Achieve Life Sciences Announces Completion of Last Subject, Last Follow-Up Visit in Phase 3 ORCA-2 Trial of Cytisinicline for Smoking Cessation
05 January 2022 - 12:30AM
Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage
pharmaceutical company committed to the global development and
commercialization of cytisinicline for smoking cessation and
nicotine addiction, today announced that the last study follow-up
visit for the last subject enrolled in the ORCA-2 Phase 3 trial
occurred in late December 2021.
The ORCA-2 trial is the first Phase 3 trial in Achieve's ORCA
(Ongoing Research of
Cytisinicline for Addiction)
Program, designed to evaluate the smoking cessation effectiveness,
safety, and tolerability of 3 mg cytisinicline taken three times
daily (TID) for either 6 or 12 weeks, compared with placebo.
Subjects in the trial received standard behavioral support
during treatment and while completing follow-up assessments through
24 weeks post randomization. ORCA-2 randomized 810 subjects across
17 clinical trial sites in the United States. Topline data
regarding the primary results are expected in the second quarter of
2022.
"Completion of the follow-up phase in the ORCA-2 trial
represents another significant milestone in our cytisinicline
development pipeline,” commented Dr. Cindy Jacobs, President and
Chief Medical Officer of Achieve. “We look forward to sharing
topline data from the study in the coming months and continuing to
move our pipeline forward through initiation of enrollment in the
ORCA-3 and ORCA-V1 trials in 2022.”
Achieve’s second cytisinicline Phase 3 registrational clinical
trial, ORCA-3, is expected to initiate enrollment of approximately
750 adult cigarette smokers in the first quarter of 2022. The
grant-funded Phase 2 ORCA-V1 study, investigating the efficacy of
cytisinicline in approximately 150 adult nicotine e-cigarette
users, is expected to initiate by the end of the second quarter of
2022, dependent on grant funding timelines.
About Achieve and
Cytisinicline Tobacco use is currently the leading
cause of preventable death that is responsible for more than eight
million deaths worldwide and nearly half a million deaths in the
United States annually.1,2 More than 87% of lung cancer deaths, 61%
of all pulmonary disease deaths, and 32% of all deaths from
coronary heart disease are attributable to smoking and exposure to
secondhand smoke.2 Achieve’s focus is to address the global smoking
health and nicotine addiction 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.
Cytisinicline is an investigational product candidate being
developed for treatment of nicotine addiction and has not been
approved by the Food and Drug Administration for any indication in
the United States. For more information on cytisinicline and
Achieve, visit www.achievelifesciences.com.
Forward Looking StatementsThis 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 and nature of cytisinicline clinical development, data
results and commercialization activities, the potential market size
for cytisinicline, the potential benefits, safety and tolerability
of cytisinicline, the ability to discover and develop new uses for
cytisinicline, including but not limited to as an e-cigarette
cessation product, and the development and effectiveness of new
treatments. 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; risks related to the impact on our business of
the COVID-19 pandemic or similar public health crises 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.
References 1 World Health Organization.
WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World
Health Organization, 2017.
2 U.S. Department of Health and Human Services. The
Health Consequences of Smoking – 50 Years of Progress. A Report of
the Surgeon General, 2014.
Investor Relations Contact
Rich Cockrell
achv@cg.capital
(404) 736-3838
Media Contact
Glenn Silver
Glenn.Silver@Finnpartners.com
(646) 871-8485
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