BASEL, Switzerland,
Jan. 9, 2017 /PRNewswire/ -- Axovant
Sciences (NYSE: AXON), a leading clinical-stage
biopharmaceutical company focused on the treatment of dementia,
today announced updates that highlight recent advancement within
its clinical programs.
Pipeline Program Updates
- MINDSET trial recruitment: Axovant announced completion
of recruitment in the Phase 3 MINDSET study of intepirdine in
patients with mild-to-moderate Alzheimer's disease. The MINDSET
trial is being conducted pursuant to a Special Protocol Assessment
(SPA) agreement with the U.S. Food and Drug Administration
(FDA).
- Intepirdine Thorough QT (TQT) study: The results of the
TQT study exclude significant QT interval prolongation following a
supratherapeutic dose of intepirdine.
- Intepirdine and itraconazole drug-drug interaction
study: No clinically relevant drug-drug interactions were
observed between intepirdine and itraconazole, a potent inhibitor
of metabolic enzymes, in a group of healthy subjects.
- RVT-103 proof of concept study: Axovant recently
completed the first portion of a proof of concept study. In the
first portion of the study, subjects were randomized to treatment
with a single dose of donepezil and either placebo or a peripheral
muscarinic receptor antagonist. The company remains blinded to
these results. The second portion of this study has begun and will
explore multiday dosing of donepezil and either placebo or a
peripheral muscarinic receptor antagonist. The primary endpoint of
this study is safety.
Pipeline Programs
Axovant is developing intepirdine, nelotanserin, RVT-103, and
RVT-104 as potential treatments for patients with Alzheimer's
disease and Lewy body dementia. The company expects the following
top-line results from its ongoing clinical studies in 2017:
- MINDSET: Results from the MINDSET study in the third
quarter of 2017.
- HEADWAY-DLB: Results from the Phase 2b study of
intepirdine in patients with dementia with Lewy bodies, the
HEADWAY-DLB study, in the fourth quarter of 2017.
- Nelotanserin Phase 2 Visual Hallucinations Study:
Preliminary results from the first cohort of 10 patients with
Lewy Body dementia in February 2017. The company expects to present
additional data from all 20 patients in the study in the first half
of 2017.
- Nelotanserin Phase 2 REM Behavior Disorder Study:
Results from the Phase 2 study evaluating nelotanserin for
treatment of REM Behavior Disorder in patients with dementia with
Lewy bodies in the second half of 2017.
- Gait and Balance in Patients with Dementia Study:
Results from the Phase 2 study of the effects of intepirdine on
gait and balance in patients with Alzheimer's disease, dementia
with Lewy bodies, and Parkinson's disease dementia in 2017.
- RVT-103 Proof of Concept Study: Results from the RVT-103
program in the first half of 2017.
"2016 represented yet another year of major disappointments for
late-stage clinical trials in dementia," said Vivek Ramaswamy, Chief Executive Officer of
Axovant Sciences. "In 2017, Axovant expects results from five
different phase 2 and phase 3 programs for Alzheimer's disease and
Lewy body dementia, including results from the Phase 3 MINDSET
study. On behalf of the millions of patients in need of new
therapeutic options, we hope that 2017 represents a bright year for
major advances in the treatment of dementia."
Cash Balance as of December 31,
2016
Axovant estimates that its cash balance was
approximately $200.4 million as of
December 31, 2016.
J.P. Morgan Conference Presentation and Webcast
Axovant Sciences will be presenting at the 35th Annual J.P. Morgan
Healthcare Conference on January 10
at 12:00 p.m. PST.
A simultaneous webcast will be available in the Investors
section of Axovant's website at www.axovant.com. A replay will be
available for 30 days following the conference.
About Axovant Sciences
Axovant Sciences is a global
clinical-stage biopharmaceutical company focused on the development
and commercialization of novel therapeutics for the treatment of
dementia, including Alzheimer's disease and Lewy body dementia. Our
vision is to become the leading company focused on the treatment of
dementia by addressing all forms and aspects of this condition.
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 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 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.
Forward-Looking Statements
This press release contains
forward-looking statements, including statements regarding
Axovant's clinical development and regulatory strategy, including
for intepirdine, nelotanserin, RVT-103 and RVT-104. Forward-looking
statements can be identified by the words "believe," "anticipate,"
"continue", "estimate", "project," "expect," "plan," "potential,"
"intend," "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, nelotanserin, RVT-103 and RVT-104; 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, nelotanserin, RVT-103 and RVT-104 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