SEATTLE and VANCOUVER, British Columbia, July 23, 2019 /PRNewswire/ -- Achieve Life
Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical
company focused on nicotine addiction, today announced it has
extended its strategic collaboration with the National Center for
Complementary and Integrative Health (NCCIH) at the National
Institutes of Health (NIH). Under the extended collaboration, the
NIH is funding and providing research efforts to conduct additional
non-clinical studies as requested by the U.S. Food and Drug
Administration (FDA) to be included in the cytisinicline New Drug
Application (NDA).
"Given the research results to date, we are extending our
partnership with Achieve to aid in moving the science forward
regarding this approach for smoking cessation," said David Shurtleff, Ph.D., NCCIH Deputy Director.
"Smoking continues to be the leading cause of preventable death
around the world, and new treatment options have the potential to
complement existing evidence-based cessation strategies."
In discussions with the FDA in 2018, it was determined that a
Good Laboratory Practice (GLP) non-clinical reproductive study
would be required to support the NDA submission. NCCIH has agreed
to sponsor this study which is expected to complete in 2020.
Previously under the collaboration, the NCCIH sponsored the GLP
nonclinical studies that were required for the Investigational New
Drug (IND) application in order to initiate clinical studies. These
studies included genotoxicity testing, safety pharmacology, cardiac
conduction studies, pharmacokinetics, toxicokinetics, and the
required toxicology studies in two species. Combined fertility and
developmental studies were also conducted and co-sponsored by the
NCCIH and the National Cancer Institute (NCI) in preparation for
initiating the Phase 3 development program. In total, the NIH has
committed approximately $6 million
dollars to the development of cytisinicline.
About Cytisinicline
Tobacco use is currently the
leading cause of preventable death and is responsible for nearly
seven million deaths annually worldwide1. It is
estimated that 28.7% of cancer deaths in the U.S. are attributable
to cigarette smoking2. Achieve's focus is to address the
global smoking health epidemic through the development and
commercialization of cytisinicline.
Cytisinicline is a plant-based alkaloid with a high binding
affinity to the nicotinic acetylcholine receptor. It is believed to
aid in smoking cessation by interacting with nicotine receptors in
the brain by reducing the severity of nicotine withdrawal symptoms
and by reducing the reward and satisfaction associated with
smoking.
As an approved, branded product in Central and Eastern Europe for more than two decades, it
is estimated that over 20 million people have used cytisinicline to
help combat nicotine addiction.
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
planned cytisinicline clinical development activities, the timing
of clinical development activities related to cytisinicline, the
potential market size for cytisinicline and the potential benefits
of cytisinicline. 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 cytisinicline 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
cytisinicline; the risk that cytisinicline 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 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
Jason
Wong
jwong@bplifescience.com
(415) 375-3340 ext. 4
"ORCA is a trademark of Achieve Life Sciences, Inc."
1 World Health Organization. WHO Report on the
Global Tobacco Epidemic, 2017. Geneva: World Health Organization, 2017
2 Annals of Epidemiology , Volume 25 , Issue 3 ,
179 - 182.e1
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SOURCE Achieve Life Sciences, Inc.