Achieve Life Sciences Announces Publication of Cytisinicline Phase 3 ORCA-2 Smoking Cessation Trial in Journal of the American Medical Association (JAMA)

Cytisinicline 6- and 12-week dosing schedules, with behavioral support, demonstrated “smoking cessation efficacy and excellent tolerability”

Supports potential for cytisinicline to be the first pharmacotherapy approved for smoking cessation in nearly two decades

SEATTLE and VANCOUVER, British Columbia, July 11, 2023 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), today announced the publication in JAMA of the results from the Phase 3 ORCA-2 randomized placebo-controlled clinical trial of cytisinicline as a treatment for smoking cessation, the first large trial of this medication conducted in the United States. The study authors concluded that cytisinicline demonstrated “smoking cessation efficacy and excellent tolerability” in adult smokers. ORCA-2 was the first of two Phase 3 clinical trials to report positive outcomes for cytisinicline in smoking cessation.

As reported today, the ORCA-2 trial demonstrated that biochemically confirmed continuous smoking abstinence during the last 4 weeks of treatment, the primary outcome measure, was significantly higher for cytisinicline compared with placebo for both the 6- and 12-week treatment durations. For 6-week cytisinicline treatment vs placebo, 25.3% vs 4.4% of participants were abstinent during weeks 3 to 6, and participants receiving cytisinicline treatment had 8 times higher odds, or likelihood, to have quit smoking (odds ratio (OR) 8.0 [95% CI, 3.9-16.3]; P<.001). For 12-week cytisinicline treatment vs placebo, 32.6% vs 7.0% of participants were abstinent during weeks 9 to 12, and participants receiving cytisinicline treatment had 6 times higher odds, or likelihood, to have quit smoking (OR 6.3 [95% CI, 3.7-11.6]; P<.001). Participants taking cytisinicline also had a rapid and sustained decline in cravings and smoking urges compared with placebo during the first 6 weeks of treatment.

Continuous abstinence rates were also statistically significant through 6 months, the secondary outcome measure, for both treatment durations. For 6-week cytisinicline treatment vs placebo, 8.9% vs 2.6% of participants were abstinent during weeks 3 to 24, and participants had 4 times higher odds, or likelihood to have quit smoking (OR 3.7 [95% CI, 1.5-10.2]; P=.002). For 12-week cytisinicline treatment vs placebo, 21.1% vs 4.8% of participants were abstinent during weeks 9 to 24, and participants had 5 times higher odds, or likelihood to have quit smoking (OR 5.3 [95% CI, 2.8-11.1]; P<.001).