Achieve Life Sciences has announced the completion of a final follow-up visit for the last patient in its OCRA-3 trial investigating cytisinicline for smoking cessation and nicotine dependence. The final milestone within the Phase III trial will now allow determination of the primary endpoint – measured by continuous abstinence during the last four weeks of treatment.

According to the World Health Organisation, tobacco use is currently the leading cause of preventable death worldwide – responsible for more than eight million mortalities per year. Currently, nicotine-based treatment dominates smoking cessation markets. If approved by FDA, cytisinicline, a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor, would be the first non-nicotine smoking prescription treatment in the US in nearly 20 years.

“The trial will be determined to be successful if either or both of the cytisinicline treatment arms show a statistical benefit when compared independently to the placebo arm,” the company said.

The blinded, placebo-controlled trial operated across 20 clinical locations, with 792 subjects received 3mg cytisinicline, dosed 3 times daily for either 6 or 12 weeks, and monitored through 24 weeks post-randomisation. Topline data is expected in the second quarter of 2023.

Earlier in 2023, the company announced the last follow-up visit for the ORCA-V1 trial. The ORCA-V1 is investigating cytisinicline for cessation of nicotine e-cigarette users.

“We are pleased to have reached this final milestone in the Phase 3 ORCA-3 trial and continue to expect topline data results from this trial, as well as results from the ORCA-V1 trial of cytisinicline as a treatment for e-cigarette cessation, to be reported in the second quarter of this year,” commented John Bencich, CEO of Achieve.

The company, headquartered in Washington, US, announced total net loss of $42.4m in 2022.