Cytisinicline Up to Five Times More Likely to Result in Smoking Abstinence Compared to Placebo

Phase 3 ORCA-2 Trial Currently Enrolling at 16 sites in United States

SEATTLE, Wash and VANCOUVER, British Columbia, April 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, today announced publication of the results from the Phase 2b ORCA-1 trial in the scientific journal Nicotine and Tobacco Research.

ORCA-1 evaluated the efficacy and safety of cytisinicline across various dosing and administration schedules in 254 smokers in the United States. The published results indicate that subjects treated with cytisinicline, regardless of dose or schedule, had statistically significantly higher (p<0.001) end of treatment abstinence rates compared to those treated with placebo. Participants in the 3.0 mg cytisinicline 3 times daily (TID) arm, were 5-times more likely to quit smoking than those in the placebo arm (OR of 5.04, 95% CI: 1.42, 22.32, p<0.001).

Cytisinicline was well-tolerated with no serious or severe adverse events (AEs) reported. Overall, in subjects treated with cytisinicline, all individual AE’s reported were below a rate of 10%. In the 3.0 mg TID treatment arm versus placebo, the most common AEs were abnormal dreams, insomnia, and constipation (each 6% vs 2%), upper respiratory tract infections (6% vs 14%), and nausea (6% vs 10%). Adherence to study treatment was greater than 94% across all treatment arms and 98% in the 3.0 mg TID arm, specifically.