Auris Medical Receives Positive Scientific Advice from EMA on Development Plan and Regulatory Pathway for AM-111

Auris Medical (NASDAQ:EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology, announced today 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.

As quoted in the press release:

The Scientific Advice (Protocol Assistance) had been requested by the Company following the results of the HEALOS phase 3 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.

Click here to read the full press release.