Achieve Life Sciences, Inc. announced that the last study follow-up visit for the last subject enrolled in the ORCA-2 Phase 3 trial occurred in late December 2021. The ORCA-2 trial is the first Phase 3 trial in Achieve's ORCA (Ongoing Research of Cytisinicline for Addiction) Program, 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 received standard behavioral support during treatment and while completing follow-up assessments through 24 weeks post randomization.

ORCA-2 randomized 810 subjects across 17 clinical trial sites in the United States. Topline data regarding the primary results are expected in the second quarter of 2022. Achieve's second cytisinicline Phase 3 registrational clinical trial, ORCA-3, is expected to initiate enrollment of approximately 750 adult cigarette smokers in the first quarter of 2022.

The grant-funded Phase 2 ORCA-V1 study, investigating the efficacy of cytisinicline in approximately 150 adult nicotine e-cigarette users, is expected to initiate by the end of the second quarter of 2022, dependent on grant funding timelines.