3.0 mg, 3 times daily selected as dose for future clinical
development
SEATTLE and VANCOUVER, British Columbia, June 11, 2019 /CNW/ -- Achieve Life
Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical
company focused on nicotine addiction, today announced positive
results from the ORCA-1 dose-selection trial of cytisinicline for
smoking cessation. The outcome of the 254-subject, ORCA-1 trial is
the selection of 3.0 mg, three times daily (TID) for Phase 3
development.
The primary endpoint was the reduction in daily smoking, a
self-reported measure. Three of the four cytisinicline treatment
arms demonstrated a statistically significant improvement, as
defined in the protocol as p < 0.05, compared to placebo. The
fourth arm trended to significance (p= 0.052). Across all treatment
arms, over the 25-day treatment period, subjects on cytisinicline
experienced a 74-80% median reduction in the number of cigarettes
smoked, compared to a 62% reduction in the placebo arms.
The secondary endpoint of the trial was a 4-week continuous
abstinence rate, which is the relevant endpoint for regulatory
approval. Cytisinicline treatment showed significant improvements
in abstinence rates compared to placebo. The most impressive
results were observed in the 3 mg TID treatment arm which
demonstrated a 54% abstinence rate at week 4, compared to 16% for
placebo (p < 0.0001) and a continuous abstinence rate, weeks 5
through 8, of 30% for cytisinicline compared to 8% for placebo (p=
0.005).
All four cytisinicline arms demonstrated statistically
significant (p < 0.05) reductions in expired carbon monoxide
(CO), a biochemical measure of smoking activity. Expired CO levels
declined by a median of 71-80% in the cytisinicline treatment arms,
compared to only 38% in the placebo arms. The lack of consistency
in the reduction of expired CO levels compared to the self-reported
data suggest potential under-reporting of cigarettes smoked by
subjects on placebo.
"The robust efficacy results in the simplified, three times
daily dosing arms exceeded our expectations, particularly, the
statistically significant abstinence rates. This is of importance
given that a continuous abstinence rate is the endpoint for
regulatory approval in smoking cessation trials," said Rick Stewart, Chairman and CEO of Achieve. "In
addition to efficacy, the cytisinicline safety data observed in
ORCA-1 reflects the historically strong safety profile already
experienced in Central and Eastern
Europe."
Adherence to study treatment was greater than 98.5% across all
arms and cytisinicline was well-tolerated with no serious adverse
events reported. The most commonly reported (>5%) adverse events
(AEs) across all cytisinicline treatment arms versus placebo were
abnormal dreams, insomnia, upper respiratory tract infections, and
nausea. In the 3 mg TID treatment arm versus placebo, the most
common AEs were abnormal dreams, insomnia, and constipation (each
6% vs 2%), upper respiratory tract infections (6% vs 14%), and
nausea (6% vs 10%).
The Company expects to conduct further analyses of the ORCA-1
trial and submit data for presentation at a future medical meeting.
Additionally, Achieve plans to discuss the trial's outcome with the
FDA and finalize Phase 3 protocol details in the second-half of
2019.
Achieve would like to thank the investigators, healthcare
providers, and subjects whose commitment and efforts to ORCA-1 made
this trial a success. Additional information on cytisinicline and
the ORCA program can be found at www.achievelifesciences.com and
www.orcaprogram.com.
Conference Call Details
Achieve will host a conference
call at 8:30 a.m. Eastern time today,
Tuesday, June 11, 2019. 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) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and
referencing conference ID 6986745. A webcast replay will be
available approximately two hours after the call and will be
archived on the website for 90 days.
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. Subjects were provided
face-to-face behavioral support over the full course of the study.
Smoking abstinence was measured at week 4 (end-of-treatment).
Continuous abstinence was also measured at weeks 5 through 8
(end-of-study). Abstinence assessments were verified by expired
carbon monoxide (CO), a biochemical measure of smoking
activity.
The study was blinded to dosing. Demographics were similar
between schedules and for treatment arms in gender, age, years of
prior smoking, and number of previous quit attempts. At baseline,
subjects in the study reported smoking a median of 20 cigarettes
per day. ORCA-1 was initiated in October
2018 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.