SEATTLE and VANCOUVER, BC, Sept.
18, 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
presentation of final results from the RAUORA trial, led by Dr.
Natalie Walker, Associate Professor
at the University of Auckland.
RAUORA evaluated the effectiveness and safety of cytisinicline
compared to varenicline as a smoking cessation aid in 679
indigenous New Zealanders (Māori) or their extended family, (337 in
the cytisinicline arm, 342 in the varenicline arm). Results were
presented today at the Society for Research on Nicotine and Tobacco
European (SRNT-E) Annual Meeting.
The primary endpoint of the non-inferiority trial was to
demonstrate that cytisinicline quit rates would be no less than 10%
lower than the quit rates for varenicline. Results showed that
cytisinicline met the pre-specified non-inferiority endpoint and
was trending towards superiority with an Absolute Risk Difference
of +4.29 in favor of cytisinicline (95% CI -0.22 to 8.79),
demonstrating a 4.29% improvement in quit rates in favor of
cytisinicline. Specifically, continuous abstinence rates at 6
months, verified by exhaled carbon monoxide, were 12.1% for
cytisinicline compared to 7.9% for varenicline. The Relative Risk
was 1.55 on an intent-to-treat basis, indicating that subjects in
the cytisinicline arm were approximately one and a half times more
likely to have quit smoking at 6 months compared to subjects who
Additionally, significantly fewer overall adverse events (AEs)
were reported in cytisinicline-treated subjects (Relative Risk
0.56, 95% CI 0.49 to 0.65, p<0.001). Notably, of the subjects
who experienced adverse events (111 in the cytisinicline arm
compared to 138 in the varenicline arm), there was significantly
less nausea (22.5% vs. 39.1%) and vivid dreams (7.2% vs. 17.4%)
"In this trial, subjects who received cytisinicline were on
average 55% more likely to quit smoking and about half as likely to
experience adverse events," said Cindy
Jacobs, Chief Medical Officer of Achieve. "Adverse events
can often lead to poor compliance, discontinuation of treatment,
and worse quit rates. The safety profile in RAUORA confirms what we
have seen historically, that cytisinicline continues to demonstrate
lower AEs, in particular, reduced nausea, which is the most
commonly reported AE for varenicline."
"It has been over a decade since the launch of Chantix and there
still remain over 34 million smokers in the U.S. alone. New,
effective treatments, such as cytisinicline, that offer improved
tolerability are desperately needed to help the millions of people
who are addicted to nicotine," commented Richard Stewart, Chairman and Chief Executive
Officer of Achieve. "Importantly, the benefits observed in the
RAUORA study were achieved using a lower dose of cytisinicline in a
difficult-to-treat patient population. We expect to demonstrate
even more impressive efficacy in the upcoming Phase 3 ORCA-2 trial,
that will utilize our 3 mg dose and optimized dosing schedule."
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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 1.5mg 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.
The trial demonstrated 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.
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 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 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.
Investor Relations Contact
(415) 375-3340 ext. 4
Chantix® is a registered trademark of Pfizer
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 -
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SOURCE Achieve Life Sciences, Inc.