Achieve Life Sciences, Inc. announced that target enrollment has been reached in the Phase 2 ORCA-V1 clinical trial. ORCA-V1 is evaluating the efficacy and safety of cytisinicline in adult users of nicotine e-cigarettes or vapes. The study enrolled subjects who only used nicotine e-cigarettes, were not currently smoking combustible cigarettes, and who wanted to quit their vaping nicotine dependance.

The randomized, placebo-controlled trial will treat 150 subjects in a 2:1 ratio to receive either cytisinicline, dosed at 3 mg three times daily, or placebo, for a period of 12 weeks. Subjects were stratified by prior smoking history. All subjects are receiving standardized behavioral support throughout the trial.

The primary outcome will be continuous vaping abstinence during the final 4 weeks of treatment. ORCA-V1 is being supported by the National Institute on Drug Abuse (NIDA) of the National Institutes of Health through grant funding. Earlier this year Achieve announced positive, statistically significant results in its Phase 3 ORCA-2 clinical trial of cytisinicline in 810 adult smokers across 17 clinical trial locations in the United States.

ORCA-2 evaluated the efficacy and safety of 3 mg of cytisinicline dosed three times daily for either 6 or 12 weeks compared to placebo in adult smokers. Both the primary and secondary endpoints demonstrated increased quit rates, showing 6-8 times increased odds of smoking abstinence when compared to placebo. Cytisinicline was well tolerated with single-digit rates of adverse events observed and no treatment-related serious adverse events reported.

Additionally, Achieve recently announced completion of enrollment for its confirmatory Phase 3 ORCA-3 smoking cessation trial. Topline data are expected in the first half of 2023.