SEATTLE, Wash. and VANCOUVER, British Columbia, March 12, 2020 – 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, announced that additional analyses from the ORCA-1 Phase 2b trial will be presented today, Thursday, March 12th, at the SRNT Annual Meeting in New Orleans.

Previously reported data from the ORCA-1 trial of 254 smokers demonstrated significant quit rates in all cytisinicline-treated subjects compared to placebo, particularly in the 3.0 mg cytisinicline-treated three times daily (TID) arm. Smokers who received 3.0 mg cytisinicline dosed TID over 25 days demonstrated a 54% abstinence rate at week 4 compared to 16% for placebo (p < 0.0001). A 4-week continuous abstinence rate, weeks 5 through 8, of 30% for cytisinicline was also observed compared to 8% for placebo (p= 0.005).

New analyses from the ORCA-1 trial indicate that the cytisinicline benefit, abstinence and reduction in number of cigarettes smoked, was consistently observed across all demographics, smoking history, and clinical trial locations. Additionally, clinical benefit was observed with cytisinicline regardless of prior smoking cessation treatments utilized, including Chantix® (varenicline), Zyban® (bupropion), or Nicotine Replacement Therapy (NRT). Smokers in the ORCA-1 trial had an average smoking history of 32.1 years, smoked 18 cigarettes per day, and had 4.5 previous quit attempts, indicating a highly nicotine-addicted population.

New analyses also demonstrate cytisinicline biochemical efficacy via measurement of serum cotinine as well as the previously reported carbon monoxide (CO) efficacy