Achieve Life Sciences, Inc. (Nasdaq: ACHV) announced the completion of enrollment in its ORCA-OL clinical trial, designed to assess the long-term safety of a 3 mg cytisinicline dosing regimen for individuals who smoke cigarettes or vape nicotine. The trial enrolled 479 participants across 29 clinical sites in the United States.
Rapid Enrollment and Safety Profile
The ORCA-OL trial achieved rapid enrollment in just over four months, attributed to the prior involvement of clinical sites and participants in Achieve’s ORCA program for smoking and e-cigarette cessation studies. The company believes the enrollment size is sufficient to meet the safety data requirements of the U.S. Food and Drug Administration (FDA).
Furthermore, the Data Safety Monitoring Committee (DSMC) conducted its first review of the ORCA-OL trial and concluded that there were no significant safety concerns. The DSMC indicated that the overall safety profile of cytisinicline appears to be excellent, and the trial can proceed as planned without any modifications.
Management Commentary
"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," stated 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."
Trial Design and Objectives
The ORCA-OL clinical trial is specifically designed to meet the FDA requirement of providing safety data on a minimum of 300 subjects treated with cytisinicline for at least six months, as part of the anticipated New Drug Application (NDA) submission. Data on at least 100 subjects treated for a total cumulative period of one year will be provided before potential product approval.
Cytisinicline's Clinical Development
To date, Achieve has completed two Phase 3 clinical trials of cytisinicline involving over 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 to finalize plans for further evaluation of the vaping cessation indication.
About Cytisinicline
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 and has not been approved by the FDA for any indication in the United States.
Market Need
Approximately 29 million adults in the United States smoke combustible cigarettes, and over 11 million adults use e-cigarettes. Tobacco use is the leading cause of preventable death, responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually. Currently, there are no FDA-approved treatments specifically indicated for nicotine e-cigarette cessation.
