Rapid Progress on Advancing Clinical Program with Commencement of Pharmacokinetic (PK) & Pharmacodynamic (PD) Cytisine Study and Completion of Enrollment in Food Effect PK Study

BOTHELL, Wash and VANCOUVER, British Columbia, Oct. 4, 2017 — Achieve Life Sciences, Inc. (NASDAQ: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisine for smoking cessation, today announced the commencement of a multi-dose study to evaluate both PK and PD characteristics of cytisine.

In preparation to initiate a pivotal Phase 3 trial in the United States, Achieve recently began enrollment in a multi-dose, PK/PD clinical study. An assessment of PK parameters and PD effects is planned to be conducted on both the 1.5mg standard and 3.0mg higher-dose of cytisine administered over the currently indicated 25-day scheduled duration of cytisine treatment. Additional data will be collected to help further inform the Phase 3 trial design. The multi-dose PK/PD study is expected to be completed by the end of the year, with data expected by the first-quarter of 2018.

Additionally, Achieve recently completed enrollment in a clinical study evaluating the effect of food on the bioavailability of 3mg cytisine. Data analysis is ongoing and results are expected to be announced by the end of the year.

“We are making rapid progress on the cytisine clinical development program which is essential in meeting our timelines for further discussions with the FDA prior to initiation of our Phase 3 trial, currently expected in mid-2018,” said Rick Stewart, Chairman and CEO of Achieve. “According to the Centers for Disease Control and Prevention, tobacco use remains the leading cause of preventable death and cigarette smoking is responsible for more than 480,000 lives lost each year in the U.S. alone. Our mission at Achieve is to bring cytisine forward as a new treatment option to help the millions of smokers who are battling nicotine and tobacco addiction.”

Cytisine is an established smoking cessation treatment that has been approved and marketed in Central and Eastern Europe for more than 15 years. It is estimated that over 20 million people have used cytisine to help combat nicotine addiction, including over 2,000 patients in investigator-conducted, Phase 3 clinical trials in Europe and New Zealand.

About Cytisine
Achieve’s focus is to address the global smoking health epidemic through the development and commercialization