Achieve Life Sciences Announces Completion of Enrollment in Clinical Trial & Successful Outcome of the First Data Safety Monitoring Committee Meeting

Achieve Life Sciences, Inc. recently announced an update on the ORCA-OL clinical trial, evaluating long-term exposure of the novel 3 mg cytisinicline treatment dosing regimen in individuals who smoke cigarettes or vape nicotine.

Enrollment for the ORCA-OL trial has been completed with an enrollment of 479 participants at 29 clinical trial sites across the United States. All clinical sites and participants were previously involved in Achieve’s ORCA “Ongoing Research of Cytisinicline for Addiction” program for smoking and e-cigarette cessation studies, which is thought to have facilitated the rapid enrollment of this trial in just over four months. Achieve believes that the 479 participants enrolled will be sufficient to meet the safety information required by U.S. Food and Drug Administration (FDA).

Additionally, Achieve announced that the first Data Safety Monitoring Committee (DSMC) review for the ORCA-OL trial has been recently conducted. The DSMC concluded that there are no safety concerns, the overall safety profile appears to be excellent, and the study may proceed as planned with no modifications.

“We believe the rapid enrollment of this trial strongly reflects the urgent medical need for a new smoking cessation treatment and we are thrilled to have completed this critical milestone, bringing us one step closer to our planned filing of the cytisinicline NDA in the first half of 2025,” said Cindy Jacobs, PhD, MD, President and Chief Medical Officer of Achieve. “We are also grateful to the DSMC members for their diligence and guidance as we continue to closely monitor the long-term use of cytisinicline with their oversight.”

The ORCA-OL clinical trial is designed to meet the FDA requirement to provide safety data on a minimum of 300 subjects treated with cytisinicline for a cumulative period of six months as part of the anticipated New Drug Application (NDA) submission. Subsequently, data on at least 100 subjects treated for a total cumulative period of one year will be provided prior to potential product approval.

To date, Achieve has successfully completed two Phase 3 clinical trials of cytisinicline in more than 1,600 subjects who smoke combustible cigarettes and one Phase 2 clinical trial for adults who vape nicotine e-cigarettes and desire to quit. In July 2024, the FDA granted Breakthrough Therapy Designation to cytisinicline for the treatment of e-cigarette dependence. The Company expects to meet with the FDA in the coming weeks to finalize plans for further evaluation of the vaping cessation indication. For more information on Achieve and cytisinicline, visit the Achieve website.

Achieve’s focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. There are approximately 29 million adults in the United States alone who smoke combustible cigarettes. 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. 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 over 11 million adults in the United States who use e-cigarettes, also known as vaping. In 2024, approximately 1.6 million middle and high school students in the US reported using e-cigarettes. 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 nicotine craving symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for the treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the US.