HAMILTON, Bermuda, Feb. 23, 2016 /PRNewswire/ -- Axovant Sciences Ltd. (NYSE: AXON), a leading clinical-stage biopharmaceutical company focused on the treatment of dementia, today announced that the company will be presenting at the Cowen and Company 36th Annual Health Care Conference on March 8 at 9:20 a.m. EST.
Axovant's management team will present an overview of its dementia drug development pipeline which includes the Company's global, multi-center, double-blind, placebo-controlled confirmatory Phase 3 study of RVT-101 for the treatment of mild-to-moderate Alzheimer's disease called the MINDSET Study and details of three new clinical trials to address cognitive, behavioral and functional aspects of Lewy body dementia, a disease affecting approximately 1.4 million people in the U.S.
The new studies include the HEADWAY-DLB trial, a Phase 2b, double-blind, placebo-controlled study of RVT-101 in subjects with dementia with Lewy bodies and two Phase 2 studies of nelotanserin. The nelotanserin studies include a pilot program in patients with dementia with Lewy bodies or Parkinson's disease dementia suffering from visual hallucinations and a study in patients with dementia with Lewy bodies suffering from REM behavior disorder.
A simultaneous webcast can be accessed by visiting the Investors section of www.axovant.com and selecting Events and Presentations. A replay will be available for 30 days following the conference.
Axovant Sciences Ltd. is a leading clinical-stage biopharmaceutical company focused on acquiring, developing and commercializing novel therapeutics for the treatment of dementia. Axovant intends to develop a pipeline of product candidates to comprehensively address the cognitive, functional and behavioral components of dementia and related neurological disorders. Our vision is to become the leading company focused on the treatment of dementia by addressing all forms and aspects of the disease.
MINDSET is a Phase 3 international, multi-center, double-blind, placebo-controlled clinical study designed to evaluate the safety, tolerability and efficacy of RVT-101 in patients with mild-to-moderate Alzheimer's disease. The 24-week trial will compare 35 mg, once-daily oral doses of RVT-101 to placebo in approximately 1,150 patients with mild-to-moderate Alzheimer's disease on a stable background of donepezil therapy. The primary efficacy evaluations are the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) and the Alzheimer's Disease Cooperative Study - Activities of Daily Living scale (ADCS-ADL), each of which have been used as endpoints to obtain regulatory approval of currently-marketed Alzheimer's disease treatments in the United States and Europe.
The MINDSET trial is designed to confirm the results of a 684-patient Phase 2 international, multi-center, double-blind placebo-controlled study in which patients on a stable background of donepezil therapy receiving 35 mg of RVT-101 were observed to have statistically significant improvements in their ADAS-cog and ADCS-ADL scores as compared to patients receiving donepezil alone.
HEADWAY-DLB is a Phase 2b international, multi-center, double-blind, placebo-controlled clinical study designed to evaluate the safety, tolerability and efficacy of RVT-101 in patients with dementia with Lewy bodies. The 24-week trial will compare 70 mg once-daily oral doses of RVT-101 to 35 mg once-daily oral doses of RVT-101 to placebo in subjects with dementia with Lewy bodies with or without existing background therapies. The primary efficacy evaluations are Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus) and a computerized cognitive battery.
SOURCE Axovant Sciences Ltd.