Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage
pharmaceutical company committed to the global development and
commercialization of cytisinicline for smoking cessation and
nicotine dependence, today announced positive topline results from
the Phase 3 ORCA-3 trial of cytisinicline. Consistent with the
previously reported Phase 3 ORCA-2 study, ORCA-3 showed a
statistically significant benefit in helping people to quit smoking
compared to placebo, with low rates of adverse events.
ORCA-3 was designed to evaluate the efficacy and safety of 3mg
cytisinicline dosed 3 times daily for a period of 6 weeks or 12
weeks compared to placebo. ORCA-3 randomized 792 adult smokers at
20 clinical trial sites in the United States. All participants
received standard behavioral support for the duration of the trial.
The primary endpoint for ORCA-3 was biochemically verified smoking
cessation measured during the last 4 weeks of treatment. Subjects
were monitored for smoking cessation for 24 weeks post
randomization.
Both the 6- and 12-week cytisinicline treatment durations
demonstrated statistically significant smoking cessation on both
the primary and secondary efficacy analyses compared to
placebo.
12-Week Cytisinicline Efficacy Results
- Primary Endpoint: Subjects who
received 12 weeks of cytisinicline treatment had 4.4 times higher
odds, or likelihood, to have quit smoking during the last 4 weeks
of treatment compared to subjects who received placebo
(p<0.0001). The smoking cessation rate during weeks 9 through 12
was 30.3% for cytisinicline compared to 9.4% for placebo.
- Secondary Endpoint: The continuous
smoking cessation rate from week 9 to week 24 was 20.5% for the
12-week cytisinicline arm compared to 4.2% for placebo, with an
odds ratio of 5.79 (p<0.0001).
6-Week Cytisinicline Efficacy Results
- Primary Endpoint: Subjects who
received 6 weeks of cytisinicline treatment had 2.85 times higher
odds, or likelihood, to have quit smoking during the last 4 weeks
of treatment compared to subjects who received placebo (p=0.0008).
The smoking cessation rate during weeks 3 through 6 was 14.8% for
cytisinicline compared to 6% for placebo.
- Secondary Endpoint: The continuous
smoking cessation rate from week 3 to week 24 was 6.8% for the
6-week cytisinicline arm compared to 1.1% for placebo, with an odds
ratio of 6.25 (p=0.0006).
ORCA-3 subjects had an average age of 53 years, smoked a median
of 20 cigarettes per day at baseline, and had a median smoking
history of 36 years with 4 prior quit attempts.
Similar to ORCA-2 findings, cytisinicline was well-tolerated
with no treatment-related serious adverse events reported. The most
commonly reported (>5% overall) adverse events for placebo,
6-week cytisinicline, and 12-week cytisinicline were:
- Insomnia: (7.6%, 11.0%, 11.9%)
- Abnormal dreams: (5.7%, 9.1%, 7.7%)
- Nausea (7.3%, 9.5%, 6.9%)
- Headache (6.1%, 7.6%, 8.5%)
“The ORCA-3 study findings add to a large body of evidence
showing that cytisinicline appears to be a very well-tolerated and
effective treatment compared to behavioral support alone for people
who are dependent on cigarettes and want to quit,” said Dr. Omer
Abid, Board Certified Addiction Medicine Physician & Medical
Director of Insight Behavioral Health, Principal Investigator at
Insight Research Institute, and ORCA-3 Investigator. “Cytisinicline
gives hope for future smoking cessation success, given that there
are limited available treatments, and many have tolerability
limitations that lead to lack of compliance or
adoption.”
The health consequences of smoking are widely known, yet the use
of combustible nicotine cigarettes continues to be a global health
issue. There are an estimated 28.3 million adults in the United
States, and more than 1 billion people globally that currently
smoke. Smoking remains the leading cause of preventable death and
disease and claims the lives of an estimated 8 million people
worldwide each year. If approved, cytisinicline could be the first
new prescription treatment in nearly 20 years to help the millions
of people who smoke to overcome nicotine dependence.
“Following the success of our previous clinical trials, and
years of research, we are thrilled with the results from this
second and confirmatory Phase 3 study of cytisinicline. With more
than 2,000 clinical trial participants in our ORCA program to date,
we are confident that cytisinicline has the potential to help the
millions of people who are battling nicotine dependence,” said John
Bencich, Chief Executive Officer of Achieve Life Sciences. “We
would like to extend our gratitude to the ORCA-3 trial
participants, the healthcare providers, and to everyone who
continues to support Achieve’s mission of helping people live
better and healthier lives. We are excited about the future and
continuing our work with regulators with the aim of bringing
cytisinicline to market.”
Conference Call DetailsAchieve will host a
conference call at 8:30 AM EDT today, Tuesday, May 23, 2023. To
access the webcast and the accompanying data presentation, visit
the investor relations page of the Achieve website at
http://ir.achievelifesciences.com/events-and-webcasts.
Alternatively, access to the live conference call is available by
dialing (877) 269-7756 (U.S. & Canada) or (201) 689-7817
(International) and referencing conference ID 13739070. A webcast
replay will be available approximately two hours after the call and
will be archived on the website for 90 days.
Further information on cytisinicline and Achieve Life Sciences
can be found at www.achievelifesciences.com.
About ORCA-3The Phase 3 ORCA-3 trial evaluated
792 adults who smoked cigarettes on a daily basis at 20 clinical
trial locations in the United States. The trial was initiated in
January 2022 and completed enrollment in September 2022, with
topline results reported in May 2023. ORCA-3 participants received
3mg cytisinicline dosed 3 times daily for either 6 or 12 weeks and
were monitored through 24 weeks post randomization. The trial was
blinded, placebo-controlled, and all subjects received behavioral
support for the duration of the trial. The primary endpoint was
biochemically verified continuous abstinence during the last four
weeks of treatment. Secondary outcome measures assessed continued
abstinence rates through 6 months from the start of study
treatment.
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 over 11 million adults in the United
States who use e-cigarettes, also known as vaping.3 In 2022,
approximately 2.5 million middle and high school students in the
United States reported using e-cigarettes.4 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 the treatment of nicotine addiction and has not been
approved by the Food and Drug Administration for any indication in
the United States.
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
macroeconomic conditions, including inflation, rising interest
rates, instability in the global banking sector, and public health
crises, such as 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 ContactNicole
Jonesachv@cg.capital(404) 736-3838
Media ContactGlenn
SilverGlenn.Silver@Finnpartners.com(646) 871-8485
References 1World 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, Loretan CG, Jamal A,
et al. Tobacco Product Use Among Adults — United States, 2021. MMWR
Morb Mortal Wkly Rep 2023;72:475–483.4Park Lee E, Ren C, Cooper M,
Cornelius M, Jamal A, Cullen KA. Tobacco Product Use Among Middle
and High School Students – United States, 2022. Morbidity and
Mortality Weekly Report, 2022; 71:45.
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