US-based specialist pharmaceutical firm Achieve Life Sciences has begun a multi-dose study to evaluate both pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of cytisine, a plant-based alkaloid with a high-binding affinity to the nicotinic acetylcholine receptor, for smoking cessation.
For more than 15 years, Cytisine, an established smoking cessation treatment, has been approved and marketed in Central and Eastern Europe.
The company recently claimed to have started patient enrolment in a multi-dose, PK / PD clinical study in preparation to begin a pivotal Phase III trial in the US.
During the PK / PD trial, an assessment of PK parameters and PD effects is planned to be conducted on both the 1.5mg standard and 3mg higher-dose of cytisine administered over the currently indicated 25-day scheduled duration of cytisine treatment.
The company noted that additional data will be collected to help further inform the Phase III trial design.
Completion of the multi-dose PK / PD study is expected to take place by the end of this year, while the results are expected by the first quarter of next year.
Achieve chairman and CEO Rick Stewart said: “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 III trial, currently expected in mid-2018.
“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 US 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.”
The company recently completed patient enrolment in a clinical trial evaluating the effect of food on the bioavailability of 3mg of cytisine. The data analysis for this is ongoing and results are expected by the end of the year.
It is reported that two prior, large-scale Phase III clinical trials of cytisine with favourable outcomes have been successfully completed in more than 2,000 patients.