Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage clinical
pharmaceutical company committed to the global development and
commercialization of cytisinicline for smoking cessation and
nicotine addiction, today announced that it has been awarded $2.5
million in grant funding from the National Institute on Drug Abuse
(NIDA) of the National Institutes of Health (NIH) to evaluate the
use of cytisinicline as a treatment for cessation of nicotine
e-cigarette use.
This grant award will provide funding that enables Achieve to
initiate the Phase 2 ORCA-V1 clinical trial, which aims to evaluate
the efficacy and safety of cytisinicline in approximately 150 adult
nicotine e-cigarette users at 5 clinical trial locations in the
United States. Dr. Nancy Rigotti, Professor of Medicine at Harvard
Medical School and Director of the Tobacco Research and Treatment
Center at Massachusetts General Hospital, will be the Principal
Investigator of the trial.
“We are grateful for the continued partnership with the NIH that
has provided Achieve with non-dilutive funding that allows us to
proceed with ORCA-V1 trial initiation in the coming weeks,”
commented John Bencich, Chief Executive Officer of Achieve.
“Cytisinicline’s efficacy and tolerability observed in clinical
trials to date demonstrates its potential to help
nicotine-dependent people overcome their addiction. With more than
10 million users of nicotine e-cigarettes in the United States
alone, and no FDA-approved treatments available specifically for
this indication, we believe cytisinicline has the ability to help
meet the needs of this growing and underserved
population.”
In July 2021, an initial grant award of $320,000 was provided to
Achieve to complete critical regulatory and clinical operational
activities, including submission of a new IND to FDA for
investigating cytisinicline in nicotine e-cigarette users. In
total, $2.8 million has now been awarded under both the initial and
current grant awards from the NIH and is expected to cover
approximately half of the ORCA-V1 trial costs.
The use of e-cigarettes continues to be widespread, with the
most recent reports from the Centers for Disease Control and
Prevention indicating that there were nearly 11 million adult users
in the United States alone in 2019. In a survey conducted by
Achieve of 508 users of nicotine vaping devices or e-cigarettes,
approximately 73% of participants responded that they intend to
quit vaping within the next 3 to 12 months. Of those who intended
to quit even sooner, within the next 3 months, more than half
stated they would be extremely likely to try a new prescription
product to help them do so.
In addition to the upcoming ORCA-V1 trial evaluating
cytisinicline in nicotine e-cigarette users, Achieve is evaluating
smoking cessation of combustible cigarettes in its Phase 3 clinical
development program. The ORCA-2 clinical trial, comprised of 810
adult smokers, recently reported positive topline results. 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.2
In 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
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) 871-8485
References1 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, 2014.3Cornelius 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.mm6946a44Ogunwale, Mumiye A et al. (2017) Aldehyde
Detection in Electronic Cigarette Aerosols. ACS omega 2(3):
1207-1214. DOI: 10.1021/acsomega.6b00489].5Gentzke 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.ss7105a1.6Elizabeth 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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