SEATTLE and VANCOUVER, British Columbia, Dec. 18, 2018 /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 provided a clinical
development update.
The U.S. Food and Drug Administration (FDA) has confirmed that
they are in agreement with Achieve's Initial Pediatric Study Plan,
specifically, providing a full waiver for evaluating cytisinicline
in a pediatric population. The reasons for the full waiver were
based on the low numbers of children smoking under the age of 12
and the logistical difficulties of recruiting treatment-seeking
smokers in the adolescent age group. The agreed Pediatric Study
Plan will be included as part of Achieve's future application for
marketing approval of cytisinicline.
The Company recently announced initiation of the first clinical
study in the ORCA (Ongoing Research of
Cytisinicline for Addiction) Program. ORCA-1 is a
Phase 2b optimization trial that is
currently enrolling 250 smokers at eight trial locations throughout
the United States. The trial is
evaluating various dosing schedules of cytisinicline and will
determine efficacy based on the overall reduction in the number of
cigarettes smoked during the various study treatment doses and
schedules. It will also compare smoking cessation rates,
compliance, and safety profiles, compared to the respective placebo
groups. ORCA-1 data results are expected in mid-2019.
Dr. Cindy Jacobs, Chief Medical
Officer at Achieve commented, "We are pleased with our recent
progress, specifically, initiating the ORCA-1 trial and reaching
agreement with FDA on our Pediatric Study Plan for a future market
application."
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 six million deaths annually worldwide1. It is
estimated that 28.6% of all 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, also known as
cytisine.
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, 2011, Geneva: World Health Organization, 2011.
2 Annals of Epidemiology, Volume 25 , Issue 3 , 179
- 182.e1
View original content to download
multimedia:http://www.prnewswire.com/news-releases/achieve-announces-update-on-cytisinicline-clinical-development-program-300767885.html
SOURCE Achieve Life Sciences, Inc.