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 dependence, today announced publication of the ORCA-V1
trial results in the Journal of the American Medical Association
(JAMA) Internal Medicine. ORCA-V1 evaluated the efficacy and safety
of 3 mg cytisinicline dosed three times daily for 12 weeks compared
to placebo in 160 non-smoking adults who used e-cigarettes or
nicotine vapes and wanted to quit e-cigarettes. All participants
received behavioral support for vaping cessation.
As reported today, the ORCA-V1 trial demonstrated that
biochemically confirmed continuous vaping abstinence during the
last 4 weeks of treatment, the primary outcome measure, was
significantly higher for cytisinicline treatment compared to
placebo. For cytisinicline treatment compared to placebo, 31.8%
versus 15.1% of participants were abstinent during weeks 9 to 12,
and participants receiving cytisinicline treatment had 2.6 times
higher odds, or likelihood, to have quit vaping (odds ratio (OR)
2.64 [95% CI, 1.06-7.10]; P=.04)
A consistent trend in favor of cytisinicline was found across
the secondary endpoints, evaluating abstinence during and beyond
end of treatment. During the 12-week study treatment, the past
seven-day prevalence of vaping abstinence at each week was
consistently higher in the cytisinicline group than the placebo
group. Similarly, the mean biochemical cotinine levels were
consistently lower in the cytisinicline group than the placebo
group at each weekly visit during study treatment. Including a
four-week follow-up after treatment ended, continuous abstinence
from weeks 9 to 16 remained higher in the cytisinicline group than
the placebo group at 23.4% versus 13.2%, respectively (OR, 2.0;
[95% CI, 0.82-5.32]).
"Many people who use e-cigarettes want to quit but find it
difficult due to nicotine dependence. They need help to stop
vaping, yet no FDA-approved medication is currently available to
help them do so," said Dr. Nancy Rigotti, Director, Tobacco
Research and Treatment Center Massachusetts General Hospital,
Professor of Medicine at Harvard Medical School, and Principal
Investigator of ORCA-V1. "Cytisinicline has been shown in clinical
trials to be effective and safe to help adults stop smoking
cigarettes. The results of this study indicate that it might also
help people to quit vaping."
Study drug compliance was high; 72.7% and 66.0% of participants
treated with cytisinicline and placebo, respectively, took >90%
of study drug doses. Cytisinicline was well tolerated and no
serious adverse events were reported. Similar rates of adverse
events were observed between treatment arms (50.9% in the
cytisinicline arm versus 54.7% in the placebo arm). The most
frequent (>5%) treatment-emergent adverse events for
cytisinicline subjects were sleep disturbances, anxiety, headache,
fatigue, and upper respiratory tract infection and for placebo
subjects were nausea, COVID-19, headache, anxiety and upper
respiratory tract infection. Higher rates of headache and nausea
were reported by participants treated with placebo.
“As we’ve seen now in multiple clinical trials, the safety and
tolerability profile of cytisinicline is very compelling and we
believe it will be a key driver of compliance when approved for
use,” commented Cindy Jacobs, MD, PhD, President and Chief Medical
Officer at Achieve. “Many people who attempt to quit nicotine
struggle with withdrawal symptoms and cravings, making it difficult
to maintain abstinence. Current treatments can have high rates of
headaches and nausea, and we are simply not seeing that with
cytisinicline, giving us confidence that cytisinicline’s profile
will help more people, who want to quit, succeed in doing so.”
The prevalence of e-cigarette use by adults in the United States
continues to rise. It is estimated that 4.5% among all adults in
the United States and 11% among adults aged 18-24 used e-cigarettes
in 2021. While adults who switch from smoking combustible
cigarettes to using nicotine e-cigarettes reduce their
tobacco-related health risks, e-cigarettes products are not
harmless and sustain nicotine dependence. In surveys, more than
half of adults who vape nicotine plan to quit. Cytisinicline, if
approved, could be the first prescription drug to help people who
are ready to address their addiction to e-cigarettes. Achieve plans
to conduct an End-of-Phase 2 Meeting with the FDA later this year
to discuss future clinical trial requirements to pursue an
indication for vaping cessation.
The research and clinical study discussed in this press release
was supported in part by the National Institute on Drug Abuse of
the National Institutes of Health (NIH) under Award Number
4R44DA054784-02. The content of this press release is the sole
responsibility of the authors and does not necessarily represent
the official views of the NIH.
About ORCA-V1The Phase 2 ORCA-V1 trial
evaluated 160 adults who used e-cigarettes on a daily basis at five
clinical trial locations in the United States. ORCA-V1 participants
were randomized to receive 3mg cytisinicline three times daily or
placebo for 12 weeks in combination with standard cessation
behavioral support. The dose and administration of cytisinicline in
the ORCA-V1 study is identical to that used in the Phase 3
registrational trials for smoking cessation. ORCA-V1 was supported
in part by the National Institute on Drug Abuse (NIDA) of the NIH
through grant funding which was awarded in two phases totaling $2.8
million.
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. There are an estimated 28 million adults in the
United States alone who smoke combustible cigarettes.1 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.2,3 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.3
In addition, there are over 11 million adults in the United
States who use e-cigarettes, also known as vaping.1 In 2023,
approximately 2.1 million middle and high school students in the
United States reported using e-cigarettes.4 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 the 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 and
regulatory review and approval, data results and commercialization
activities, the potential market size for cytisinicline, the
potential benefits, efficacy, 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
macroeconomic and geopolitical conditions, including inflation,
rising interest rates, increased volatility in the debt and equity
markets, actual or perceived instability in the global banking
system, global health crises and pandemics and geopolitical
conflict 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 ContactNicole
Jonesachv@cg.capital(404) 736-3838
Media ContactGlenn
SilverGlenn.Silver@Finnpartners.com(646) 871-8485
References1Cornelius ME, Loretan CG, Jamal A,
et al. Tobacco Product Use Among Adults – United States, 2021. MMWR
Morb Mortal Wkly Rep 2023;72:475–483.2World Health Organization.
WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World
Health Organization, 2017.3U.S. Department of Health and Human
Services. The Health Consequences of Smoking – 50 Years of
Progress. A Report of the Surgeon General, 2014.4Birdsey J,
Cornelius M, Jamal A, et al. Tobacco Product Use Among U.S. Middle
and High School Students — National Youth Tobacco Survey, 2023.
MMWR Morb Mortal Wkly Rep 2023;72:1173–1182.
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