ORCA-2 Designed to Assess the Efficacy and Safety of 3 mg Cytisinicline Three Times Daily Dosing Compared to Placebo in Adult Smokers in the United States

SEATTLE, Wash and VANCOUVER, British Columbia, June 29, 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 that the Phase 3 ORCA-2 trial of cytisinicline has reached its enrollment target of 750 adult smokers. The ORCA-2 trial sites are no longer enrolling new subjects, however those currently in screening will be allowed to participate provided they meet entry criteria.

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 and will be compared with placebo.  Subjects in the trial will be monitored through 24 weeks post randomization and will receive standard behavioral support for the duration of the trial. More than 750 participants have been randomized across the 17 clinical sites in the United States.

“There remain more than 50 million Americans addicted to some form of tobacco, including over 34 million cigarette smokers in the United States alone and complet