Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage
pharmaceutical company committed to the global development and
commercialization of cytisinicline for smoking cessation and
nicotine dependence, today announced that it has reached agreement
with the U.S. Food and Drug Administration (FDA) on the adequacy
and timing of long-term cytisinicline exposure data requirements
for a New Drug Application (NDA).
During pre-NDA discussions held in the fourth quarter of 2023,
the FDA expressed support for an NDA submission based on adequate
data to assess for efficacy from the two completed randomized and
controlled Phase 3 trials, ORCA-2 and ORCA-3. In addition, the FDA
advised that long-term exposure data to assess for safety beyond 12
weeks would be needed to adequately evaluate safety risks given
that the FDA views smoking cessation drugs as products for chronic,
repeat, or intermittent use as patients may relapse and require
subsequent courses of treatment over a lifetime.
Achieve and the FDA have reached agreement that a single,
open-label study evaluating for long-term safety exposure of
cytisinicline will be sufficient to complete the requirement and
enable an NDA submission anticipated in the first half of 2025.
Based on FDA agreement, Achieve's NDA submission will include
safety data on at least 300 subjects who have received cumulative
cytisinicline treatment for six months. Prior to potential
approval, Achieve will provide the FDA with safety data from at
least 100 subjects treated with cytisinicline for a cumulative
duration of one year.
Achieve plans to initiate the “ORCA-OL” open label exposure
trial in the second quarter of 2024, which will include
investigators and sites who have participated in the ORCA clinical
trial program (ORCA-2, ORCA-3, and ORCA-V1 studies). ORCA-OL will
recruit from the more than 1,700 subjects who have participated in
these prior trials, including more than 1,100 who have already
received cytisinicline treatment for either 6 or 12-weeks. The
required total cumulative exposure data for NDA submission and
potential final approval will combine the previous subjects’
treatment received during their respective ORCA-2, ORCA-3, or
ORCA-V1 study participation plus their exposure during the ORCA-OL
study. This allows for faster collection of cumulative long-term
exposure safety data for the NDA submission. Subjects in ORCA-OL
will receive cytisinicline treatment for up to one year and will be
monitored for safety.
“We anticipate that data from this long-term exposure study will
support the expected use of cytisinicline by patients multiple
times throughout their journey to nicotine abstinence,” commented
Cindy Jacobs, Achieve’s President & Chief Medical Officer.
“Additionally, we expect this safety data will be supportive of a
future cytisinicline label expansion for vaping cessation.”
Achieve also announced an approximately $124.2 million
financing, which includes $60 million upfront from the sale of
common stock and up to an additional $64.2 million upon the
exercise of milestone-driven warrants. The milestone-driven
warrants will expire on the earlier of (i) three and one-half years
following the date of issuance and (ii) 30 days following Achieve’s
public disclosure of the acceptance of an NDA for cytisinicline by
the FDA in a Day 74 Letter or equivalent correspondence. Achieve
has also reached non-binding agreement with Silicon Valley Bank on
an extension of the maturity date into December 2025 on its
outstanding loan.
“We are pleased to now have clarity from the FDA and we are
excited about the vote of confidence from leading life science
investors who share our enthusiasm for cytisinicline’s potential,”
said John Bencich, Achieve’s Chief Executive Officer. “As we
continue our discussions with potential commercial partners, we are
funded to conduct the ORCA-OL trial and complete the planned NDA
submission, bringing us closer to our goal of helping the millions
of people who struggle with nicotine dependence.”
Achieve expects that existing cash, cash equivalents and
restricted cash, together with the net proceeds from the financing,
will provide adequate funding through the anticipated NDA filing in
the first half of 2025. If all of the milestone-driven warrants are
exercised in full, Achieve expects to have runway into 2026 and
through potential FDA approval.
About Achieve and Cytisinicline Achieve’s focus
is to address the global smoking health and nicotine addiction
epidemic through the development and commercialization of
cytisinicline. There are an estimated 28 million adults in the
United States alone who smoke combustible cigarettes.1 Tobacco use
is currently the leading cause of preventable death that is
responsible for more than eight million deaths worldwide and nearly
half a million deaths in the United States annually.2,3 More than
87% of lung cancer deaths, 61% of all pulmonary disease deaths, and
32% of all deaths from coronary heart disease are attributable to
smoking and exposure to secondhand smoke.3
In addition, there are over 11 million adults in the United
States who use e-cigarettes, also known as vaping.3 In 2023,
approximately 2.1 million middle and high school students in the
United States reported using e-cigarettes.4 Currently, there are no
FDA-approved treatments indicated specifically as an aid to
nicotine e-cigarette cessation.
Cytisinicline is a plant-based alkaloid with a high binding
affinity to the nicotinic acetylcholine receptor. It is believed to
aid in treating nicotine addiction for smoking and e-cigarette
cessation by interacting with nicotine receptors in the brain,
reducing the severity of withdrawal symptoms, and reducing the
reward and satisfaction associated with nicotine products.
Cytisinicline is an investigational product candidate being
developed for the treatment of nicotine addiction and has not been
approved by the Food and Drug Administration for any indication in
the United States. For more information on cytisinicline and
Achieve visit www.achievelifesciences.com.
Forward Looking StatementsThis 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
timing and nature of cytisinicline clinical development and
regulatory review and approval, statements regarding the completion
of the offering, the expected net proceeds of the offering, the
intended use of the proceeds of the offering and the expected
sufficiency of such proceeds to fund the development of
cytisinicline through potential FDA approval, data results and
commercialization activities, the potential market size for
cytisinicline, the potential benefits, efficacy, safety and
tolerability of cytisinicline, the ability to discover and develop
new uses for cytisinicline, including but not limited to as an
e-cigarette cessation product, and the development and
effectiveness of new treatments. 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; risks related
to the impact on our business of macroeconomic conditions,
including inflation, rising interest rates, instability in the
global banking sector, and public health crises, such as the
COVID-19 pandemic 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.
Investor Relations ContactNicole
Jonesachv@cg.capital (404) 736-3838Media
ContactGlenn SilverGlenn.Silver@Finnpartners.com(646)
871-8485
References1Cornelius ME, Loretan CG, Jamal A,
et al. Tobacco Product Use Among Adults – United States, 2021. MMWR
Morb Mortal Wkly Rep 2023;72:475–483.2World Health Organization.
WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World
Health Organization, 2017.3U.S. Department of Health and Human
Services. The Health Consequences of Smoking – 50 Years of
Progress. A Report of the Surgeon General, 2014.4Birdsey J,
Cornelius M, Jamal A, et al. Tobacco Product Use Among U.S. Middle
and High School Students — National Youth Tobacco Survey, 2023.
MMWR Morb Mortal Wkly Rep 2023;72:1173–1182.
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