Axovant Sciences Ltd. (NYSE:AXON) Files An 8-K Other EventsItem 8.01 Other Events.
Axovant has submitted a final protocol with statistical analysis plan to the U.S Food and Drug Administration that designates the Unified Parkinson Disease Rating Scale – Part III (UPDRS-III) as the primary efficacy endpoint, and the Alzheimer’s Disease Assessment Scale-Cognitive subscale (ADAS-Cog) and Clinician’s Interview-Based Impression of Change plus Caregiver Input (CIBIC+) as co-secondary endpoints for the Phase 2b HEADWAY study of its investigational drug intepirdine in patients with dementia with Lewy bodies. Previously, the primary efficacy evaluations were the Clinician’s Interview-Based Impression of Change plus Caregiver Input (CIBIC+) and a computerized cognitive battery.
About Axovant Sciences Ltd. (NYSE:AXON)
Axovant Sciences Ltd., formerly Roivant Neurosciences Ltd., is a clinical-stage biopharmaceutical company focused on acquiring, developing and commercializing therapeutics for the treatment of dementia. The Company focuses on developing a pipeline of product candidates to address the cognitive, functional and behavioral aspects of dementia and related neurological disorders. The Company’s focus is to develop its lead product candidate, Intepirdine, which is a selective 5-hydroxytryptamine 6 (5-HT6) receptor antagonist for the treatment of Alzheimer’s disease and dementia with Lewy bodies (DLB). The Company also focuses on developing its second product candidate, Nelotanserin, which is a selective 5-HT2A receptor inverse agonist for the treatment of visual hallucinations in patients with DLB and rapid eye movement (REM) behavior disorder (RBD) in patients with DLB.