Achieve Life Science (NASDAQ:ACHV) has announced results of a clinical study evaluating the effect of food on the bioavailability of 3mg cytisine.
As quoted in the press release:
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 enrollment 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.”