SEATTLE and VANCOUVER, British Columbia, Feb. 20, 2019 /PRNewswire/ -- Achieve Life
Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical
company committed to the global development and commercialization
of cytisinicline for smoking cessation, today announced the
completion of full enrollment in the ORCA-1 trial of cytisinicline.
ORCA-1 is the first in Achieve's ORCA (Ongoing
Research of Cytisinicline for Addiction)
Program, which aims to evaluate the effectiveness of cytisinicline
for smoking cessation and potentially other addiction
indications.
The Phase 2b trial is evaluating a
25-day treatment course of 1.5 mg or 3.0 mg doses of
cytisinicline using either a declining titration schedule or three
times daily dosing. The trial is randomized and blinded to compare
the effectiveness of the cytisinicline doses and schedules to
respective placebo groups. The primary efficacy endpoint is the
overall reduction in the number of cigarettes smoked during the
treatment period, with secondary analyses being conducted on
smoking cessation rates, safety, and compliance. Smokers who are
participating in the trial receive standardized behavioral
support.
ORCA-1 was initiated in October
2018 and enrolled 254 smokers at eight centers across
the United States. The trial's
Data Safety Monitoring Committee met recently and concluded there
are no safety concerns for subjects and the trial should continue
as planned. ORCA-1 topline efficacy and safety data are expected to
be announced in mid-2019.
"Progress on the cytisinicline development program is rapid and
Achieve is grateful to the investigators and study participants for
their swift enrollment and commitment to the ORCA-1 trial," said
Dr. Cindy Jacobs, Chief Medical
Officer at Achieve. "We look forward to sharing the data results in
the near future, which will serve to inform our Phase 3 development
program."
Additional information on cytisinicline and the ORCA program can
be found at www.achievelifesciences.com and
www.orcaprogram.com.
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."
1World 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.