Achieve Life Sciences, Inc. (Nasdaq: ACHV) has announced the completion of enrollment in its Phase 3 ORCA-OL clinical trial and provided a corporate update on its cytisinicline development program. The company remains focused on advancing cytisinicline for the treatment of nicotine dependence, addressing the urgent need for effective smoking and vaping cessation solutions.
ORCA-OL Trial Enrollment Completed
The ORCA-OL clinical trial, designed to evaluate the long-term safety of a 3 mg cytisinicline regimen for smoking and vaping cessation, has completed enrollment with 479 participants across 29 U.S. sites. This trial is a key requirement for Achieve’s planned NDA submission in the second quarter of 2025. The trial enrolled rapidly, in just over four months, and the Data Safety Monitoring Committee completed its initial review, concluding that there are no safety concerns and the study may proceed as planned.
FDA Breakthrough Therapy Designation
In July, the FDA granted Breakthrough Therapy designation for cytisinicline for nicotine e-cigarette, or vaping, cessation. This designation is intended to expedite the development and review of treatments for serious conditions, demonstrating promising clinical evidence of significant improvement over current therapies.
Leadership and Launch Preparedness
Recent leadership appointments, including Richard Stewart as CEO and Thomas King as Executive Chairman, underscore Achieve’s commitment to strategic growth. The commercial launch readiness team will be led by Chief Commercial Officer, Jaime Xinos, with Dr. Mark Rubinstein as the new Head of Medical Affairs.
Financial Update
As of September 30, 2024, Achieve Life Sciences reported cash, cash equivalents, restricted cash, and short-term investments totaling $42.9 million. Total operating expenses for the three and nine months ended September 30, 2024, were $12.5 million and $26.9 million, respectively. The total net loss for the three and nine months ended September 30, 2024, was $12.5 million and $27.5 million, respectively. As of November 7, 2024, Achieve had 34,389,946 shares outstanding.
Cytisinicline: Addressing Nicotine Addiction
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.
