US-based pharmaceutical firm Achieve Life Sciences has signed a clinical trial supply and cooperation agreement with the University of Auckland in New Zealand to assess cytisine for smoking cessation.
Cytisine is a plant-based alkaloid with a high affinity for binding to the nicotinic acetylcholine receptor.
Under the terms of the agreement, the university’s commercial arm Auckland UniServices will provide the investigational candidate for use in Achieve’s Phase III RAUORA clinical trial.
The investigator-sponsored and led, single-blind, randomised, non-inferiority trial will assess the safety, efficacy and cost-effectiveness of cytisine in 2,140 Māori (indigenous New Zealanders) and whānau (family) of Māori subjects when compared to varenicline.
RAUORA is being conducted by the university in collaboration with the Lakes District Health Board and Brunel University London, with funding from the Health Research Council of New Zealand.
Achieve Life Sciences chairman and CEO Rick Stewart said: “We are pleased to contribute cytisine to this important initiative to help improve the health and well-being of Māori and their whānau.
“This trial is well-aligned with our mission at Achieve, which is to bring cytisine forward as a new treatment option around the globe to help the millions of smokers who are battling nicotine and tobacco addiction.”
The Phase III trial will compare quit rates at six months and expects that cytisine treatment in combination with behavioural support for 12 weeks will be similar to the effectiveness of 12 weeks of varenicline and behavioural support.
Achieve previously evaluated cytisine in two large-scale Phase III trials with a total of 2,000 patients and plans to initiate another Phase III trial mid-next year in the US.