Designed to Assess the Efficacy and Safety of 3 mg Cytisinicline Three Times Daily Dosing Compared to Placebo

Phase 3 ORCA-2 Trial to Enroll 750 Smokers Across 15 Clinical Trial Sites in the United States

SEATTLE, Wash and VANCOUVER, British Columbia, October 7, 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, today announced initiation of the Phase 3 ORCA-2 clinical trial. ORCA-2 will evaluate the efficacy and safety of 3 mg cytisinicline dosed 3 times daily compared to placebo in 750 adult smokers at 15 clinical sites in the United States.

“We are very excited to be participating in this important trial that will hopefully lead to a widely available new treatment option for smokers in the U.S. and around the globe,” commented Nancy Rigotti, MD, Massachusetts General Hospital, Professor of Medicine at Harvard Medical School, and Primary Investigator of the ORCA-2 trial. “Smoking remains the number one cause of preventable death and we clearly need new options to help people who smoke avoid the enormous toll of illness and death attributable to cigarette smoking.”

ORCA-2 participants will be randomized to one of three study arms to determine the smoking cessation efficacy and safety profile of cytisinicline administered for either 6 or 12 weeks, compared to placebo. All subjects will receive standard behavioral support and will be assigned to one of the following groups:

  • Arm A: 12 weeks of placebo
  • Arm B: 6 weeks of cytisinicline, followed by 6 weeks of placebo
  • Arm C: 12 weeks of cytisinicline

The primary outcome measure of success in the ORCA-2 trial is biochemically verified continuous abstinence during the last four weeks of treatment in the 6 and 12-week cytisinicline treatment arms compared to placebo.  Each treatment arm will be compared independently to the placebo arm, and the trial will be determined to be successful if either or both of the cytisinicline treatment arms show a statistical benefit compared to placebo. Secondary outcome measures will be conducted to assess