BASEL, Switzerland,
Sept. 26, 2017 /PRNewswire/
-- Axovant Sciences (NASDAQ: AXON) today announced that the
Phase 3 MINDSET clinical trial of its investigational drug
intepirdine in patients with mild to moderate Alzheimer's disease
(AD) who were receiving background donepezil therapy did not meet
its co-primary efficacy endpoints. At 24 weeks, patients treated
with 35 mg of intepirdine did not experience improvement in
cognition or in measures of activities of daily living as measured
by the Alzheimer's Disease Assessment Scale-Cognitive Subscale
(ADAS-Cog) and by the Alzheimer's Disease Cooperative
Study-Activities of Daily Living scale (ADCS-ADL), respectively,
compared to patients treated with placebo. In the study,
intepirdine was generally well tolerated.
After 24 weeks of treatment, change from baseline in cognition
was non-significantly improved in the intepirdine arm versus the
placebo arm (0.36 ADAS-Cog points; p-value = 0.22). In addition,
there was essentially no difference between the intepirdine and
placebo arms in change from baseline in activities of daily living
(0.09 ADCS-ADL points; p-value = 0.83). Of the endpoints analyzed
to date, the only endpoint in which any significant improvement was
seen in the intepirdine arm versus the placebo arm was in the first
key secondary endpoint, the Clinician Interview-Based Impression of
Change plus caregiver interview, or CIBIC+ (0.12 CIBIC+ points;
p-value = 0.02). The Company will work with investigators to
conclude the MINDSET open-label extension study.
"While we are deeply disappointed by these trial results, we
also are saddened for the millions of patients and families
impacted by Alzheimer's disease. However, we believe that the fight
against Alzheimer's and other important areas of unmet need in
neurology is too important to be derailed by this setback," said
David Hung, M.D., chief executive
officer of Axovant. "We are grateful to the investigators, patients
and caregivers who participated in this important trial and
supported us in this journey. Moreover, we remain committed to
advancing our pipeline, which includes our Phase 2b HEADWAY study
of intepirdine, and nelotanserin, our highly selective inverse
agonist of the 5-HT2A receptor in Phase 2 development,
both of which are being evaluated in patients with dementia with
Lewy bodies."
The HEADWAY trial studying intepirdine in patients with dementia
with Lewy bodies (DLB) remains on track to report topline results
at the end of 2017. This study investigates two doses of
intepirdine, 35 mg (the dose used in the MINDSET trial) and 70 mg,
a higher dose intended to engage both 5-HT6 and
5-HT2A receptors. Intepirdine has received Fast Track
designation from the U.S. Food and Drug Administration for the
treatment of DLB.
About MINDSET
The global, randomized, double-blind, placebo-controlled Phase 3
MINDSET trial evaluated the efficacy, safety and tolerability of
intepirdine in patients with mild to moderate AD on donepezil
therapy over 24 weeks. The trial compared once-daily oral doses of
intepirdine 35 mg to placebo in 1,315 patients ages 50 to 85. The
Mini-Mental State Examination (MMSE) score at baseline ranged from
10 to 26. Co-primary efficacy endpoints were ADAS-Cog and the
ADCS-ADL.
About Alzheimer's Disease
Alzheimer's disease (AD), the most common form of dementia, is a
chronic, progressive neurodegenerative disorder that worsens over
time. It is the fifth leading cause of death among people age 65
years and older in the United
States.[i] According to the Alzheimer's
Association, about 5.5 million people in the U.S. today are
affected by AD,[i] and that number could triple by
2050.[i] In addition to the suffering and devastating
effect on quality of life experienced by both patients and
caregivers, AD costs the U.S. approximately $259 billion annually.[i] No new
chemical entities for AD have been approved by the FDA since
2003.[ii]
About Intepirdine
Intepirdine is an oral, once-daily, investigational drug in
development for the treatment of mild to moderate AD and dementia
with Lewy bodies (DLB). A potent antagonist of the 5-HT6
receptor, intepirdine promotes the release of acetylcholine in the
brain. This neurotransmitter is believed to be critical for
alertness, memory, thought and judgment -- the key components of
cognition and function that are impaired in patients with dementia.
At higher doses, intepirdine also blocks the 5-HT2A
receptor, which is believed to play a role in the psychosis, REM
sleep behavior disorder and motor dysfunction seen in patients with
DLB.
Teleconference/Webcast Details
To participate in the live conference call today, September 26, at 8:00 a.m.
EDT, please dial (352) 672-9956 from the U.S.
and Canada or +1 (844) 842-5660 internationally, and use
the passcode 89218918. The live call is being webcast and can be
accessed on the "Events and Presentations" page of the "Investors"
section of the Company's website at http://investors.axovant.com. A
replay of the webcast will be available for 30 days following the
live event.
About Axovant Sciences
Axovant is a clinical-stage biopharmaceutical company focused on
developing and commercializing innovative medicines to broadly
address multiple forms of dementia and related neurological
disorders. Axovant is developing a pipeline of product candidates
that focuses on the cognitive, functional and behavioral aspects of
debilitating conditions such as Alzheimer's disease, Lewy body
dementia and other neurological disorders. For more information,
visit www.axovant.com.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements regarding Axovant's plans for the development
of its pipeline and completion of the MINDSET open-label extension
study, as well as the HEADWAY study. 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, increased regulatory requirements,
and interim results or other preliminary analyses do not ensure
that later or final results in a clinical trial or in related or
similar clinical trials will replicate those interim results. There
can be no assurance 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 (SEC) on August 7,
2017, 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.
Contacts:
Investors
Jonathan
Neely
jonathan.neely@axovant.com
Media
Brian Reid
W2O Group
breid@w2ogroup.com
402.875.0525
Samina Bari
Samina.bari@axovant.com
[i]
https://www.alz.org/documents_custom/2017-facts-and-figures.pdf
[i]
https://www.alz.org/documents_custom/2017-facts-and-figures.pdf
[i]
https://www.alz.org/documents_custom/2017-facts-and-figures.pdf
[i]
https://www.alz.org/documents_custom/2017-facts-and-figures.pdf
[ii]
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4095696/
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SOURCE Axovant Sciences