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Achieve Announces Completion of Target Enrollment of 750 Subjects in Phase 3 ORCA-2 Smoking Cessation Trial of Cytisinicline
ORCA-2 Designed to Assess the Efficacy and Safety of 3 mg Cytisinicline Three Times Daily Dosing Compared to Placebo in Adult Smokers in the United
About this update from Achieve Life Sciences, Inc.
[{"type":"text","content":"ORCA-2 Designed to Assess the Efficacy and Safety of 3 mg Cytisinicline Three Times Daily Dosing Compared to Placebo in Adult Smokers in the United StatesSEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / June 29, 2021 / 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 Phase 3 ORCA-2 trial of cytisinicline has reached its enrollment target of 750 adult smokers. The ORCA-2 trial sites are no longer enrolling new subjects, however those currently in screening will be allowed to participate provided they meet entry criteria.The ORCA-2 trial is 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 and will be compared with placebo. Subjects in the trial will be monitored through 24 weeks post randomization and will receive standard behavioral support for the duration of the trial. More than 750 participants have been randomized across the 17 clinical sites in the United States.\"There remain more than 50 million Americans addicted to some form of tobacco, including over 34 million cigarette smokers in the United States alone and completion of ORCA-2 enrollment is a critical milestone in advancing cytisinicline, a potential new treatment that could make a major impact on the global public health smoking epidemic,\" stated John Bencich, Chief Executive Officer of Achieve. \"We extend our gratitude to the participants in the ORCA-2 trial and wish them much success in their quitting journey, as well as to our clinical trial sites for all of their hard work.\"Topline ORCA-2 data results are expected to be reported within the first half of 2022. The primary outcome measure of success in the ORCA-2 trial is biochemically verified continuous abstinence during the last four weeks of treatment in either the 6 or 12-week cytisinicline treatment arms as compared with placebo. Each treatment arm will be compared independently to the placebo arm, and the trial will be declared successful if either or both cytisinicline treatment arms show a statistical benefit as compared with placebo. Secondary outcome measures include continued abstinence rates to 6 months after study r...