BOTHELL, Wash and VANCOUVER, British Columbia, March 1, 2018 — Achieve Life Sciences, Inc. (NASDAQ: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisine for smoking cessation, today highlighted recent accomplishments and announced fourth quarter and year-end 2017 financial results.
- Announced preliminary results from clinical study evaluating pharmacokinetic (PK) and pharmacodynamics (PD) effects of 1.5mg and 3mg cytisine demonstrating an overall 58% abstinence rate in healthy volunteer smokers
- Expanded partnership with the University of Bristol for next generation cytisine-based therapies across multiple therapeutic categories
- Announced final results of clinical study demonstrating similar bioavailability of cytisine in fed and fasted subjects
- Entered into an exclusive long-term supply agreement with Sopharma AD for clinical and commercial supply of cytisine
“Significant advances in the cytisine development program have been achieved in the short time since the completion of our merger,” commented Rick Stewart, Chairman and Chief Executive Officer of Achieve Life Sciences. “Clinical progress with cytisine continues to provide evidence supporting the outcome of two, previously conducted Phase 3 trials and the in-market cytisine experience over the last 20 years in Eastern Europe. We look forward to continued collaboration with the smoking cessation community, regulators, and researchers, as we move towards our expected Phase 3 trial initiation later this year.”
PK/PD Study Results
In February, Achieve announced preliminary results from a study evaluating repeat-dose PK and PD effects of 1.5mg and 3mg cytisine when administered over the standard 25-day course of treatment in 24 healthy volunteer smokers, aged 18-65 years. The PK results indicated expected increases in plasma concentration with higher doses of cytisine. Smokers in the study were not required to have a designated or predetermined quit date, however, 58% of the subjects in the trial achieved biochemically verified smoking abstinence by day 26. Subjects who did not achieve abstinence had a significant reduction in the number of daily cigarettes smoked by the end of treatment. Cytisine was well-tolerated with no serious adverse events reported. The adverse events observed were mostly mild with transient headaches as the most commonly reported event with a slight increase in transient headaches in the 3 mg versus 1.5 mg cytisine dose level. The study is continuing enrollment for subjects aged >65 years.
University of Bristol Expanded Partnership
In January, Achieve announced an amendment to their Technology License Agreement with the University of Bristol. Achieve has been granted exclusive rights for all human medicinal uses of cytisine derivatives created under the License Agreement across all therapeutic categories. Under the amended collaboration agreement, studies will be conducted to generate and evaluate semi-synthetic cytisine derivatives for potential use in multiple indications across addiction and neurological disorders.
Fed/Fasted Study Results
In November, 2017, the Company announced final results of a study on the effect of food on the bioavailability of cytisine. The study evaluated the bioavailability of a single 3 mg cytisine dose under fed and fasted conditions in 24 healthy volunteer subjects. Study results demonstrated overall bioequivalence when cytisine was administered with or without food. Total excretion levels of cytisine also remained equivalent in both the fed and fasted states.
In October 2017, Achieve entered into an exclusive supply agreement with Bulgarian-based Sopharma AD for the manufacture of cytisine’s active pharmaceutical ingredient (API) and finished tablets. Achieve will have full access to the cytisine supply chain and Sopharma will manufacture sufficient cytisine to meet specified forecasted demand of cytisine in the Achieve territories. The exclusive license agreement provides supply of cytisine to Achieve for up to 20 years. Sopharma has over 20 years of experience producing cytisine through its commercialization efforts in Central and Eastern Europe. It is estimated that over 20 million people have used cytisine to treat nicotine addiction.
As of December 31, 2017, the company’s cash, cash equivalents, short-term investments and restricted cas