HAMILTON, Bermuda, Dec. 5, 2016 /PRNewswire/ -- Axovant Sciences
Ltd. (NYSE: AXON), a leading clinical-stage biopharmaceutical
company focused on the treatment of dementia, today announced that
data on the investigational use of intepirdine for the treatment of
Alzheimer's disease will be presented at the 2016 Clinical Trials
in Alzheimer's Disease (CTAD) Meeting on Friday, December 9, 2016 in San Diego. Intepirdine presentations at CTAD
will show results of both simple and complex measures of activities
of daily living (ADLs) and overall functional dependence –
important indicators of treatment benefit.
"The continued ability to independently perform everyday tasks
such as making meals and doing laundry is critical to the overall
well-being of individuals and families affected by Alzheimer's
disease," said Axovant Chief Development Officer Dr. Lawrence Friedhoff. "Axovant is currently
evaluating the effectiveness of intepirdine on the core symptoms of
dementia, cognition and function, in our MINDSET trial. In addition
to using traditional scales, we are also examining the overall
impact of treatment using a more specific scale, called the
Dependence Scale, which measures a person's ability to maintain
their independence. We will be presenting an analysis from our
Phase 2b trial related to this topic for the first time at
CTAD."
Intepirdine is an investigational 5-HT6 receptor antagonist in
development as a potential treatment for individuals 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.
Intepirdine Function and Independence Data
Presentations
Oral Presentation: December 9,
2016, 12:15 p.m. PST
- "An Assessment of Dependence Level Progression Using a
Conversion Algorithm of ADCS-ADL to Dependence Scale and Data From
a Double Blind Placebo Controlled Trial of Intepirdine
(RVT-101)"
Poster Presentations: December 9,
2016, 12:30 p.m. to 1:30 p.m.
PST
- "The Efficacy of Intepirdine (RVT-101), a 5-HT6 Receptor
Antagonist, as an Adjunct to Donepezil in Adults with
Mild-to-Moderate Alzheimer's Disease: Completer Analysis of a Phase
2b Study"
- "Intepirdine (RVT-101) as an Adjunct to Donepezil in Adults
with Mild-to-Moderate Alzheimer's Disease: ADCS-ADL Subscale
Analyses"
In addition, Axovant will make an oral presentation on
December 9, 2016 at 8:15 a.m. PST titled "Drug Interaction between
Intepirdine (RVT-101), a 5-HT6 Receptor Antagonist, and Memantine
in Healthy Subjects."
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, including
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, including those 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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SOURCE Axovant Sciences Ltd.