Achieve Life Sciences has initiated the Cytisine Clinical Development Programme in the US to evaluate the product candidate as a form of treatment for smoking cessation.
Cytisine is a plant-based alkaloid that possesses a high binding affinity to the nicotinic acetylcholine receptor.
As part of the development programme, the firm is conducting a Phase III clinical trial to assess the effect of food on the bioavailability of cytosine.
Patient enrolment and dosing for this trial have commenced and data analysis is estimated to be completed in the fourth quarter of this year.
The programme also includes another Phase III trial intended to be initiated in the coming months and is designed to evaluate repeat-dose pharmacokinetic (PK) parameters and pharmacodynamics (PD).
Achieve Life Sciences chairman and CEO Rick Stewart said: “In the last month Achieve has announced the closing of our merger with OncoGenex and subsequent listing on NASDAQ, the US Food and Drug Administration (FDA) acceptance of Achieve’s cytisine investigational new drug (IND), and now the initiation of the cytisine clinical development programme.
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“We are focused on achieving our milestones with our primary goal of initiating a US pivotal Phase III trial next year.”
Cytosine is previously reported to have demonstrated an encouraging outcome in the double-blind, placebo controlled Phase III TASC trial with 740 patients, as well as in single-blind, non-inferiority Phase III CASCAID trial performed in 1,310 patients.
Cytisine has been marketed as a smoking cessation treatment in Central and Eastern Europe for more than 15 years.