HAMILTON, Bermuda, Sept. 26, 2016 /PRNewswire/ -- Axovant
Sciences Ltd. (NYSE: AXON), a leading clinical-stage
biopharmaceutical company focused on the treatment of dementia,
today announced that the company has received Fast Track
designation for its Investigational New Drug (IND) application for
intepirdine in the treatment of dementia with Lewy bodies from the
U.S. Food and Drug Administration (FDA).
"We are pleased that FDA has placed a high priority on the
development of intepirdine as a potential treatment for dementia
with Lewy bodies," stated Dr. Lawrence
Friedhoff, Chief Development Officer of Axovant Sciences.
"Dementia with Lewy bodies is the second-leading form of
progressive dementia and affects over 1 million people in
the United States and currently
there are no approved treatments for the disease in either
the United States or Europe. We believe the HEADWAY-DLB study of
intepirdine in dementia with Lewy bodies represents an important
step to address the unmet need of patients with this
condition."
The ongoing HEADWAY-DLB study will evaluate over a 24-week
treatment period the efficacy, safety and tolerability of
intepirdine at doses of 70 mg and 35 mg daily in approximately 240
patients with dementia with Lewy bodies. The study permits patients
currently receiving stable background therapy for dementia with
Lewy bodies to participate.
The agency's Fast Track designation is a process designed to
facilitate the development, and expedite the review of drugs to
treat serious conditions and fill an unmet medical need. Once a
drug receives Fast Track designation, early and frequent
communication between the FDA and a drug company is encouraged
throughout the entire drug development and review process. The
frequency of communication assures that questions and issues are
resolved quickly, often leading to earlier drug approval and access
by patients.
More information about FDA' Fast Track designation is available
at the following address:
www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm
About Axovant
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 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.
About HEADWAY-DLB
HEADWAY-DLB is a Phase 2b
international, multi-center, double-blind, placebo-controlled
clinical study designed to evaluate the safety, tolerability and
efficacy of intepirdine in patients with dementia with Lewy bodies.
The 24-week trial will evaluate once-daily oral doses of 70 mg
intepirdine, 35 mg intepirdine, and placebo in subjects with
probable dementia with Lewy bodies. The primary efficacy
evaluations are Clinician's Interview-Based Impression of Change
Plus Caregiver Input (CIBIC-Plus) and a computerized cognitive
battery.
For more information, please visit www.lewybodystudy.com or
e-mail headwaydlb@axovant.com or call 646-677-5778.
Forward-Looking Statements
This press release contains
forward-looking statements, including statements regarding
Axovant's elements of its clinical development regarding
intepirdine and regulatory strategy. 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. There can be no assurance that the clinical programs
for intepirdine 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 August 15,
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.