ZUG, SWITZERLAND — Biopharmaceutical company Auris Medical Holdings announced today that it has received feedback from a Type C meeting with the U.S. Food and Drug Administration (FDA) related to the development plan and regulatory pathway for AM-111, the company’s investigational treatment for sudden sensorineural hearing loss.
The meeting had been conducted at the request of Auris Medical, following the results of the company’s HEALOS phase 3 trial. Results from the trial, 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 sub-population of patients studied with acute profound hearing loss. This sub-group of patients were initially “completely deaf or almost deaf on the affected ear and normally would have faced a particularly poor prognosis for hearing recovery”.
AM-111 is being developed in a biocompatible gel formulation for the treatment of sudden sensorineural hearing loss with a single-dose administration into the middle ear.
Sudden Hearing Loss Treatment
According to the announcement, the FDA reviewed Auris Medical’s proposed concept for a placebo-controlled pivotal trial with AM-111 0.4 mg/mL in patients suffering from acute, profound hearing loss. The trial protocol builds to a large extent on the design and outcomes from HEALOS and also incorporates specific feedback provided by the European Medicines Agency (EMA) earlier this year.
In a written response to the company, the FDA endorsed the proposed choice of primary and secondary efficacy endpoints, the safety endpoints, as well as the planned sample size and statistical methodology. Additionally, the FDA provided guidance on the regulatory path forward.
“We very much appreciate the FDA’s feedback and guidance for our AM-111 program. We are very pleased to be aligned with the FDA and EMA on key design aspects for the planned phase 3 trial and look forward to working with the agencies as we continue to develop AM-111 as a potential first-in-class treatment for sudden sensorineural hearing loss.”
–Thomas Meyer, Auris Medical’s founder, chairman and CEO
AM-111 currently has orphan drug designation from both the US Food and Drug Administration and the European Medicines Agency, and it was granted Fast Track status by the FDA. . The company says it intends to continue moving the development of the AM-111 program forward through partnering.
Source: Auris Medical