Achieve Life Sciences Announces Initiation of the Phase 3 ORCA-3 Clinical Trial Evaluating Cytisinicline for Smoking Cessation
January 25 2022 - 7:00AM
Achieve Life Sciences, Inc. (NASDAQ: ACHV), a clinical-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
ORCA-3, the confirmatory Phase 3 trial required for registrational
approval of cytisinicline in the United States. ORCA-3 will
evaluate the efficacy and safety of 3 mg cytisinicline dosed 3
times daily compared to placebo in 750 adult smokers at 15 clinical
sites.
Similar to the first registrational Phase 3 ORCA-2 trial, ORCA-3
participants will be randomized to one of three study arms to
evaluate cytisinicline administered for either 6 or 12 weeks,
compared to placebo. All subjects will receive standard behavioral
support and will be assigned to one of the following groups:
- Arm A: 12 weeks of placebo
- Arm B: 6 weeks of cytisinicline,
followed by 6 weeks of placebo
- Arm C: 12 weeks of
cytisinicline
The primary outcome measure of success in the ORCA-3 trial 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 will be compared
independently to the placebo arm, and the trial will be determined
to be 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 6 months from the start of study treatment.
“With the kickoff of the ORCA-3 trial, upcoming topline data
results from ORCA-2, and the anticipated initiation of the ORCA-V1
e-cigarette cessation trial, we believe 2022 will be a pivotal year
for Achieve,” stated John Bencich, Chief Executive Officer of
Achieve. “We are grateful for the ORCA-3 investigators and the
trial’s future participants who are committed to quitting smoking
in the New Year.”
Achieve recently announced completion of the last subject visit
in the ongoing Phase 3 ORCA-2 trial, with topline data results
expected in the second quarter of 2022. Additionally, the
grant-funded Phase 2 ORCA-V1 study, which is expected to
investigate the efficacy of cytisinicline in approximately 150
adult nicotine e-cigarette users, is anticipated to initiate by the
end of the second quarter of 2022, subject to grant funding
timelines.
For additional information on cytisinicline and the ORCA-3
trial, visit achievelifesciences.com or orcaprogram.com.
About Achieve and 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 Achieve’s focus is to address the global smoking
health and nicotine addiction epidemic through the development and
commercialization of cytisinicline.
Cytisinicline is a plant-based alkaloid with a high binding
affinity to the nicotinic acetylcholine receptor. It is believed to
aid in smoking cessation by interacting with nicotine receptors in
the brain by reducing the severity of nicotine withdrawal symptoms
and by reducing the reward and satisfaction associated with
smoking.
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 Statements This 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 Contact Rich
Cockrell achv@cg.capital (404) 736-3838
Media Contact Glenn
Silver Glenn.Silver@Finnpartners.com (646) 871-8485
References 1 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.
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