The company announced results from its Phase 1b trial with AM-201 in antipsychotic-induced weight gain and somnolence.
Auris Medical Holding (NASDAQ:EARS) has announced positive interim results from its Phase 1b trial with AM-201 in antipsychotic-induced weight gain and somnolence.
As quoted in the press release:
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 (probability of effectiveness = 90%). The study will now proceed to the next higher and final dose level of 30 mg to be tested on 30 healthy volunteers.
“We are very pleased to see the good safety and tolerability of intranasal betahistine confirmed over an extended period of time and are encouraged by the first efficacy signals observed in the indication of antipsychotic-induced weight gain and somnolence prevention“, commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “We look forward to confirming and expanding these results in a larger dose cohort in the second leg of the study, for which we anticipate a data read-out towards the end of the first quarter of 2020.”