CHMP endorses new pivotal trial of AM 111 for patients with acute profound hearing loss. -Auris Medical

Auris Medical Holding AG announced that the Company has received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) related to the development plan and regulatory pathway for AM 111, its investigational treatment for acute inner ear hearing loss.

The Scientific Advice (Protocol Assistance) had been requested by the Company following the results of the HEALOS phase III trial. The results showed, based on a post-hoc analysis, a clinically meaningful and nominally significant improvement in hearing for the AM 111 0.4 mg/mL group compared to placebo in the subpopulation of patients with acute profound hearing loss. These patients were initially completely deaf or almost deaf on the affected ear and normally would have faced a particularly poor prognosis for hearing recovery.

The EMA reviewed the Company's proposed concept for a single pivotal trial with AM 111 0.4 mg/mL in patients suffering from acute profound hearing loss, which builds to a large extent on the design and outcomes from HEALOS. The Agency endorsed the proposed trial design, choice of efficacy and safety endpoints, as well as the statistical methodology. In addition, the EMA provided important guidance on the regulatory path forward and the maintenance of AM 111's orphan drug designation.