Zug, Switzerland, November 20, 2018 - Auris Medical Holding AG (EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and mental health supportive care, today announced the results of its pre-Investigational New Drug (pre-IND) meeting with the United States Food & Drug Administration (FDA), where the FDA addressed the Company's questions and provided guidance on its AM-201 program with intranasal betahistine for the prevention of olanzapine-induced weight gain.
In its written response, the FDA supported the planned conduct of a multiple dose Phase 1 trial with AM-201 administered to healthy subjects in combination with olanzapine to evaluate the pharmacokinetics, pharmacodynamics, and safety, and to establish proof-of-concept. Further, the FDA endorsed weight gain normalized to baseline body weight versus placebo as reasonable primary efficacy endpoint for a subsequent Phase 2 trial. The Agency deemed the 505(b)(2) pathway appropriate for the AM-201 program as the Company intends to rely on part of its future submission dossier on existing data from other parties and sources.
"We are very pleased with the outcomes of the pre-IND meeting with the FDA as it provided important confirmation and guidance for our AM-201 development plans," commented Thomas Meyer, Auris Medical's founder, Chairman and CEO. "Following this milestone, we look forward to moving ahead with our development program and to continuing our work towards the development of an effective and safe treatment for the prevention of antipsychotic-induced weight gain."
The Company plans to initiate a Phase 1 pharmacokinetic/pharmacodynamic study in the first quarter of 2019 to evaluate AM-201 in the prevention of olanzapine-induced weight gain. The randomized double blind placebo controlled proof-of-concept trial will be conducted in a European country and enroll 50 healthy volunteers who will receive either AM-201 or placebo concomitantly with olanzapine over four weeks. Doses will be escalated in five steps. Following the read-out from the study, the Company expects to file the IND application for AM-201 later in 2019.
About Auris Medical
Auris Medical is a Swiss biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in neurotology and mental health supportive care. The company is focused on the development of intranasal betahistine for the treatment of vertigo (AM-125) and for the treatment of antipsychotic-induced weight gain and somnolence (AM-201). This program is currently in Phase 1. In addition Auris Medical has two Phase 3 programs under development: Sonsuvi® (AM-111) for acute inner ear hearing loss and Keyzilen® (AM-101) for acute inner ear tinnitus. The Company was founded in 2003 and is headquartered in Zug, Switzerland. The shares of Auris Medical Holding AG trade on the NASDAQ Capital Market under the symbol "EARS."
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