Achieve Life Sciences Announces Presentation of Cytisinicline Data at the 21st Annual Society for Research on Nicotine & Tobacco (SRNT-E) Virtual Conference

Rhea-AI Summary

Achieve Life Sciences (NASDAQ: ACHV) has announced that data on cytisinicline will be presented at the Society for Research on Nicotine & Tobacco (SRNT-E) Conference from September 15-17, 2021. Key presentations include a subgroup analysis from the ORCA-1 Phase 2 study, showing a Week 4 abstinence rate of 51.3% for cytisinicline, significantly higher than the 15.8% rate for placebo (p=0.009). Another analysis highlighted a shorter time to sustained abstinence with cytisinicline, taking only 7 days compared to 18 days for placebo. Achieve's enrollment in the Phase 3 ORCA-2 trial has been completed, with results expected in early 2022.

Positive

• Cytisinicline shows a 51.3% Week 4 abstinence rate compared to 15.8% for placebo (p=0.009).
• Shorter time to sustained abstinence with cytisinicline: 7 days vs. 18 days for placebo.
• Completion of enrollment in Phase 3 ORCA-2 trial, with topline results expected in early 2022.

Negative

• Potential risks associated with the regulatory approval and commercialization of cytisinicline.
• Future market acceptance of cytisinicline remains uncertain.

SEATTLE, WA & VANCOUVER, BC / ACCESSWIRE / September 14, 2021 / Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, announced that cytisinicline data will be presented at two sessions during the upcoming Society for Research on Nicotine & Tobacco (SRNT-E) Conference to be held virtually September 15-17, 2021.

Presentation Details

• "Cytisinicline may benefit smokers who previously failed to quit smoking with varenicline: A subgroup analysis of the ORCA-1 trial"
  • A subgroup analysis from the ORCA-1 Phase 2 study of smokers who had previously failed Chantix® (varenicline) demonstrated a Week 4 abstinence rate of 51.3% upon treatment with cytisinicline using the three times daily (TID) regimen, compared with 15.8% with placebo (p= 0.009). The estimated Odds Ratios for smoking cessation through Weeks 5-8 were 1.8 for the titration and 4.3 for the TID regimen. The cytisinicline TID regimen appeared to be more effective for smokers who had previously failed to quit on varenicline than the titration regimen.
  • The data will be presented on Thursday, September 16^th, Oral Session 5:"Smoking cessation interventions in special populations".
• "Time to Sustained Abstinence with Cytisinicline in the ORCA-1 trial"
  • A new analysis of the ORCA-1 Phase 2 study determined that smokers treated in the study with cytisinicline showed an earlier onset of sustained abstinence compared with placebo. Smokers who received the cytisinicline 3 mg TID had the shortest time to sustained smoking abstinence with a median of only 7 days of treatment compared to 18 days for placebo.
  • The data will be presented on Friday, September 17^th, Poster Session 5:"Clinical".

"This additional analysis continues to reinforce our belief that the 3 mg dose of cytisinicline taken three times daily provides the greatest potential for smokers, regardless of prior treatments, to successfully quit," commented John Bencich, CEO of Achieve. "We are also pleased to have new insights on the short time to response seen with cytisinicline. We believe this early abstinence could inspire smokers to continue their treatment and stay quit."

Achieve recently announced completion of enrollment in the Phase 3 ORCA-2 clinical trial, evaluating cytisinicline as a treatment for combustible cigarette cessation. Topline results from the ORCA-2 trial are expected in the first half of 2022. For more information on Achieve Life Sciences and cytisinicline please visit www.achievelifesciences.com.

About Achieve and Cytisinicline
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 U.S. annually.^{1 2} 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.² 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.

Achieve recently announced completion of enrollment in the Phase 3 ORCA-2 clinical trial, evaluating cytisinicline as a treatment for combustible cigarette cessation. Topline results from the ORCA-2 trial are expected in the first half of 2022. For more information on Achieve Life Sciences and cytisinicline please visit www.achievelifesciences.com.

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 timing and nature of cytisinicline clinical development activities, the potential market size and market acceptance for cytisinicline, the potential benefits of cytisinicline 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; 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.

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

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

¹ World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.

² U.S. Department of Health and Human Services. The Health Consequences of Smoking - 50 Years of Progress. A Report of the Surgeon General, 2014.

Chantix^® is a registered trademark of Pfizer Inc.

SOURCE: Achieve Life Sciences, Inc.

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FAQ

What data will Achieve Life Sciences present at the SRNT-E Conference?

Achieve Life Sciences will present data showing a Week 4 abstinence rate of 51.3% for cytisinicline, significantly higher than placebo.

What were the results of the ORCA-1 trial for cytisinicline?

The ORCA-1 trial demonstrated that cytisinicline users had a Week 4 abstinence rate of 51.3%, with a median time to sustained abstinence of 7 days.

When are the results from the ORCA-2 trial expected?

Topline results from the ORCA-2 trial are expected in the first half of 2022.

What is the significance of cytisinicline in smoking cessation?

Cytisinicline aims to aid smoking cessation by interacting with nicotine receptors, potentially reducing withdrawal symptoms and cravings.

What should investors know about Achieve Life Sciences' future?

Investors should be aware of the risks related to regulatory approval and market acceptance of cytisinicline.