Achieve Life Sciences Announces Phase 3 ORCA-2 Trial of Cytisinicline in Smoking Cessation Clears Final Review by Data Safety Monitoring Committee
November 22, 2021 at 08:30 am EST
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Achieve Life Sciences, Inc. announced the completion of the fifth and final Data Safety Monitoring Committee (DSMC) review for its Phase 3 ORCA-2 smoking cessation trial of cytisinicline. The DSMC concluded that there are no concerns regarding the Phase 3 study conduct and the safety and adverse event profile remains favorable. Additionally, the DSMC members commented that compliance with study medication was excellent and the study has progressed well despite the challenges of the COVID-19 pandemic. 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, compared with placebo. Subjects in the trial have completed study treatment and continue to receive standard behavioral support while completing follow-up assessments through 24 weeks post randomization. Fully enrolled this July, 810 participants were randomized across the 17 clinical sites in the United States. Preliminary data is expected in the first half of 2022.
Achieve Life Sciences, Inc. is a late-stage clinical pharmaceutical company. The Company is engaged in development and commercialization of cytisinicline for smoking cessation and nicotine addiction. The Companyâs product candidate, cytisinicline, is a naturally occurring, plant-based alkaloid. Cytisinicline is structurally similar to nicotine and has a well-defined, dual-acting mechanism of action that is both agonistic and antagonistic. Cytisinicline is a partial agonist that binds with high affinity to the alpha-4 beta-2, nicotinic acetylcholine receptors in the brain. Through its dual-acting partial agonist/partial antagonist activity, cytisinicline helps reduce nicotine cravings, withdrawal symptoms and reward and satisfaction associated with smoking. It is developing cytisinicline as an aid to smoking cessation and treatment for nicotine addiction to address the limitations of both prescription drugs and of over the counter (OTC) products.