Auris Medical: update on the AM-111 clinical development program

The study is investigating AM-111, a biodegradable gel that is administered in a single-dose intratympanic injection into the middle ear. AM-111 is aimed at treating acute inner ear hearing loss. The target population is patients with severe to profound sudden deafness to be treated within 72 hours from onset.

The company provided further results and gave an update on the AM-111 development program. Although the HEALOS trial failed to meet 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, Auris indicated. This group included 98 patients.

“We are very pleased to see further evidence of AM-111’s efficacy in the profound hearing loss patients in the HEALOS trial,” said Thomas Meyer, Auris Medical’s founder, Chairman and Chief Executive Officer in the press release from the company. “The superior improvement in word recognition provides additional support for AM-111’s positive impact on auditory function; the significant reduction in the risk of no improvement shows another otoprotective aspect in this challenging condition.”

Looking forward, Meyer added that the similarity of outcome patterns between the HEALOS study and the Phase 2 trial already completed provides further confirmation of AM-111’s therapeutic benefits. “We remain dedicated to bringing AM-111 to patients suffering from this orphan disease and look forward to discussing the path forward with the regulatory agencies.”

Source: Auris Medical