The clinical study is designed to evaluate the safety and efficacy of LNK01001 in subjects with moderate to severe active rheumatoid arthritis who have poor response with or intolerance to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs).
LNK01001 is the first innovative drug developed by Lynk Pharmaceuticals, and is a selective kinase inhibitor for the treatment of autoimmune diseases. Previously, LNK01001 completed Phase I clinical studies in healthy subjects in the summer of this year in China and in Australia and Japan, sponsored by Lynk Pharmaceuticals and its US partner, respectively. The results demonstrated that the drug is safe and well tolerated. In addition, LNK01001 was approved by the National Medical Products Administration of China (NMPA) for the clinical evaluation of new indications — ankylosing spondylitis (AS) and atopic dermatitis (AD).
Professor Xiaofeng Zeng is the principal investigator of this study and the director of the Department of Rheumatology and Immunology of Peking Union Medical College Hospital and Chinese Academy of Medical Sciences.