Auris Medical Announces Randomization of First Dose Cohort in AM-201 Phase 1b Proof-of-Concept Study
Auris Medical Holding AG (EARS)
Last auris medical holding ag earnings: 8/10 06:31 am
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Source: GlobeNewswire
Hamilton, Bermuda, March 29, 2019 - Auris Medical Holding Ltd. (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, today announced that the first cohort of subjects have been randomized in its Phase 1b proof-of-concept trial of AM-201, the Company's investigational drug for the prevention of antipsychotic-induced weight gain and somnolence. The Phase 1b trial with AM-201 is being conducted at one European site. The trial will enroll in total 50 healthy volunteers who will receive either AM-201 or placebo concomitantly with the antipsychotic drug olanzapine over four weeks. The protocol is based on a dose escalation with five different doses of intranasal betahistine. The primary efficacy outcome will be the reduction in weight gain and the secondary outcome will be the reduction in somnolence. "We are excited to have started the Phase 1b trial with AM-201 o
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