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Auris Medical Announces Randomization of First Dose Cohort in AM-201 Phase 1b Proof-of-Concept Study
Mar. 29, 2019 09:53AM PST
Biotech InvestingAuris Medical (NASDAQ:EARS) has announced the first cohort of subjects have been randomized in its Phase 1b proof-of-concpet trial of AM201, which is the company’s investigational drug for preventing antipsychotic-induced weight gain and somnolence. As quoted in the press release: The Phase 1b trial with AM-201 is being conducted at one European site. The trial …
Auris Medical (NASDAQ:EARS) has announced the first cohort of subjects have been randomized in its Phase 1b proof-of-concpet trial of AM201, which is the company’s investigational drug for preventing antipsychotic-induced weight gain and somnolence.
As quoted in the press release:
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 only five months after demonstrating significantly higher plasma levels with intranasal delivery of betahistine in a previous trial,” commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “We expect, if all goes well, to obtain top-line data from the trial during the third quarter and thus obtain swiftly the first proof-of-concept data with AM-201. Prior preclinical and clinical work with oral betahistine has already provided evidence for the compound’s effect on antipsychotic-induced weight gain and somnolence.”