Auris Medical announces interim results from Phase 1b trial with AM-201
Auris Medical Holding announced interim results from its Phase 1b trial with AM-201 in antipsychotic-induced weight gain and somnolence. The study demonstrated good safety and tolerability of AM-201 over the four-week treatment period and revealed relevant reductions in olanzapine-induced weight gain and daytime sleepiness. In female study participants, who overall showed more pronounced changes than male participants, a reduction in weight gain of 1.1 kg against placebo was observed at the highest tested dose of 20 mg three times per day. The study will now proceed to the next higher and final dose level of 30 mg to be tested on 30 healthy volunteers. The Phase 1b trial with AM-201 in antipsychotic-induced weight gain and somnolence is being conducted at a single trial site in Europe and has enrolled 50 healthy volunteers to date. Participants received either AM-201 or placebo three times a day in parallel with oral olanzapine once a day for four weeks. The primary efficacy outcome for the trial is the reduction in olanzapine-induced weight gain; the secondary efficacy outcome is the reduction in olanzapine-induced daytime sleepiness.