Benzinga | Jan 4, 2022 08:33AM EST

Achieve Life Sciences Announces Completion Of Last Subject, Last Follow-Up Visit In Phase 3 ORCA-2 Trial Of Cytisinicline For Smoking Cessation

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 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.

"Completion of the follow-up phase in the ORCA-2 trial represents another significant milestone in our cytisinicline development pipeline," commented Dr. Cindy Jacobs, President and Chief Medical Officer of Achieve. "We look forward to sharing topline data from the study in the coming months and continuing to move our pipeline forward through initiation of enrollment in the ORCA-3 and ORCA-V1 trials in 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.