Achieve Life Sciences Announces Statistically Significant Improvement in Quit Rates for Simplified Cytisinicline Dosing Schedule in Phase 2B Orca-1 Dose-Selection Trial
June 11, 2019 at 07:00 am EDT
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Achieve Life Sciences, Inc. announced positive results from the ORCA-1 dose-selection trial of cytisinicline for smoking cessation. The outcome of the 254-subject, ORCA-1 trial is the selection of 3.0 mg, three times daily (TID) for Phase 3 development. The primary endpoint was the reduction in daily smoking, a self-reported measure. Three of the four cytisinicline treatment arms demonstrated a statistically significant improvement, as defined in the protocol as p < 0.05, compared to placebo. The fourth arm trended to significance (p= 0.052). Across all treatment arms, over the 25-day treatment period, subjects on cytisinicline experienced a 74-80% median reduction in the number of cigarettes smoked, compared to a 62% reduction in the placebo arms. The secondary endpoint of the trial was a 4-week continuous abstinence rate, which is the relevant endpoint for regulatory approval. Cytisinicline treatment showed significant improvements in abstinence rates compared to placebo. The most impressive results were observed in the 3 mg TID treatment arm which demonstrated a 54% abstinence rate at week 4, compared to 16% for placebo (p < 0.0001) and a continuous abstinence rate, weeks 5 through 8, of 30% for cytisinicline compared to 8% for placebo (p= 0.005).
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.