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Achieve Life Sciences Announces Positive Phase 2 ORCA-V1 Trial Results Showing Statistically Significant Vaping Cessation Benefit for Participants Treated with Cytisinicline
First Randomized, Placebo-Controlled Clinical Study to Report Successful E-Cigarette Cessation Benefit with Pharmacological Treatment Study Supports Potential
About this update from Achieve Life Sciences, Inc.
[{"type":"text","content":"First Randomized, Placebo-Controlled Clinical Study to Report Successful E-Cigarette Cessation Benefit with Pharmacological Treatment Study Supports Potential Broad Utilization of Cytisinicline for Treatment of Nicotine Dependence Management to Host Conference Call Today, April 20, 2023, at 8:30 AM EDT SEATTLE and VANCOUVER, British Columbia, April 20, 2023 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today reported positive topline results from its Phase 2 ORCA-V1 trial. ORCA-V1 evaluated the efficacy and safety of 3mg cytisinicline dosed three times daily for 12 weeks compared to placebo in 160 adults who use e-cigarettes or nicotine vapes and who do not currently smoke cigarettes. All participants received behavioral support for nicotine cessation. The primary endpoint for ORCA-V1 was biochemically verified continuous abstinence from nicotine e-cigarette use, measured during the last 4 weeks of treatment. Subjects who received 12 weeks of cytisinicline treatment had 2.6 times higher odds, or likelihood, to have quit vaping during the last 4 weeks of treatment compared to subjects who received placebo (p=0.035). The vaping cessation rate during weeks 9-12 was 31.8% for cytisinicline compared to 15.1% for placebo. A benefit in favor of cytisinicline was consistently observed across the secondary endpoints. Additionally, a cessation benefit was observed for cytisinicline across clinical trial sites and participant demographics such as age, gender, race, or whether they had smoked cigarettes in the past. “These groundbreaking results from ORCA-V1 reaffirm our confidence that cytisinicline could be a safe and effective option to treat nicotine dependence,” said Dr. Cindy Jacobs, Chief Medical Officer and President at Achieve Life Sciences. “We believe that cytisinicline has the potential to become the first treatment for nicotine vaping cessation, offering new hope to those who want to quit e-cigarettes.” Cytisinicline was well tolerated and no serious adverse events were reported. Similar rates of adverse events (AE’s) were observed between treatment arms (54.7% in the placebo arm vs. 50.9% in the cytisinicline arm). The most commonly reported (>5%) AEs in...