RESULTS OF A PHASE 2 STUDY OF NELOTANSERIN, A NOVEL 5HT2A RECEPTOR INVERSE AGONIST, IN LEWY BODY DEMENTIA SUBJECTS EXPERIENCING VISUAL HALLUCINATIONS

Abstract

Lewy body dementia is a common neurodegenerative disorder that affects approximately 1.4 million individuals in the U.S. alone (Lewy Body Dementia Association). It includes two related disorders: dementia with Lewy bodies (DLB) and Parkinson's disease dementia (PDD). Visual hallucinations affect up to 80% of patients with DLB (Taylor 2011), while up to 75% of patients with PDD are affected by psychosis (Cummings 2014), a condition commonly characterized in this population by hallucinations. Nelotanserin is a selective 5HT2A receptor inverse agonist in development for the treatment of behavioral disturbances, including visual hallucinations, in patients with Lewy body dementia. Nelotanserin has been evaluated in nine completed clinical studies to date with approximately 800 subjects exposed to the drug candidate. This abstract presents data from a Phase 2 study of nelotanserin in DLB and PDD subjects experiencing visual hallucinations. This is a double-blind, randomized, placebo-controlled crossover study of nelotanserin in Lewy body dementia subjects who are experiencing visual hallucinations (ClinicalTrials.gov: NCT02640729). Subjects in the study must have DLB or PDD, frequent visual hallucinations, and a baseline MMSE score > 18. Subjects are randomized to one of two treatment sequences: nelotanserin in the first treatment period followed by placebo in the second treatment period, or vice versa. The primary outcome measures of the study are extrapyramidal signs as assessed by the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III, and safety. Secondary outcome measures include observational changes in the severity and frequency of visual hallucinations, including multiple subscales from the Scale for the Assessment of Positive Symptoms (SAPS). Results from the study will be presented at this conference. Nelotanserin is a novel 5HT2A inverse agonist in development for the treatment of visual hallucinations in patients with Lewy body dementia. This Phase 2 placebo-controlled study represents an initial effort to develop a new therapy for this significant unmet need. Nelotanserin is also being tested in a separate Phase 2 clinical trial in DLB patients with REM sleep behavior disorder.