Auris Medical Holding - Interim AM-201 data
Auris has announced interim data from its 50-subject AM-201 Phase Ib trial for olanzapine-induced weight gain and somnolence. The drug demonstrated safety and tolerability and provided initial signals of efficacy (limitations of the trial in terms of size and duration hamper its ability to provide definitive evidence). In the female study subjects, who showed more pronounced changes than the male study subjects, AM-201 demonstrated a 1.1kg benefit versus placebo over four weeks in those who received the highest dose (20mg three times daily). The company is now proceeding to a final dose level of 30mg in 30 healthy volunteers, with data expected around the end of Q120.
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