Auris Medical has announced the initiation of a Phase 1b proof-of-concept study of its AM-201 intranasal betahistine, which the company is developing for the prevention of weight gain and sleepiness in patients taking olanzapine. The 4-week dose escalation study is expected to compare 5 different doses of AM-201 to placebo in 50 healthy volunteers who will also receive olanzapine.
Auris has previously announced Phase 1 and pre-clinical data showing higher bioavailability for intranasal betahistine than for oral betahistine. The company is also developing intranasal betahistine for several other indications, including Prader-Willi Syndrome and acute vertigo following vestibular schwannoma resection.
Auris Medical Founder, Chairman, and CEO Thomas Meyer commented, “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. 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.”
Read the Auris Medical press release.
