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.
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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.
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By GlobalData“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.
