Subjects treated with cytisinicline were 55% more likely to quit smoking at 6 months and experienced significantly fewer side effects compared to those who received varenicline

SEATTLE, Wash and VANCOUVER, British Columbia, March 25, 2021 — 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 online publication of the results from the Phase 3 RAUORA trial in the scientific journal Addiction. The RAUORA study was led by Dr. Natalie Walker, Associate Professor at the University of Auckland, and evaluated the effectiveness and safety of cytisinicline compared to varenicline (Chantix®) as a smoking cessation aid in 679 indigenous New Zealanders (Māori) or their extended family.

The published results indicate that cytisinicline met the pre-specified non-inferiority endpoint, and was trending towards superiority with an Absolute Risk Difference of +4.29 in favor of cytisinicline (95% CI -0.22 to 8.79), and a 55% improvement in quit rates at six months in favor of cytisinicline when compared to varenicline. A Bayesian analysis of the primary efficacy outcome is ongoing.

Additionally, statistically significant fewer overall adverse events (AEs) were reported in cytisinicline-treated subjects (Relative Risk 0.56, 95% CI 0.49 to 0.65, p<0.001) including a significantly lower rate of nausea when compared to subjects on varenicline. Notably, as participants were not blinded to study drug, more subjects refused to participate and withdrew consent when randomized to varenicline compared to subjects who were randomized to cytisinicline.

“These data add to the growing body of evidence in support of cytisinicline as a much-needed, potential new treatment alternative to existing smoking cessation therapies,” said John Bencich, Chief Executive Officer of Achieve Life Sciences. “Many smokers refuse to take current medications or stop treatment when they experience side effects which impedes their ability to quit successfully. We believe the tolerability profile of cytisinicline, as shown in trials such as RAUORA, may help smokers remain on treatment and lead to better outcomes for those battling nicotine addiction.”

To access the RAUORA publication, visit https://onlinelibrary.wiley.com/doi/10.1111/add.15489.

Achieve is currently enrolling smokers in the 750-subject, Phase 3 ORCA-2 study of cytisinicline at 15 sites in the U.S. For more information on cytisinicline and the ORCA-2 study, visit www.achievelifesciences.com or www.orca-2.com.

About the RAUORA Study
The RAUORA study was conducted by the researchers at the University of Auckland, in conjunction with the Health Economics Research Group (HERG) at Brunel University London, and Lakes District Health Board. Currently, 3 in 10 Māori smoke, three times more than non-Māori, and supporting this population to quit smoking is a priority of the New Zealand government. The study compared cytisinicline administered on a schedule of 25 days of downward dosing titration followed by twice-daily dosing for a total of 12 weeks with varenicline administered on a schedule of 7 days of upward titration followed by twice-daily dosing for a total of 12