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 reported positive topline results from
its Phase 2 ORCA-V1 trial. ORCA-V1 evaluated the efficacy and
safety of 3mg cytisinicline dosed three times daily for 12 weeks
compared to placebo in 160 adults who use e-cigarettes or nicotine
vapes and who do not currently smoke cigarettes. All participants
received behavioral support for nicotine cessation.
The primary endpoint for ORCA-V1 was biochemically verified
continuous abstinence from nicotine e-cigarette use, measured
during the last 4 weeks of treatment. Subjects who received 12
weeks of cytisinicline treatment had 2.6 times higher odds, or
likelihood, to have quit vaping during the last 4 weeks of
treatment compared to subjects who received placebo (p=0.035). The
vaping cessation rate during weeks 9-12 was 31.8% for cytisinicline
compared to 15.1% for placebo. A benefit in favor of cytisinicline
was consistently observed across the secondary endpoints.
Additionally, a cessation benefit was observed for cytisinicline
across clinical trial sites and participant demographics such as
age, gender, race, or whether they had smoked cigarettes in the
past.
“These groundbreaking results from ORCA-V1 reaffirm our
confidence that cytisinicline could be a safe and effective option
to treat nicotine dependence,” said Dr. Cindy Jacobs, Chief Medical
Officer and President at Achieve Life Sciences. “We believe that
cytisinicline has the potential to become the first treatment for
nicotine vaping cessation, offering new hope to those who want to
quit e-cigarettes.”
Cytisinicline was well tolerated and no serious adverse events
were reported. Similar rates of adverse events (AE’s) were observed
between treatment arms (54.7% in the placebo arm vs. 50.9% in the
cytisinicline arm). The most commonly reported (>5%) AEs in the
placebo arm were anxiety, headache, upper respiratory tract
infection, nausea, and COVID-19 infection. In the cytisinicline
arm, >5% AEs reported were sleep disturbances, anxiety,
headache, fatigue, and upper respiratory tract infection.
ORCA-V1 participants had an average age of 34 years and were
engaged in current daily use of nicotine-containing e-cigarettes.
Approximately half of the participants had previously tried to quit
vaping by self-attempt methods. Subjects were stratified based on
past smoking history. Approximately 72% were former smokers of
combustible cigarettes, while 28% had not smoked cigarettes.
Efficacy results were similar for both groups. ORCA-V1 was
supported by the National Institute on Drug Abuse of the National
Institutes of Health.
“This new study suggests cytisinicline, which has previously
helped people to quit smoking cigarettes, may also help adults to
stop using e-cigarettes, another nicotine-containing product,” said
Dr. Nancy Rigotti, Professor of Medicine at Harvard Medical School,
and Principal Investigator of ORCA-V1.
Tobacco use continues to be a major health concern, with an
estimated 47 million adults in the United States using tobacco in
some form in 2020, including an estimated 9 million adults who used
e-cigarettes to vape nicotine. Many individuals have become
dependent on nicotine and want to quit but have difficulty in doing
so. No FDA-approved treatments have been specifically evaluated in
this population and the ORCA-V1 trial is the first randomized,
placebo-controlled clinical study to demonstrate successful
e-cigarette cessation.
In addition to the results of this study, Achieve Life Sciences
plans to announce topline results in the second quarter of 2023
from the Phase 3 ORCA-3 trial for cytisinicline as a new smoking
cessation treatment in people who want to quit daily cigarette
smoking but have not been able to do so using other available
treatments.
For more information on cytisinicline and Achieve visit
www.achievelifesciences.com.
Conference Call DetailsAchieve will host a
conference call at 8:30 AM EDT today, Thursday, April 20, 2023. To
access the webcast, log on to 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 13738334. A webcast
replay will be available approximately two hours after the call and
will be archived on the website for 90 days.
The research and clinical study discussed in this press release
is supported by the National Institute on Drug Abuse of the
National Institutes of Health (NIH) under Award Number
4R44DA054784-02. The content is the sole responsibility of the
authors and does not necessarily represent the official views of
the NIH.
About ORCA-V1 The Phase 2 ORCA-V1 trial
evaluated 160 adults who used e-cigarettes on a daily basis at 5
clinical trial locations in the United States. The trial was
initiated in June 2022 and completed enrollment in approximately 4
months, with topline results reported in April 2023. ORCA-V1
participants were randomized to receive 3mg cytisinicline three
times daily or placebo for 12 weeks in combination with standard
cessation behavioral support. The dose and administration of
cytisinicline in the ORCA-V1 study is identical to that used in the
Phase 3 registrational trials for smoking cessation. ORCA-V1 was
supported by the National Institute on Drug Abuse (NIDA) of the
National Institutes of Health (NIH) through grant funding which was
awarded in two phases totaling $2.8 million.
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 9 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, the development and effectiveness of new
treatments, and the intention to submit cytisinicline to the FDA
for approval. 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 Russian military action
in Ukraine; 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 ContactRich
Cockrellachv@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, Wang TW, Jamal A, Homa DM. Tobacco Product Use
Among Adults — United States, 2020. MMWR Morb Mortal Wkly Rep
2022;71:397–405. 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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