Achieve Life Sciences Announces Initiation of Phase 2 ORCA-V1 Clinical Trial Evaluating Cytisinicline for Nicotine e-cigarette Cessation
29 Juni 2022 - 2:00PM
Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage
pharmaceutical company committed to the global development and
commercialization of cytisinicline for smoking cessation and
nicotine addiction, today announced it has initiated screening of
subjects for the ORCA-V1 Phase 2 clinical trial.
ORCA-V1 will evaluate the efficacy and safety of
3mg cytisinicline dosed 3 times daily compared to placebo in
approximately 150 adult e-cigarette users at 5 clinical trial
locations in the United States. Participants will be
randomized to receive cytisinicline or placebo for 12 weeks in
combination with standard cessation behavioral support. ORCA-V1 is
being supported by the National Institute on Drug Abuse (NIDA) of
the National Institutes of Health (NIH) through grant funding which
was awarded in two phases totaling $2.8 million. During the first
phase, Achieve’s Investigational New Drug application for nicotine
e-cigarette cessation was reviewed and accepted by the U.S. Food
and Drug Administration (FDA) late last year.
“The initiation of the ORCA-V1 trial of
cytisinicline in e-cigarette users is yet another example of
honoring our commitment to deliver on key milestones and our
dedication to helping the millions of people who desire to overcome
their addiction to nicotine,” stated John Bencich, Chief Executive
Officer of Achieve. “We are appreciative of the partnership with
NIDA and NIH that is enabling this important research to be
conducted and to our clinical trial sites who are eager to begin
enrolling participants.”
In addition to the initiated ORCA-V1 trial, Achieve
is evaluating smoking cessation of combustible cigarettes in its
Phase 3 clinical development program. The ORCA-2 clinical trial,
which was comprised of 810 adult smokers, announced positive
topline results in April. Smokers who received cytisinicline in
ORCA-2 were up to 8 times more likely to have quit smoking compared
to those who received placebo. The ORCA-3 trial, the intended
confirmatory Phase 3 trial required for regulatory submission of
cytisinicline, is currently enrolling smokers at 15 clinical trial
locations in the United States. For additional information on
Achieve or the cytisinicline development program, visit
achievelifesciences.com or orcaprogram.com.
The planned research and clinical study discussed
in this press release is supported by the National Institute on
Drug Abuse (NIDA) of the National Institutes of Health (NIH) under
Award Number 4R44DA054784-02. The content is the sole
responsibility of the authors and does not necessarily represent
the official views of the National Institutes of Health.
About Achieve and
Cytisinicline Achieve’s focus is to address the global
smoking health and nicotine addiction epidemic through the
development and commercialization of 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.2In addition, there are
nearly 11 million adults in the United States who use e-cigarettes,
also known as vaping.3 While nicotine e-cigarettes are thought to
be less harmful than combustible cigarettes, they remain addictive
and can deliver harmful chemicals which can cause lung injury or
cardiovascular disease.4 In 2021, e-cigarettes were the most
commonly used tobacco product reported by 1.72 million high school
students.5 Research shows adolescents who have used e-cigarettes
are seven times more likely to become smokers one year later
compared to those who have never vaped.6 Currently, there are no
FDA-approved treatments indicated specifically as an aid to
nicotine e-cigarette cessation.
Cytisinicline is a plant-based alkaloid with a high
binding affinity to the nicotinic acetylcholine receptor. It is
believed to aid in treating nicotine addiction for smoking and
e-cigarette cessation by interacting with nicotine receptors in the
brain, reducing the severity of withdrawal symptoms, and reducing
the reward and satisfaction associated with nicotine products.
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,
the development and effectiveness of new treatments, and the
intention to submit cytisinicline to the FDA for approval. 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 Russian military action in
Ukraine; 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.Investor Relations
ContactRich Cockrellachv@cg.capital(404) 736-3838
Media ContactGlenn
SilverGlenn.Silver@Finnpartners.com(646)
871-8485References1 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, 2014.3 Cornelius ME, Wang TW, Jamal A,
Loretan CG, Neff LJ. Tobacco Product Use Among Adults — United
States, 2019. MMWR Morb Mortal Wkly Rep 2020;69:1736–1742. DOI:
10.15585/mmwr.mm6946a44 Ogunwale, Mumiye A et al. (2017)
Aldehyde Detection in Electronic Cigarette Aerosols. ACS omega
2(3): 1207-1214. DOI: 10.1021/acsomega.6b00489].5 Gentzke AS,
Wang TW, Cornelius M, et al. Tobacco Product Use and Associated
Factors Among Middle and High School Students – National Youth
Tobacco Survey, United States, 2021. MMWR Surveill Summ 2022;71(no.
SS-5):1-29. DOI: 10.15585/mmwr.ss7105a1.6 Elizabeth C. Hair,
Alexis A. Barton, Siobhan N. Perks, Jennifer Kreslake, Haijun Xiao,
Lindsay Pitzer, Adam M. Leventhal, Donna M. Vallone, Association
between e-cigarette use and future combustible cigarette use:
Evidence from a prospective cohort of youth and young adults,
2017–2019, Addictive Behaviors, Volume 112, 2021, 106593, ISSN
0306-4603. DOI: 10.1016/j.addbeh.2020.106593.
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