BOTHELL, Wash. and VANCOUVER, British Columbia, Aug. 16, 2017 /PRNewswire/ -- Achieve Life
Sciences, Inc. (NASDAQ: ACHV), a clinical-stage pharmaceutical
company committed to the global development and commercialization
of cytisine for smoking cessation, today announced initiation of
the Cytisine Clinical Development Program.
Cytisine 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 over 2,000 patients in
investigator-conducted, Phase 3 clinical trials in Europe and New
Zealand.
In preparation to initiate a pivotal Phase 3 trial in
the United States, Achieve expects
to conduct the following clinical studies in 2017:
- Evaluation of the effect of food on the bioavailability of
cytisine - enrollment has started, the first subjects have been
dosed and data analysis expected to be completed in Q4 2017.
- Assessment of repeat-dose pharmacokinetic (PK) parameters and
pharmacodynamics (PD) - expected to commence in Q4 2017.
"In the last month Achieve has announced the closing of our
merger with OncoGenex and subsequent listing on NASDAQ, the FDA
acceptance of Achieve's cytisine IND, and now the initiation of the
cytisine clinical development program," said Rick Stewart, Chairman and CEO of Achieve. "We
are focused on achieving our milestones with our primary goal of
initiating a U.S. pivotal Phase 3 trial next year."
About Cytisine
Achieve's focus is to address the global smoking health epidemic
through the development and commercialization of cytisine. Smoking
is currently the leading cause of preventable death and is
responsible for nearly six million people losing their lives
annually worldwide.
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. 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.
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 Achieve may not be
able to obtain additional financing to fund the development of
cytisine; 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.