Achieve declares preliminary data from Phase I/II PK/PD study of cytisine
Achieve Life Sciences which is a clinical-stage pharmaceutical company devoted to the global development and commercialization of cytisine ensuring routing smoking or terminating smoking declared Phase I/II multi-dose, pharmacokinetic and pharmacodynamics (PK/PD) clinical study of cytisine.
Cytisine is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is an established smoking cessation treatment that has been available in Central and Eastern Europe for more than 20 years. Achieve is collaborating with leading opinion leaders and researchers to facilitate cytisine availability globally as well as in the United States.
The study evaluated the repeat-dose of PK and PD effects of 1.5mg and 3mg cytisine in 24 healthy volunteer smokers aged 18-65 years when administered over the standard 25-day course of treatment. The PK results suggested anticipated increases in plasma concentration between standard and higher doses of cytisine. Smokers in the study were not entailed to possess a designated or predetermined quit date.
Results proved 58% of the subjects overall in the trial achieved biochemically verified smoking abstinence at day 26. Half (6/12) of the subjects on the 1.5mg arm and 67% (8/12) of the subjects on the 3.0mg arm achieved abstinence on day 26. Even if complete routing was not attained, significant reduction in the number of daily cigarettes smoked were certainly attained.
Side-effects were mostly well-tolerated and mild. Transient headache was the most commonly reported event, but was not treatment-limiting. No adverse events were severe, serious, or led to withdrawal from the study.
Dr. Cindy Jacobs, Executive Vice President and Chief Medical Officer at Achieve said “he abstinence rates observed with cytisine are particularly impressive given the short 25-day treatment period. In addition, subjects did not commit to quitting and received only minimal behavioral support. Setting an actual quit date and receiving enhanced behavioral support are key factors to improve smoking cessation outcomes.”