SEATTLE and VANCOUVER, British Columbia, Feb. 22, 2019 /PRNewswire/ -- 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 final data
from their Phase I/II multi-dose, pharmacokinetic and
pharmacodynamics (PK/PD) clinical study of cytisinicline in
smokers. Study results will be presented today, Friday, February 22nd, at the Society
for Research on Nicotine & Tobacco (SRNT) Annual Meeting in
San Francisco.
The study evaluated the repeat-dose PK and PD effects of
1.5 mg and 3.0 mg cytisinicline in 26 healthy volunteer
smokers when administered over the standard 25-day course of
treatment. Smokers in the study had a mean age of 39 years, smoked
on average 17.2 cigarettes a day, and were not required to quit
smoking or have a predetermined quit date while on study. All
subjects had a significant and immediate reduction in cigarettes
smoked within 2 days of initiating cytisinicline treatment. By Day
26, subjects had an average 80% reduction in cigarettes smoked, 82%
reduction in expired carbon monoxide, and 46% had stopped smoking.
The biochemically verified smoking cessation rates were 39% and 54%
in the 1.5 mg and 3.0 mg cytisinicline treated groups,
respectively.
The PK results indicated expected increases in plasma
concentration between the standard 1.5 mg and higher
3.0 mg doses of cytisinicline with no evidence of drug
accumulation.
Cytisinicline at either dose was well tolerated with only
transient, mild-to-moderate headache as the most common adverse
event, which was not treatment limiting. No adverse events were
severe, serious, or led to withdrawal from the study.
Dr. Cindy Jacobs, Chief Medical
Officer at Achieve commented, "Given the short 25-day treatment
period, the abstinence rates observed are impressive, particularly
since subjects were not required to commit to quitting and received
minimal behavioral support during the study. These results continue
to support our belief that cytisinicline could be a well-tolerated
and effective potential treatment option for the millions of people
who are battling nicotine addiction."
Earlier this week, Achieve announced completion of enrollment in
the 254-subject Phase 2b ORCA-1 trial
evaluating various doses and schedules of cytisinicline. ORCA-1 is
the first in Achieve's ORCA (Ongoing Research of
Cytisinicline for Addiction) Program, which aims to
evaluate the effectiveness of cytisinicline for smoking cessation
and potentially other addiction indications. ORCA-1 topline
efficacy and safety data are expected to be announced in
mid-2019.
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.
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.