Strategic Collaboration with the National Institutes of
Health (NIH) Instrumental in Facilitating IND-enabling
Studies
BOTHELL, Wash. and VANCOUVER, British Columbia, Aug. 10, 2017 /PRNewswire/ -- Achieve Life
Sciences, Inc. (NASDAQ: ACHV) today announced that the U.S. Food
and Drug Administration (FDA) has accepted the Investigational New
Drug (IND) application for cytisine, an established smoking
cessation treatment that has been approved and marketed in
Central and Eastern Europe for more than 15 years. The
company is now authorized to proceed with clinical development of
cytisine in the U.S.
Cytisine is a plant-based alkaloid with a high binding affinity
to the nicotinic acetylcholine receptor. It is estimated that
over 20 million people have used cytisine to help combat nicotine
addiction, including approximately 2,100 patients in Phase 3
clinical trials conducted in Europe and New
Zealand. Achieve expects to commence a Phase 3 trial of
cytisine in the United States in
the first-half of 2018.
"FDA acceptance of the cytisine IND represents a significant
milestone for Achieve, providing further validation of our
objective to obtain FDA approval for cytisine and bring this
important therapy to people battling nicotine and tobacco
addiction," said Rick Stewart,
Chairman and CEO of Achieve. "We are extremely grateful for the
support and commitment we have received from the National
Institutes of Health (NIH), which has sponsored a number of
non-clinical studies to enable our IND submission."
According to the U.S. Surgeon General's 2014 report¹ "The Health
Consequences of Smoking - 50 years of Progress", there are more
than 16 million Americans living with diseases caused by smoking
and it is responsible for more than 480,000 deaths per year. The
report states that productivity losses from premature death exceed
$150 billion per year and the annual
costs of direct medical care of adults attributable to smoking are
estimated to be over $130
billion.
"Given the burden of smoking-related illnesses, cytisine could
be a potential drug of public health importance. NCCIH efforts in
collaboration with the NIH Blueprint Neurotherapeutics Network, and
the National Cancer Institute Developmental Therapeutics
Program, have contributed to our understanding of cytisine's
safety profile, which is needed for clinical development.
With further clinical testing, if cytisine is approved by the FDA,
another smoking cessation option would be available to help reduce
the number of lives lost due to tobacco smoking and nicotine
addiction," said David Shurtleff,
Ph.D., NCCIH deputy director.
Two prior, large-scale Phase 3 clinical studies of cytisine,
with favorable outcomes, have been successfully completed in over
2,000 patients. The TASC trial was a 740 patient, double-blind,
placebo controlled trial conceived by Professor Robert West at University College London and
funded by the U.K. National Prevention Research Initiative. The
CASCAID trial was a 1,310 patient, single-blind, non-inferiority
trial comparing cytisine to nicotine replacement therapy (NRT). The
CASCAID trial was conceived by Dr. Natalie
Walker, National Institute for Health Innovation, University
of Auckland and funded by the
Health Research Council of New
Zealand. Both trials were published in the New England
Journal of Medicine.
References:
1.
https://www.surgeongeneral.gov/library/reports/50-years-of-progress/exec-summary.pdf
About Achieve and Cytisine
Achieve is developing
cytisine as a smoking cessation aid. Cytisine is a plant-based
alkaloid with a high binding affinity to the nicotinic
acetylcholine receptor. It is an established smoking cessation
treatment that has been approved and marketed in Central and Eastern
Europe for more than 15 years. It is estimated that over 20
million people have used cytisine to help combat nicotine
addiction, including approximately 2,000 patients in Phase 3
clinical trials conducted in Europe and New
Zealand. Achieve's focus is to address the global smoking
health epidemic, which is currently the leading cause of
preventable death and is responsible for nearly six million people
losing their lives annually worldwide. Discussions have been held
with FDA and European regulatory agencies to determine the clinical
and regulatory pathway towards making cytisine widely
available.
Forward Looking Statements
This press release contains forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995, including, but not limited to,
statements regarding the timing of clinical development of
cytisine, the market size for cytisine and the potential benefits
of cytisine. All statements other than statements of historical
fact are statements that could be deemed forward-looking
statements. Achieve may not actually achieve its plans or product
development goals in a timely manner, if at all, or otherwise carry
out its intentions or meet its expectations or projections
disclosed in these forward-looking statements. These statements are
based on management's current expectations and beliefs and are
subject to a number of risks, uncertainties and assumptions that
could cause actual results to differ materially from those
described in the forward-looking statements, including, among
others, the risk that cytisine may not demonstrate the hypothesized
or expected benefits; the risk that cytisine will not receive
regulatory approval or be successfully commercialized; the risk
that new developments in the smoking cessation landscape require
changes in business strategy or clinical development plans; the
risk that Achieve's intellectual property may not be adequately
protected; general business and economic conditions; and the other
factors described in the risk factors set forth in Achieve's
filings with the Securities and Exchange Commission from time to
time, including the final Proxy Statement/Prospectus/Information
Statement filed pursuant to Rule 424(b)(3) in connection with
Achieve's recent merger, and Achieve's Annual Reports on Form 10-K
and Quarterly Reports on Form 10-Q. Achieve undertakes no
obligation to update the forward-looking statements contained
herein or to reflect events or circumstances occurring after the
date hereof, other than as may be required by applicable law.
Achieve
Contact
Hershel Berry
hberry@bplifescience.com
(415) 375-3340 ext. 1
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SOURCE Achieve Life Sciences, Inc.