Achieve Life Sciences has commenced the Phase IIb ORCA-1 trial to investigate the effectiveness of cytisinicline in comparison with placebo to help people quit smoking.
ORCA-1 is the first trial of the company’s Ongoing Research of Cytisinicline for Addiction (ORCA) programme that seeks to examine the efficacy of cytisinicline to help quit smoking and potentially other indications.
As part of the ORCA-1 trial, Achieve Life Sciences intends to analyse both the 1.5mg and 3mg doses of cytisinicline on a decreasing titration schedule over a period of 25 days, with doses administered three times a day.
The randomised, blinded trial will be carried out at eight centres across the US and is expected to include around 250 smokers.
Its primary efficacy objective is a reduction in the number of cigarettes smoked during treatment, while the secondary analyses will comprise smoking quit rates, safety, and compliance.
Achieve Life Sciences chairman and CEO Rick Stewart said: “The initiation of the ORCA-1 trial demonstrates our continued progress and commitment to expeditiously developing cytisinicline as a treatment for smoking cessation in the US.
“We intend to utilise our learnings from this trial to finalise the Phase III programme, expected to begin later next year.”
Cytisinicline is a plant-based alkaloid with a high binding similarity to the nicotinic acetylcholine receptor. It is expected to help in quiting smoking by interacting with nicotine receptors in the brain.
It is estimated that 28.6% of all cancer deaths in the US are caused by cigarette smoking.
The trial is scheduled to provide results next year.