EU Business News November 2017

22 EU BUSINESS NEWS / November 2017 Results of Clinical Study Achieve announces results of clinical study demonstrating similar bioavailability of cytisine in fed and fasted subjects. On the 14th November, a clinical- stage pharmaceutical company committed to the global development and commercialization of cytisine for smoking cessation, Achieve Life Sciences, Inc., announced the results of a clinical study evaluating the effect of food on the bioavailability of 3mg cytisine. The study evaluated the bioavailability of 3 mg cytisine under fed and fasted conditions in 24 healthy volunteer subjects. Study results demonstrated bioequivalence when cytisine was administered with or without food. Cytisine was extensively absorbed after oral administration with maximum cytisine concentration levels observed in the blood within less than an hour. Total excretion levels of cytisine also remained equivalent in both the fed and fasted states. Further data from this study will be submitted for presentation at an upcoming scientific congress. Additionally, in preparation to initiate a pivotal Phase 3 program in the United States, Achieve recently began enrolment in a multi-dose, pharmacokinetic and pharmacodynamics (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. The multi-dose PK/PD study is expected to have results within the first-quarter of 2018. “We are pleased with the rapid completion of this study in fed versus fasted subjects and the findings that a higher dose of 3 mg cytisine can be administered safely with or without food,” said Rick Stewart, Chairman and CEO of Achieve. “The results help to inform our future development plans, including our Phase 3 program which we expect to initiate in mid-2018.” Cytisine is an established smoking cessation treatment that has been approved and marketed in Central and Eastern Europe for more than 20 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. ,