Achieve Life Sciences, Inc. announced that the final subject of the Company's Phase 3 ORCA-3 trial has completed treatment in the study. 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 for either 6 or 12 weeks compared with placebo. The ORCA-3 trial randomized 792 subjects in total across 20 clinical trial locations in the United States.

Participants are being monitored through 24 weeks post randomization and will receive standard behavioral support for the duration of the trial. The ORCA-3 primary endpoint is biochemically verified continuous abstinence during the last four weeks of treatment. Each treatment arm will be compared independently to the placebo arm and the trial will be determined to be successful if either or both of the cytisinicline treatment arms show a statistical benefit compared to placebo.

ORCA-3 is designed to enable U.S. Food and Drug Administration, or FDA, registration of cytisinicline, and if approved, would be the first non-nicotine smoking cessation prescription treatment made available to American smokers in nearly two decades. Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.1,2 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.

In addition, there are nearly 11 million adults in the United States who use e-cigarettes, also known as vaping. While nicotine e-cigarettes are thought to be less harmful than combustible cigarettes, they remain addictive and can deliver harmful chemicals which can cause lung injury or cardiovascular disease. In 2021, e-cigarettes were the most commonly used tobacco product reported by 1.72 million high school students.

Research shows adolescents who have used e-cigarettes are seven times more likely to become smokers one year later compared to those who have never vaped. Currently, there are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor.

It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of withdrawal symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States.