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United Kingdom

Auris Medical Announces Results Of Pre-IND Meeting With FDA For AM-201 Program In Olanzapine-Induced Weight Gain


Tuesday, 20 Nov 2018 

Nov 20 (Reuters) - Auris Medical Holding AG ::AURIS MEDICAL ANNOUNCES RESULTS OF PRE-IND MEETING WITH FDA FOR AM-201 PROGRAM IN OLANZAPINE-INDUCED WEIGHT GAIN.AURIS MEDICAL HOLDING AG - COMPANY PLANS TO INITIATE A PHASE 1 PHARMACOKINETIC/PHARMACODYNAMIC STUDY IN Q1 OF 2019 TO EVALUATE AM-201.AURIS MEDICAL- FDA SUPPORTS PLANNED CONDUCT OF MULTIPLE DOSE PHASE 1 TRIAL WITH AM-201 ADMINISTERED TO HEALTHY SUBJECTS IN COMBINATION WITH OLANZAPINE.AURIS MEDICAL HOLDING AG - FOLLOWING READ-OUT FROM STUDY, CO EXPECTS TO FILE IND APPLICATION FOR AM-201 LATER IN 2019.AURIS MEDICAL-FDA ENDORSED WEIGHT GAIN NORMALIZED TO BASELINE BODY WEIGHT VERSUS PLACEBO AS REASONABLE PRIMARY EFFICACY ENDPOINT FOR SUBSEQUENT PHASE 2 TRIAL. 

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