BASEL, Switzerland,
June 19, 2017 /PRNewswire/ -- Axovant
Sciences (NYSE: AXON) today announced that the U.S. Food and Drug
Administration (FDA) has granted Fast Track designation to its
investigational drug nelotanserin for the treatment of visual
hallucinations disorder in dementia with Lewy bodies (DLB).
Dementia with Lewy bodies is the second-leading form of
progressive dementia and affects over 1 million people in
the United States. Currently,
there are no approved therapies for the disease in the United States or in Europe.
"We are pleased that the FDA has granted nelotanserin Fast Track
designation," said David Hung, M.D.,
chief executive officer of Axovant. "Patients in the United States with DLB who experience
frequent visual hallucinations have no approved treatment options
and we hope to work closely with the FDA as we seek to address the
needs of this underserved patient population as quickly and
efficiently as possible."
Nelotanserin is a novel 5HT2A inverse agonist being
investigated in a Phase 2 double-blind, randomized,
placebo-controlled crossover safety study involving more than 20
subjects diagnosed with Lewy body dementia who experience frequent
visual hallucinations. In addition, nelotanserin is being
investigated in a Phase 2 double-blind, randomized,
placebo-controlled study involving up to 60 subjects diagnosed with
Lewy body dementia who have REM sleep disorder.
Fast Track designation is a process designed to facilitate the
development, and expedite the review, of important new drugs to
treat serious conditions which fill unmet medical needs in order to
get them to patients earlier. Early and frequent communications
between the FDA and the sponsor throughout the drug development and
review process help ensure that questions are resolved quickly,
often leading to earlier drug approval.
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 late- and early-stage 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 Statement
This press release contains
forward-looking statements, including statements regarding
Axovant's expectations about timing of the results for the Phase 3
MINDSET study of intepirdine in patients with Alzheimer's disease,
the Phase 2b HEADWAY-DLB study of intepirdine in patients with DLB,
the Phase 2 gait and balance study, DLB and PDD, the Phase 2 study
of nelotanserin in patients with LBD suffering from visual
hallucinations, the Phase 2 study of nelotanserin in patients with
LBD suffering from RBD, the proof of concept and related studies of
RVT-103 and RVT-104 in patients with Alzheimer's disease and DLB,
and other elements of its clinical development 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 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. There can be no assurance that the clinical programs
for intepirdine, nelotanserin, RVT-103, or 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 annual report on Form 10-K filed with the
Securities and Exchange Commission on June
13, 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.
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SOURCE Axovant Sciences