Achieve Life Sciences, Inc. announced that target enrollment of 750 subjects has been reached in the Phase 3 ORCA-3 trial. Similar to the previously reported ORCA-2 trial, ORCA-3 is evaluating the smoking cessation efficacy, safety, and tolerability of 3 mg cytisinicline dosed three times daily (TID) for either 6 or 12 weeks compared with placebo. ORCA-3 participants will be monitored through 24 weeks post randomization and will receive standard behavioral support for the duration of the trial.

More than 750 adult smokers have been randomized across 20 clinical trial locations in the United States. Trial sites are no longer enrolling new subjects, but those currently in screening will be allowed to participate provided they meet entry criteria. Topline results are expected to be reported in the first half of 2023.

In April 2022, Achieve announced positive, statistically significant results in its Phase 3 ORCA-2 clinical trial of cytisinicline in 810 adult smokers across 17 clinical trial locations in the United States. ORCA-2 evaluated the efficacy and safety of 3 mg of cytisinicline dosed three times daily for either 6 or 12 weeks compared to placebo in adult smokers. Both the primary and secondary endpoints demonstrated increased quit rates, showing 6-8 times increased odds of smoking abstinence when compared to placebo.

Cytisinicline was well tolerated with single-digit rates of adverse events observed and no treatment-related serious adverse events reported. If approved by the U.S Food and Drug Administration, or FDA, cytisinicline would be the first, non-nicotine smoking cessation prescription treatment made available to American smokers in nearly two decades.