Auris Medical Announces Results of Pre-IND Meeting With FDA For AM-201 Program in Olanzapine-Induced Weight Gain
Auris Medical Holding AG (EARS)
Last auris medical holding ag earnings: 8/10 06:31 am
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US:NASDAQ Investor Relations:
ir.aurismedical.com
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Source: GlobeNewswire
Zug, Switzerland, November 20, 2018 - Auris Medical Holding AG (NASDAQ: 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
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