Nelotanserin misses REM sleep behavior disorder trial endpoint

A trial of a treatment for REM sleep behavior disorder failed to meet its main goal, said Switzerland-based biotech firm Axovant Sciences (Nasdaq; AXON), whose shares plummeted 27.49% to $1.24 by close of trading yesterday following the announcement.

Axovant, a Roivant Sciences company, reported top-line results of the 34-patient, exploratory Phase II clinical study of nelotanserin for the treatment of REM sleep behavior disorder (RBD) in patients with Lewy body dementia (LBD). The primary efficacy endpoint of reduction in frequency of RBD events as measured by sleep laboratory video assessment was not met.

Nelotanserin was generally well-tolerated in the study. Signals of efficacy were observed on secondary measures, including trends in pre-specified analyses of study diaries and certain sleep parameters on polysomnography (PSG). These findings are consistent with nelotanserin’s mechanism of action and previous clinical studies of nelotanserin in patients with insomnia.