Nelotanserin: Interim Ph II data

Interim data from 11 patients with Lewy body dementia or Parkinson's disease (PD) dementia who were experiencing frequent visual hallucinations in a double-blind, crossover, U.S. Phase II trial showed that once-daily oral nelotanserin met the primary endpoint of improving UPDRS Parts II and III scores from baseline to day 28 vs. placebo (p<0.05). Nelotanserin missed the secondary endpoints of improving the severity and frequency of visual hallucinations based on multiple subscales from SAPS -- an internally developed, diary-based measurement -- vs. placebo. No treatment-related serious adverse events were reported. Patients received placebo for 4 weeks or 40 mg nelotanserin for the first 2 weeks followed by 80 mg nelotanserin for 2 weeks, followed by a 4-week washout period before switching treatments. Axovant said it plans to expand enrollment in the trial beyond the original target of 20 patients, but declined to disclose a new target...