Cytisinicline demonstrated quit rates at least as
effective as varenicline
Participants on cytisinicline experienced significantly
fewer side effects than those on varenicline
SEATTLE and VANCOUVER, BC,
June 29, 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 the successful
topline results from the New Zealand RAUORA Phase 3 non-inferiority
clinical trial comparing cytisinicline to varenicline (Chantix®) in
Māori (indigenous New Zealanders) and whānau (family) of Māori. The
study was led by Dr. Natalie Walker,
Associate Professor at the University of Auckland, and was funded by the Health
Research Council of New
Zealand.
The RAUORA trial was designed to evaluate the effectiveness,
safety, and cost-effectiveness of cytisinicline compared to
varenicline as a smoking cessation aid. In total, the study
randomized 679 subjects to receive 12 weeks of either cytisinicline
or varenicline. The primary endpoint was a comparison of
biochemically confirmed continuous abstinence rates at 6 months,
and the trial was designed to assess if the two agents were
non-inferior to each other. The trial achieved statistical
significance in showing that cytisinicline plus behavioral support
was at least as effective as varenicline plus behavioral support at
six months. In addition, the trial showed that cytisinicline
resulted in significantly fewer reported adverse events when
compared to varenicline. The final RAUORA trial results have been
submitted for presentation at The Society for Research on Nicotine
and Tobacco Europe (SRNT-E) Annual Meeting in September 2020.
"The positive topline results of the RAUORA Phase 3 trial, which
is the first, direct head-to-head comparative study between
cytisinicline and varenicline, provide additional evidence that
cytisinicline is at least as effective as varenicline while
offering improved tolerability," said Rick
Stewart, Chairman and Chief Executive Officer of Achieve.
"Importantly, these benefits were achieved using a lower dose of
cytisinicline. Future cytisinicline clinical trials, sponsored by
Achieve, will use a higher dose and optimized dosing schedule, and
we believe that this change will allow us to demonstrate even
better efficacy than what was seen in the RAUORA trial."
"In an effort to achieve New
Zealand's Smokefree 2025 goal, smoking rates need to
decrease substantially, particularly for Māori and their family,
who have the highest prevalence of smoking and the slowest decline
in prevalence over the last 20 years," said Dr. Natalie Walker, Associate Professor at the
University of Auckland and
Principal investigator for the RAUORA trial. "We found that
cytisinicline was just as good as Chantix in helping people to quit
smoking and stay quit. In addition, we found that fewer
people in the cytisinicline group reported any side
effects from the medicine compared to those in the Chantix
group. These results demonstrated that the study was
successful."
"We look forward to seeing the publication of full results from
this important study which will add to the growing body of clinical
evidence supporting cystisinicline's potential as a new tool in the
fight against smoking and nicotine addiction. We expect that 2020
will continue to be a pivotal year for our company as we continue
to publish new data and expect to initiate our Phase 3 U.S. trial
of cytisinicline later this year," added Stewart.
About the RAUORA Study
The RAUORA study was conducted
by the researchers at the University of Auckland, in conjunction with the Health
Economics Research Group (HERG) at Brunel University London, and
Lakes District Health Board. Currently, 3 in 10 Māori smoke, three
times more than non-Māori, and supporting this population to quit
smoking is a priority of the New
Zealand government. The study compared cytisinicline
administered on a schedule of 25 days of downward dosing titration
followed by twice-daily dosing for a total of 12 weeks with
varenicline administered on a schedule of 7 days of upward
titration followed by twice-daily dosing for a total of 12 weeks.
The primary endpoint was continuous abstinence from smoking for 6
months post-quit date.
In total, 1,105 Māori or whānau (Māori extended family members)
expressed interest in participating in the study and a total of 679
were randomized to receive either cytisinicline or varenicline. The
average age of participants in the trial was 43 years and
approximately 70% of the participants were women. Contact was
sought over a period of six to 12 months to collect data and
support their quit journey.
About Achieve and Cytisinicline
Tobacco use is
currently the leading cause of preventable death and is responsible
for more than eight million deaths annually worldwide1.
It is estimated that 28.7% of cancer deaths in the U.S. are
attributable to cigarette smoking2. 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.
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 potential 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 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.
Media
Contact
Glenn Silver
Email: Glenn.Silver@Finnpartners.com
Telephone: 1 646 871 8485
® Chantix® is a registered
trademark of Pfizer Inc.
1 World Health Organization. WHO Report on the
Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017
2 Annals of Epidemiology, Volume 25, Issue 3, 179 -
182.e1
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SOURCE Achieve Life Sciences, Inc.
