Achieve Life Sciences Completes Enrollment in Phase 3 ORCA-OL Trial for Cytisinicline
Key Insights
Achieve Life Sciences completed enrollment in its Phase 3 ORCA-OL trial, evaluating cytisinicline for smoking (search) and vaping (search) cessation, with 479 participants across 29 U.S. sites.
The FDA granted Breakthrough Therapy designation to cytisinicline for nicotine e-cigarette cessation, expediting its development and review.
Achieve remains on track for planned NDA submission in the second quarter of 2025, driven by the potential to address the urgent need for effective smoking (search) and vaping (search) cessation solutions.
Achieve Life Sciences has completed enrollment in the Phase 3 ORCA-OL clinical trial, marking a significant step in the development of cytisinicline for nicotine dependence (search) treatment. The trial, which includes 479 participants across 29 U.S. sites, is designed to evaluate the long-term safety of a 3 mg cytisinicline regimen for smoking (search) and vaping (search) cessation. This data is crucial for Achieve's planned New Drug Application (NDA) submission in the second quarter of 2025.
ORCA-OL Trial Details
The ORCA-OL trial rapidly enrolled participants in just over four months. The Data Safety Monitoring Committee completed its initial review and 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.
Breakthrough Therapy Designation
Cytisinicline received Breakthrough Therapy designation from the FDA in July for nicotine e-cigarette, or vaping (search), 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 Financial Update
Recent leadership appointments, including Richard Stewart as CEO and Thomas King as Executive Chairman, highlight Achieve's commitment to strategic growth. As of September 30, 2024, the company’s cash, cash equivalents, restricted cash, and short-term investments totaled $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.
The Need for New Treatments
According to the World Health Organization, tobacco use is responsible for more than eight million deaths worldwide annually. In the United States, smoking (search) accounts for nearly half a million deaths each year. Achieve aims to address this critical public health issue with cytisinicline, a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor (search). 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.