Achieve Life Sciences announces results from ORCA-1 trial of cytisinicline
Achieve Life Sciences 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, or TID, for Phase 3 development. The primary endpoint was the reduction in daily smoking, a self-reported measure. 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 Company expects to conduct further analyses of the ORCA-1 trial and submit data for presentation at a future medical meeting. Additionally, Achieve plans to discuss the trial's outcome with the FDA and finalize Phase 3 protocol details in the second-half of 2019.