SEATTLE and VANCOUVER, B.C., Oct.
7, 2020 /PRNewswire/ -- 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
initiation of the Phase 3 ORCA-2 clinical trial. ORCA-2 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 in the United States.
"We are very excited to be participating in this important trial
that will hopefully lead to a widely available new treatment option
for smokers in the U.S. and around the globe," commented
Nancy Rigotti, MD, Massachusetts
General Hospital, Professor of Medicine at Harvard Medical School, and Primary Investigator of
the ORCA-2 trial. "Smoking remains the number one cause of
preventable death and we clearly need new options to help people
who smoke avoid the enormous toll of illness and death attributable
to cigarette smoking."
ORCA-2 participants will be randomized to one of three study
arms to determine the smoking cessation efficacy and safety profile
of 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
- Arm C: 12 weeks of cytisinicline
The primary outcome measure of success in the ORCA-2 trial is
biochemically verified continuous abstinence during the last four
weeks of treatment in the 6 and 12-week cytisinicline treatment
arms compared to 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.
"We are optimistic that the ORCA-2 trial will add to the growing
body of evidence demonstrating that cytisinicline, if approved, can
be an effective and well-tolerated treatment for smokers who want
to quit," stated John Bencich, Chief
Executive Officer of Achieve. "Importantly, based on the findings
of ORCA-1 and modifications to the cytisinicline treatment regimen,
including a longer duration of treatment and a higher dose, we
believe ORCA-2 results may yield an improvement in quit rates
compared to previously reported data."
For additional information on cytisinicline and the ORCA-2
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 U.S. 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
As an approved, branded product in Central and Eastern Europe for more than two decades, it
is estimated that over 20 million people have used cytisinicline to
help combat nicotine addiction.
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, the timing and nature of
cytisinicline clinical development activities, the potential market
size for cytisinicline and the effectiveness and potential uses and
benefits of cytisinicline. 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 cytisinicline may
not be effective in treating a larger breadth of diseases and
addictions; 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; impacts from 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 Contact
(415) 375-3340 ext. 4
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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SOURCE Achieve Life Sciences, Inc.