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Achieve Announces Early Completion of Target Enrollment in Cytisinicline e-Cigarette Cessation Trial
Phase 2 ORCA-V1 Data Expected in 1H2023 SEATTLE, Wash and VANCOUVER, British Columbia, Nov. 08, 2022 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq:
About this update from Achieve Life Sciences, Inc.
[{"type":"text","content":"Phase 2 ORCA-V1 Data Expected in 1H2023\nSEATTLE, Wash and VANCOUVER, British Columbia, Nov. 08, 2022 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage clinical pharmaceutical company committed to the global development and commercialization of cytisinicline for nicotine dependence, today 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 (TID), 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 (NIH) through grant funding. “The earlier-than-expected completion of enrollment in the ORCA-V1 trial further elucidates the critical need for treatment options specific for nicotine vape users who are interested in quitting,” stated John Bencich, Chief Executive Officer of Achieve. “In our previous trials, cytisinicline demonstrated a clear smoking cessation benefit compared to placebo and a very well tolerated safety profile, which we anticipate will apply to vaping cessation and treating nicotine dependence more broadly. We look forward to reporting topline results from ORCA-V1 in the first half of next year.” 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. Cytisi...