SEATTLE and VANCOUVER, British Columbia, Sept. 30, 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
completion of their maximum tolerated dose (MTD) study. The results
indicate a lack of dose-limiting toxicity as defined by
protocol criteria even at the highest 30 mg single, oral dose of
cytisinicline evaluated in the study.
This study, initiated in March
2019, is required by the FDA as part of a New Drug
Application (NDA) for marketing approval in the United States. It was designed to
determine dose-limiting adverse events (AEs) and to define the
maximum tolerated dose for a single, oral dose of
cytisinicline.
An independent Data Safety Monitoring Committee (DSMC) composed
of the Study Investigator and two independent physicians evaluated
all safety outcomes before each dose escalation. Stopping criteria
for further dose escalation was defined as the occurrence of severe
or serious AEs or any other safety information considered as a
concern.
The starting dose was 6 mg, which increased in 3 mg
increments up to 21 mg. When the MTD was not reached at
21 mg, the study was amended to evaluate doses up to 30 mg. At
this dose, the stopping criteria of serious or severe AEs were
still not met, but the DSMC recommended stopping the study. The
results will be reviewed with the FDA to determine if further
escalation beyond 30 mg will be required.
"Cytisinicline continues to demonstrate an impressive safety
profile, as seen in this study and in our recently announced Phase
2b ORCA-1 trial in smokers," stated
Dr. Cindy Jacobs, Chief Medical
Officer of Achieve. "Side effects are often a key limitation to
existing smoking cessation treatments and we believe cytisinicline
continues to offer an improved tolerability profile, compared to
currently available medications."
The MTD has not been previously defined for cytisinicline. These
results do not impact the intended 3 mg, 3 times daily dosing
planned for future Phase 3 cytisinicline clinical trials, but
rather demonstrate the lack of dose-limiting toxicity at doses up
to 10 times higher than the planned 3 mg dose.
Additional information on cytisinicline 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 Cytisinicline MTD Study
The MTD study was a single-center, randomized,
placebo-controlled, single dose-escalation, Phase 1 clinical study
in adult smokers. The starting dose was 6 mg, which increased
in 3 mg increments up to 21 mg. Following the absence of
dose-limiting adverse events at 21 mg, the study was amended
to evaluate doses up to 30 mg of cytisinicline, as the highest dose
level of cytisinicline to be evaluated.
An independent Data Safety Monitoring Committee (DSMC) composed
of the Study Investigator and two independent physicians having
expertise in treating smoking cessation evaluated all safety
outcomes before each dose escalation. Stopping criteria for further
dose escalation was defined as any one of the following occurring:
severe or serious adverse events or any other safety information
considered as a concern. Pharmacokinetic parameters were also
assessed at each dose level.
While the stopping criteria of serious or severe adverse events
were not met at the 30 mg dose, the DSMC indicated the frequency of
gastrointestinal symptoms were approaching a maximum tolerated
dose. Additionally, by the final dosing cohort, the
pharmacokinetic results showed a progressive reduction in any
increase in the maximum blood concentrations (Cmax)
levels, with evidence that the Cmax was approaching, or
had reached, a plateau.
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."
1World 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.