SEATTLE and VANCOUVER, British Columbia, Dec. 9, 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 and nicotine addiction, today announced
an update on the cytisinicline clinical development program.
Following discussions with the Food and Drug Administration
(FDA), Achieve has received feedback on the final Phase 3 clinical
trial protocols and the cytisinicline clinical development program.
Specifically, the FDA has agreed with the overall Phase 3 study
designs that will utilize the simplified cytisinicline dosing
schedule of 3.0 mg administered three times daily and the duration
of 6 and 12 weeks of treatment. The FDA also agreed that the use of
the newly-developed, single 3.0 mg cytisinicline tablet in the
Phase 3 program was acceptable.
Minimal changes to the Phase 3 protocol were discussed and
agreed upon by both Achieve and the FDA. No changes were required
for the primary and secondary analyses. Achieve agreed to complete
a second chronic toxicology study supporting the 12 weeks of
treatment prior to initiating the Phase 3 program. The chronic
toxicology study report is expected to be available and submitted
to the FDA in the first quarter of 2020.
The FDA agreed that no further escalation in cytisinicline
dosing beyond the 30.0 mg dose was necessary for defining a maximum
tolerated dose, which is required for the New Drug Application
"We are extremely appreciative of the collaborative and
successful discussions with the FDA at the meeting and look forward
to submitting the final non-clinical requirements and initiating
the Phase 3 program in the first half of 2020," commented Dr.
Cindy Jacobs, Chief Medical Officer
Achieve previously announced results of the Phase 2b ORCA-1 trial evaluating cytisinicline efficacy
and safety across various dosing and administration schedules in
254 smokers in the United States.
Topline results demonstrated a 54% abstinence rate at week 4 in the
3.0 mg three times daily (TID) cytisinicline arm compared to 16%
for placebo (p < 0.0001). Additionally, for the 3.0 mg TID
cytisinicline arm, a 4-week continuous abstinence rate, weeks 5
through 8, of 30% for cytisinicline was observed compared to 8% for
placebo (p= 0.005). Continuous abstinence for 4 weeks is the
relevant endpoint for regulatory approval and will be the primary
endpoint in the planned Phase 3 trials.
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 generally well-tolerated with no serious or
severe adverse events (AEs) reported. Overall, in subjects treated
with cytisinicline, all individual AEs reported were below a rate
of 10%. Minimal rates of abnormal dreams, insomnia, upper
respiratory tract infections, and nausea were reported compared
Achieve plans to initiate the Phase 3 development program in
2020, subject to the availability of capital. Additional
information on cytisinicline and the ORCA program can be found at
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 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
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.
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.
(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, 2019. Geneva:
World Health Organization, 2017
2 Annals of Epidemiology, Volume 25, Issue 3, 179 -
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SOURCE Achieve Life Sciences, Inc.