Achieve Life Sciences Completes ORCA-OL Enrollment & First Safety Data Review

SEATTLE and VANCOUVER, British Columbia, Oct. 10, 2024 - Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company focused on developing and commercializing cytisinicline for nicotine dependence treatment, has provided an update on the ORCA-OL clinical trial. This trial evaluates the long-term exposure of the novel 3 mg cytisinicline dosing regimen in individuals who smoke or vape nicotine.

The enrollment for the ORCA-OL trial has been successfully completed, with 479 participants recruited from 29 clinical trial sites across the United States. The participants and clinical sites had previously been involved in Achieve's ORCA program, which aims to research cytisinicline for smoking and e-cigarette cessation. This prior involvement is believed to have contributed to the rapid enrollment of the current trial, which concluded in just over four months. Achieve is confident that the number of participants enrolled will provide the necessary safety data required by the U.S. Food and Drug Administration (FDA).

Additionally, the first review by the Data Safety Monitoring Committee (DSMC) for the ORCA-OL trial has been completed. The DSMC reported no safety concerns, indicating that the overall safety profile of the study is excellent and that the trial can continue as planned without any modifications.

Cindy Jacobs, PhD, MD, President and Chief Medical Officer of Achieve, expressed confidence in the trial's progress, highlighting the urgent need for a new smoking cessation treatment. Jacobs stated that completing this milestone brings the company closer to filing the cytisinicline New Drug Application (NDA) in the first half of 2025. Jacobs also thanked the DSMC members for their diligent oversight in monitoring the long-term use of cytisinicline.

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

To date, Achieve has successfully completed two Phase 3 clinical trials involving over 1,600 subjects who smoke combustible cigarettes and one Phase 2 clinical trial for adults who vape nicotine e-cigarettes and wish to quit. In July 2024, the FDA granted Breakthrough Therapy Designation to cytisinicline for treating e-cigarette dependence. Achieve plans to meet with the FDA soon to finalize further evaluation plans for the vaping cessation indication.

Achieve Life Sciences is focused on addressing the global health crisis of smoking and nicotine addiction through the development and commercialization of cytisinicline. In the United States alone, there are approximately 29 million adults who smoke combustible cigarettes. Tobacco use is the leading cause of preventable death, responsible for over eight million deaths worldwide, including nearly half a million annually in the U.S.

Moreover, over 11 million adults in the U.S. use e-cigarettes, also known as vaping. In 2024, around 1.6 million middle and high school students in the U.S. reported using e-cigarettes. Currently, no FDA-approved treatments specifically aid nicotine e-cigarette cessation.

Cytisinicline, a plant-based alkaloid, has a high binding affinity to the nicotinic acetylcholine receptor. It is believed to help treat nicotine addiction for both smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing nicotine cravings and decreasing the reward associated with nicotine use. Cytisinicline remains an investigational product candidate and has not yet received FDA approval for any indication in the United States.