Achieve Life Sciences Announces Data from Cytisinicline ORCA-V1 Program to be Presented at Society of General Internal Medicine (SGIM) Annual Meeting
May 17 2024 - 8:00AM
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 data from the Phase 2 ORCA-V1
vaping cessation trial will be presented today, Friday, May 17,
2024, at the Society of General Internal Medicine (SGIM) Annual
Meeting being held in Boston, MA.
Dr. Nancy Rigotti, ORCA-V1 Principal Investigator and Professor
of Medicine at Harvard Medical School, and Director of the Tobacco
Research and Treatment Center at Massachusetts General Hospital,
will present data from the Phase 2 ORCA-V1 trial. This study
explored the efficacy and safety of cytisinicline in adult smokers
seeking to quit nicotine e-cigarettes. In the study, treatment with
cytisinicline more than doubled the likelihood of quitting compared
to placebo.
“We are honored to have the ORCA-V1 findings presented at the
SGIM Annual Meeting as we believe this audience of healthcare
providers plays a vital role in helping people who battle with
nicotine dependence in its various forms,” stated Cindy Jacobs, MD,
PhD, President and Chief Medical Officer at Achieve Life Sciences.
“Cytisinicline has shown promising data in aiding smoking
cessation, has been well tolerated, and we believe it will be key
in helping people quit vaping as well.”
Dr. Rigotti’s presentation will be included in the “SAN2:
Scientific Abstract Oral Presentations in Mental/Behavioral Health
and Substance Use” session today, Friday, May 17, at 2:45 PM
EDT.
The research and clinical study discussed in this press release
was supported by the National Institute on Drug Abuse 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 NIH.
About ORCA-V1The Phase 2 ORCA-V1 trial
evaluated 160 adults who used e-cigarettes on a daily basis at 5
clinical trial locations in the United States. ORCA-V1 participants
were randomized to receive 3 mg 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
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.
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 conditions, including inflation, rising interest
rates, instability in the global banking sector, and public health
crises, such as the COVID-19 pandemic 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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