Achieve Life Sciences Announces Results from Evaluation of Cytisinicline (cytisine) versus Chantix® (varenicline) in 5-HT3 Receptor Binding Assay Study

Rhea-AI Summary

Achieve Life Sciences (NASDAQ: ACHV) presented findings at the SRNT-E Annual Meeting on cytisinicline, a smoking cessation treatment. Research shows that cytisinicline has a significantly lower binding affinity at the 5-HT₃ receptor compared to varenicline, which may explain its reduced incidence of nausea and vomiting. Conducted by researchers at the University of Cambridge, the study underscores the importance of side effects on treatment compliance, potentially impacting smoking cessation success. Achieve continues to develop cytisinicline as an effective alternative for nicotine addiction.

Positive

• Cytisinicline has significantly lower receptor binding affinity compared to varenicline, which may lead to fewer side effects.
• The study reinforces cytisinicline's potential effectiveness for smoking cessation, enhancing its market prospects.

Negative

• The ongoing development of cytisinicline faces risks, including regulatory approval challenges and potential market competition.

SEATTLE, and VANCOUVER, British Columbia, Sept. 18, 2020 /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 data presented at the Society for Research on Nicotine and Tobacco European (SRNT-E) Annual Meeting.

The presentation, "Cytisine's Lower Potency at 5-HT₃ Receptors May Explain its Lower Incidence of Nausea and Vomiting than Varenicline", provides a rationale based on detailed receptor pharmacology to explain why the incidence of nausea and vomiting associated with cytisinicline appears to be consistently lower than that seen with varenicline.

The study, conducted at the University of Cambridge Department of Biochemistry by Professor Sarah Lummis and Dr. Kerry Price, was designed to examine the in vitro binding characteristics of cytisinicline compared to varenicline at the human 5-HT₃ receptor. Using a radioligand antagonist displacement design, the study reported an IC₅₀ of 0.50 mM for cytisinicline and 0.25 µM for varenicline, representing a 2000-greater fold agonist binding affinity to the 5-HT₃ receptor for varenicline compared to cytisinicline.

"It is well-established that agonist activation of 5-HT₃ receptors in the brain stem directly leads to nausea and vomiting. These data provide further rationale to explain what has been consistently observed in clinical studies reporting the adverse event profiles of cytisinicline and varenicline," commented Achieve's Chief Scientific Officer, Dr. Anthony Clarke. "Nausea and vomiting can greatly impact smoker's compliance with medication, their willingness to complete the course of treatment, and ultimately, their ability to successfully quit smoking."

Additional safety and efficacy data from the RAUORA head-to-head non-inferiority trial of cytisinicline vs. varenicline will be presented later today by Dr. Natalie Walker at 4:15PM CET. For additional information please visit http://ir.achievelifesciences.com/events-and-webcasts.

About Achieve and Cytisinicline
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 and nicotine addiction 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, the timing and nature of cytisinicline clinical development activities, the potential market size for cytisinicline and the effectiveness and potential uses and 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 cytisinicline may not be effective in treating a larger breadth of diseases and addictions; 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; impacts from 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.

Media Contact  
Glenn Silver
Glenn.Silver@Finnpartners.com 
(646) 871-8485

Investor Relations Contact
Jason Wong
jwong@bplifescience.com 
(415) 375-3340 ext. 4

Chantix® is a registered trademark of Pfizer 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 - 182.e1

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SOURCE Achieve Life Sciences, Inc.

FAQ

What were the findings presented by Achieve Life Sciences at the SRNT-E Annual Meeting regarding ACHV?

Achieve Life Sciences presented that cytisinicline has a significantly lower incidence of nausea and vomiting compared to varenicline, attributed to its lower binding affinity at the 5-HT3 receptor.

What is the significance of the receptor binding study for cytisinicline and varenicline?

The study indicates that the lower receptor binding affinity of cytisinicline may lead to better treatment compliance and success in smoking cessation efforts.

When and where was the Achieve Life Sciences data presented?

The data was presented on September 18, 2020, at the Society for Research on Nicotine and Tobacco European Annual Meeting.

What is the current status of cytisinicline's development and commercialization?

Cytisinicline is in clinical development and has been used in Central and Eastern Europe for over two decades, but faces risks related to regulatory approval and competition.

How does cytisinicline compare to varenicline in terms of side effects?

Cytisinicline appears to have a lower incidence of nausea and vomiting compared to varenicline, making it potentially more tolerable for smokers.