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Axovant Unveils New Data Analysis Showing Addition of Intepirdine to Standard Therapy May Help People with Alzheimer's Disease Maintain Independence Longer
Date:12/9/2016

HAMILTON, Bermuda, Dec. 9, 2016 /PRNewswire/ -- Axovant Sciences Ltd. (NYSE: AXON), a leading clinical-stage biopharmaceutical company focused on the treatment of dementia, today announced a new analysis of the data from a Phase 2b trial evaluating treatment with intepirdine (RVT-101), combined with standard of care donepezil, compared with donepezil plus placebo in people with mild-to-moderate Alzheimer's disease. This analysis indicates that the addition of intepirdine to treatment was associated with reduced progression in dependence (as assessed by Dependence Level based on the Dependence Scale), suggesting that those in the study who received combination treatment spent more time in the earlier, less dependent stages of the disease. This analysis was presented in an oral session at the 2016 Clinical Trials in Alzheimer's Disease (CTAD) Meeting on Friday, December 9, 2016, in San Diego.

"Several studies have suggested that the Dependence Scale, which assesses the degree to which things must be done for a person with dementia, captures a combination of cognitive, functional, and psychiatric changes that occur in Alzheimer's disease," said co-author Yaakov Stern, PhD, Columbia University College of Physicians and Surgeons, Cognitive Neuroscience Division, Department of Neurology and Taub Institute. "Several reports in the literature document that the Dependence Scale not only correlates to changes in cognition and function but also closely relates to cost of care, is predictive of subsequent rate of decline, and is a concept that is readily understood and meaningful to clinicians, people with dementia, and their caregivers."

Intepirdine is Axovant's investigational 5-HT6 receptor antagonist in development as a potential treatment for people with Alzheimer's disease on a stable background of donepezil therapy. It is also in development as a potential treatment for dementia with Lewy Bodies.  Axovant has incorporated the Dependence Scale into the ongoing intepirdine trials in both Alzheimer's disease and dementia with Lewy bodies. Results from both trials are expected in 2017.

"Axovant is evaluating the effect of intepirdine on the core symptoms of dementia—cognition and function—using traditional scales, but we are also examining the overall impact of treatment on the Dependence Scale because maintaining independence is critically important to individuals and families affected by the disease," said Axovant Chief Development Officer Dr. Lawrence Friedhoff. "This analysis using a Dependence Scale analog indicates that patients on intepirdine had a lower rate of progression toward dependence at 24, 36, and 48 weeks and we look forward to evaluating this meaningful measure prospectively in our ongoing studies." 

About MINDSET

MINDSET is a Phase 3 international, multi-center, double-blind, placebo-controlled clinical study designed to evaluate the safety, tolerability, and efficacy of intepirdine in patients with mild-to-moderate Alzheimer's disease. The 24-week trial will compare 35 mg, once-daily oral doses of intepirdine to placebo in approximately 1,150 individuals 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 has been used as respective endpoints to obtain regulatory approval of currently-marketed Alzheimer's disease treatments in the United States and Europe.

The MINDSET trial is being conducted pursuant to a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).

The MINDSET trial is designed to confirm the results of a 684-patient Phase 2b international, multi-center, double-blind placebo-controlled study in which patients on a stable background of donepezil therapy receiving 35 mg of intepirdine were observed to have statistically significant improvements in their ADAS-cog and ADCS-ADL scores as compared to patients receiving donepezil alone.

About Axovant Sciences

Axovant Sciences 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 aspects 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 this condition.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding Axovant's clinical development and regulatory strategy, including for intepirdine. Forward-looking statements can be identified by the words "believe," "anticipate," "continue", "estimate", "project," "expect," "plan," "potential," "intends," "will," "would", "could", "should" or the negative or plural of these words or other similar expressions that are predictions or indicate future events, trends or prospects. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of our product development activities and clinical trials; the approval and commercialization of our product candidates intepirdine and nelotanserin; and increased regulatory requirements. These statements are subject to the risk that clinical trial data are subject to differing interpretations, and regulatory agencies, medical and scientific experts and others may not share Axovant's views of the clinical study data. The products discussed are investigational and not approved and there can be no assurance that the clinical programs for intepirdine or nelotanserin will be successful in demonstrating safety and/or efficacy, that we will not encounter problems or delays in clinical development, or that any of our product candidates will ever receive regulatory approval or be successfully commercialized. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Axovant's business in general, see the "Risk Factors" section of our quarterly report on Form 10-Q filed with the Securities and Exchange Commission on November 7, 2016, and other filings that Axovant makes with the SEC from time to time. These forward-looking statements are based on information available to Axovant as of the date of this press release and speak only as of the date of this release. Axovant disclaims any obligation to update these forward-looking statements, except as may be required by law.

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