairment."