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 target enrollment of 750
subjects has been reached in the Phase 3 ORCA-3 trial.
Similar to the previously reported ORCA-2 trial, ORCA-3 is
evaluating the smoking cessation efficacy, safety, and tolerability
of 3 mg cytisinicline dosed three times daily (TID) for either 6 or
12 weeks compared with placebo. ORCA-3 participants will be
monitored through 24 weeks post randomization and will receive
standard behavioral support for the duration of the trial. More
than 750 adult smokers have been randomized across 20 clinical
trial locations in the United States. Trial sites are no longer
enrolling new subjects, but those currently in screening will be
allowed to participate provided they meet entry criteria. Topline
results are expected to be reported in the first half of 2023.
“We are pleased to have completed enrollment in this second
confirmatory Phase 3 trial that we expect will fulfill the clinical
requirements for regulatory submission in the U.S., and ultimately,
if approved, enable cytisinicline availability to the millions of
American smokers who desperately need new treatment options to help
them overcome their nicotine addiction,” stated John Bencich, Chief
Executive Officer of Achieve. “We would like to extend our
gratitude to the ORCA-3 clinical research teams, and importantly,
the smokers who endeavored a quit attempt through participation in
this study. We wish them continued success on their quit
journey.”
In April 2022, Achieve announced positive, statistically
significant results in its Phase 3 ORCA-2 clinical trial of
cytisinicline in 810 adult smokers across 17 clinical trial
locations in the United States. ORCA-2 evaluated the efficacy and
safety of 3 mg of cytisinicline dosed three times daily for either
6 or 12 weeks compared to placebo in adult smokers. Both the
primary and secondary endpoints demonstrated increased quit rates,
showing 6-8 times increased odds of smoking abstinence when
compared to placebo. Cytisinicline was well tolerated with
single-digit rates of adverse events observed and no
treatment-related serious adverse events reported.
If approved by the U.S Food and Drug Administration, or FDA,
cytisinicline would be the first, non-nicotine smoking cessation
prescription treatment made available to American smokers in nearly
two decades.
For more information on cytisinicline or the ORCA-3 trial,
please visit www.achievelifesciences.com.
About ORCA-3The ORCA-3 trial is Achieve Life
Sciences’ second randomized Phase 3 trial evaluating the efficacy
and safety of cytisinicline as a treatment for smoking cessation in
adult smokers at 20 clinical trial locations in the United States.
Smokers were randomized to one-of-three treatment arms to receive
either placebo or 3 mg cytisinicline taken three times daily (TID)
for a period of either 6 or 12 weeks.
Similar to the ORCA-2 trial, which was the first randomized
Phase 3 clinical trial to show a smoking cessation benefit in
nearly two decades, the primary outcome measure of success in
ORCA-3 is biochemically verified continuous abstinence during the
last four weeks of treatment in the 6- and 12-week cytisinicline
treatment arms compared with placebo. Each treatment arm in the
trial will be compared independently to the placebo arm. The trial
will be deemed successful if either or both of the cytisinicline
treatment arms show a statistical benefit compared to placebo.
Secondary outcome measures will be conducted to assess continued
abstinence rates through six months from the start of study
treatment. ORCA-3 topline results are expected in the first half of
2023.
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
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, 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.
Investor Relations ContactRich
Cockrellachv@cg.capital(404) 736-3838
Media ContactGlenn
SilverGlenn.Silver@Finnpartners.com(646) 871-8485
References1World Health Organization. WHO
Report on the Global Tobacco Epidemic, 2019. Geneva: World Health
Organization, 2017.2U.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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