China-based Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd) has announced the enrollment of the first patient in a global pivotal clinical study for its pipeline candidate, ABP-671. This small molecule inhibitor of the urate transporter 1 (URAT1) protein plays a crucial role in the reabsorption of uric acid by the kidneys, offering a potential new treatment for gout patients by reducing uric acid levels.
Study Design and Objectives
The multi-center, randomized, double-blinded Phase III study is designed to assess the safety and efficacy of ABP-671 in gout patients under various dosages and regimens, with the goal of enrolling 580 patients worldwide. This trial represents a significant step in advancing the drug’s development and potential approval for gout treatment.
Positive Phase II Results
In a previous Phase II clinical study, ABP-671 demonstrated positive efficacy and safety when administered once daily at doses ranging from 1mg to 12mg. Notably, the efficacy of a single daily administration of 2mg was found to be equivalent to or superior to the highest dose of 80mg of benzbromarone and febuxostat, two standard treatments for gout. The study achieved clinical treatment endpoints with 100% of subjects in the 6mg and 8mg dose groups reaching sUA levels of <6 mg/dL, and subjects in the 12mg high-dose group achieving sUA levels of <4 mg/dL after a single administration.
Safety and Efficacy Profile
No significant safety issues were observed for ABP-671, which exhibited a lasting efficacy around the clock. These results suggest that ABP-671 has the potential to offer a safe and effective treatment option for gout patients, with the convenience of once-daily administration.
Conclusion
The initiation of the global Phase III clinical study for ABP-671 by Atom Bioscience marks a significant milestone in the development of this novel gout treatment. With its promising efficacy and safety profile, ABP-671 could become an important therapeutic option for patients suffering from gout, potentially improving their quality of life and managing their condition more effectively.-Fineline Info & Tech
