SEATTLE, Wash. and VANCOUVER, British Columbia, September 13, 2019 — Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today announced that two presentations featuring final data from the Phase 2b ORCA-1 trial will be conducted at the SRNT-E Annual Conference on Friday, September 13th in Oslo.
ORCA-1 was designed to evaluate cytisinicline efficacy and safety across various dosing and administration schedules in 254 smokers in the United States. Topline results, reported in June of 2019, have led to the selection of 3.0 mg, three times daily (TID) dosing for future Phase 3 development.
The 3.0 mg TID treatment arm demonstrated a 54% abstinence rate at week 4, compared to 16% for placebo (p < 0.0001) and a 4-week continuous abstinence rate, weeks 5 through 8, of 30% for cytisinicline compared to 8% for placebo (p= 0.005). Continuous abstinence for 4 weeks is the relevant endpoint for regulatory approval.
Final data included in the oral presentations at SRNT-E indicate statistically significant end-of-treatment abstinence rates of 50-54% for all cytisinicline treatment arms compared to 16% for placebo. Subjects had smoked on average for over 30 years. There were no differences observed in treatment outcomes based on subject demographics, clinical site location, number of prior smoking cessation treatments, or previous qui