SEATTLE and VANCOUVER, British Columbia, Sept. 13, 2019 /CNW/ -- Achieve Life
Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical
company committed to the global development and commercialization
of cytisinicline for smoking cessation, today announced that
two presentations featuring final data from the Phase 2b ORCA-1 trial will be conducted at the SRNT-E
Annual Conference on Friday, September
13th in Oslo.
ORCA-1 was designed to evaluate cytisinicline efficacy and
safety across various dosing and administration schedules in 254
smokers in the United States.
Topline results, reported in June of 2019, have led to the
selection of 3.0 mg, three times daily (TID) dosing for future
Phase 3 development.
The 3.0 mg TID treatment arm demonstrated a 54% abstinence rate
at week 4, compared to 16% for placebo (p < 0.0001) and a 4-week
continuous abstinence rate, weeks 5 through 8, of 30% for
cytisinicline compared to 8% for placebo (p= 0.005). Continuous
abstinence for 4 weeks is the relevant endpoint for regulatory
approval.
Final data included in the oral presentations at SRNT-E indicate
statistically significant end-of-treatment abstinence rates of
50-54% for all cytisinicline treatment arms compared to 16% for
placebo. Subjects had smoked on average for over 30 years. There
were no differences observed in treatment outcomes based on subject
demographics, clinical site location, number of prior smoking
cessation treatments, or previous quit attempts.
Overall adherence to study treatment was greater than 94% across
all treatment arms and 98% in the 3.0 mg TID arm,
specifically. Cytisinicline was well-tolerated with no serious or
severe adverse events (AEs) reported. Overall, in subjects treated
with cytisinicline, all individual AE's reported were below a rate
of 10%. Minimal rates of abnormal dreams, insomnia, upper
respiratory tract infections, and nausea were reported compared
with placebo.
Achieve Life Sciences will host an investor day with smoking
cessation opinion leaders on Friday,
September 20, 2019 in New York
City to further review and discuss the outcomes of the
ORCA-1 trial. The Investor Day will start at 12PM ET and will be 2 hours in duration. This is
an RSVP-only event open to members of the investment community.
Additional details and registration information is available at the
Achieve website,
http://ir.achievelifesciences.com/events-and-webcasts.
Additional information on cytisinicline and the ORCA program can
be found at www.achievelifesciences.com and
www.orcaprogram.com.
About Cytisinicline
Tobacco use is currently
the leading cause of preventable death and is responsible for
nearly seven 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 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.
About ORCA-1
ORCA-1 is the first in Achieve's ORCA
(Ongoing Research of Cytisinicline for
Addiction) Program, which aims to evaluate the safety and
effectiveness of cytisinicline for smoking cessation and
potentially other addiction indications. The study was designed to
evaluate the declining titration schedule, currently utilized in
Central and Eastern Europe,
compared to a simplified TID schedule at both the 1.5 mg and 3 mg
cytisinicline doses compared to placebo. ORCA-1 topline results
were announced in June 2019 and
enrolled 254 smokers at eight centers across the United States.
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, statements regarding the planned
cytisinicline clinical development activities, the timing of
clinical development activities related to cytisinicline, 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; 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 law.
Achieve Contact
Jason Wong
jwong@bplifescience.com
(415) 375-3340 ext. 4
"ORCA is a trademark of Achieve Life Sciences, Inc."
1 World Health Organization. WHO Report on the Global
Tobacco Epidemic, 2017. 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.