Achieve Life Sciences Announces Presentation of Cytisinicline E-Cigarette Cessation (ORCA-V1) Results at Society for Research on Nicotine and Tobacco Europe (SRNT-E) Annual Meeting

SEATTLE and VANCOUVER, British Columbia, Sept. 11, 2023 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage clinical pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that Phase 2 ORCA-V1 trial results will be presented at the Society for Research on Nicotine and Tobacco Europe (SRNT-E) Annual Meeting, being held in London September 11–13, 2023.

Data from the ORCA-V1 trial, which evaluated cytisinicline as a treatment for e-cigarette cessation, will be presented today, September 11, 2023, by ORCA-V1 Principal Investigator, Dr. Nancy Rigotti, Professor of Medicine at Harvard Medical School and Director, Tobacco Research and Treatment Center, Massachusetts General Hospital.  

The positive topline results from the ORCA-V1 trial, announced earlier this year, will be presented, as well as additional findings. The primary endpoint analysis demonstrated 2.6 times higher odds, or likelihood, of vaping cessation with 3mg cytisinicline dosed three times daily for a period of 12 weeks compared to placebo in 160 adults in the U.S. who use nicotine vapes daily (p = 0.035). The study population had a mean age of 34 years, 72% had been previous smokers, and a majority vaped e-cigarettes with fruit flavoring.

Additional analyses showed that vaping abstinence with cytisinicline treatment started by the second week of treatment, with the odds of vaping cessation improving throughout the 12-week treatment period. The odds of vaping cessation for cytisinicline were 1.8 times, 2.2 times, and 2.6 times higher than placebo at Week 3-6, Week 6-9, and Week 9-12, respectively. During the Week 12-16 follow-up period, subjects treated with cytisinicline continued to demonstrate 2.0 times higher odds of vaping cessation compared to placebo.

Similar to previous trials conducted in smoking cessation, cytisinicline treatment was well tolerated with only insomnia and abnormal dreams trending higher when compared to placebo, while rates of nausea and headache were lower for the 12-week cytisinicline treatment arm than observed in the placebo arm.

“Vaping continues to be a rapidly growing public health epidemic with more than 11 million adults in the U.S. alone who have reported use of e-cigarettes,” commented John Bencich, CEO of Achieve. “The results from ORCA-V1 provide strong evidence of the potential role of cytisinicline to address nicotine dependence more broadly and, if approved by the FDA, may provide a new treatment option to the millions of people who want to quit smoking and e-cigarette use.”