Achieve Life Sciences Announces Phase 3 ORCA-2 Trial of Cytisinicline in Smoking Cessation Clears Final Review by Data Safety Monitoring Committee (DSMC)
SEATTLE, Wash and VANCOUVER, British Columbia, Nov. 22, 2021 (GLOBE NEWSWIRE) -- 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, today announced the completion of the fifth and final Data Safety Monitoring Committee (DSMC) review for its Phase 3 ORCA-2 smoking cessation trial of cytisinicline.
The DSMC concluded that there are no concerns regarding the Phase 3 study conduct and the safety and adverse event profile remains favorable. Additionally, the DSMC members commented that compliance with study medication was excellent and the study has progressed well despite the challenges of the COVID-19 pandemic.
The ORCA-2 trial is designed to evaluate the smoking cessation effectiveness, safety, and tolerability of 3 mg cytisinicline taken three times daily (TID) for either 6 or 12 weeks, compared with placebo. Subjects in the trial have completed study treatment and continue to receive standard behavioral support while completing follow-up assessments through 24 weeks post randomization. Fully enrolled this July, 810 participants were randomized across the 17 clinical sites in the United States. Preliminary data is expected in the first half of 2022.
“We are grateful to the DSMC members for their diligence and guidance during these reviews and are very pleased with the outcome,” commented Cindy Jacobs, President and Chief Medical Officer of Achieve. “The successful safety reviews during this ORCA-2 study are important for cytisinicline, as we believe the potential safety and tolerability of cytisinicline will be a key differentiator to existing treatments. We look forward to announcing ORCA-2 topline results in the first half of 2022.”
About Achieve and 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.
Cytisinicline is an investigational product candidate being developed for 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 Statements
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.
Investor Relations Contact Rich Cockrell [email protected] (404) 736-3838 Media Contact Glenn Silver [email protected] (646) 871-8485
Spectrum Wars: How do we Arm Ourselves for 6G?
Blockchain in the Enterprise: The Time is Now
Smart Buildings Beyond HVAC