Topline data from ORCA-1 trial expected in mid-2019

SEATTLE, Wash. and VANCOUVER, British Columbia, Feb. 20, 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 the completion of full enrollment in the ORCA-1 trial of cytisinicline. ORCA-1 is the first in Achieve’s ORCA (Ongoing Research of Cytisinicline for Addiction) Program, which aims to evaluate the effectiveness of cytisinicline for smoking cessation and potentially other addiction indications.

The Phase 2b trial is evaluating a 25-day treatment course of 1.5 mg or 3.0 mg doses of cytisinicline using either a declining titration schedule or three times daily dosing. The trial is randomized and blinded to compare the effectiveness of the cytisinicline doses and schedules to respective placebo groups. The primary efficacy endpoint is the overall reduction in the number of cigarettes smoked during the treatment period, with secondary analyses being conducted on smoking cessation rates, safety, and compliance. Smokers who are participating in the trial receive standardized behavioral support.

ORCA-1 was initiated in October 2018 and enrolled 254 smokers at eight centers across the United States. The trial’s Data Safety Monitoring Committee met recently and concluded there are no safety concerns for subjects a