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 and the trial should continue as planned. ORCA-1 topline efficacy and safety data are expected to be announced in mid-2019.
“Progress on the cytisinicline development program is rapid and Achieve is grateful to the investigators and study participants for their swift enrollment and commitment to the ORCA-1 trial,” said Dr. Cindy Jacobs, Chief Medical Officer at Achieve. “We look forward to sharing the data results in the near future, which will serve to inform our Phase 3 development program.”
Additional information on cytisinicline and the ORCA program can be found at www.achievelifesciences.com and www.orcaprogram.com.
Tobacco use is currently the leading cause of preventable death and is responsible for nearly seven million deaths annually worldwide. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking. Achieve’s focus is to address the global smoking health epidemic through the development and commercialization of cytisinicline.
Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation