Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as ‘Lynk Pharmaceuticals’), an innovative clinical stage company, announced that it has dosed the first patient with Rheumatoid Arthritis (RA) in a Phase Ⅲ clinical trial of its highly selective JAK1 inhibitor LNK01001.
The clinical study is a randomized, double-blind, placebo-controlled Phase III trial evaluating the efficacy and safety of LNK01001 in the treatment of moderate to severe active rheumatoid arthritis with inadequate response or intolerant to bDMARDs. The trial is led by Professor Xiaofeng Zeng from Peking Union Medical College Hospital and Chinese Academy of Medical Sciences. With the strong support and assistance of its commercialization partner, Simcere Pharmaceutical Group Limited (“Simcere”), Lynk Pharmaceuticals will conduct the study at multiple clinical research centers nationwide.
LNK01001 is a potentially best-in-class, highly selective JAK1 inhibitor. Three Phase II clinical studies in patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), and atopic dermatitis (AD) were completed prior to this Phase III trial. To date, LNK01001 has been administered in over 800 subjects globally, including approximately 100 subjects in a Phase I trial conducted in Australia and over 600 patients with rheumatoid arthritis, ankylosing spondylitis, or atopic dermatitis in China. All completed Phase II studies have successfully achieved their respective primary and secondary clinical endpoints and demonstrated excellent overall safety, with no observed major adverse cardiovascular events, thrombosis, severe infections, or malignancy associated with other JAK inhibitors, showcasing the best potential among similar drugs.
Lynk Pharmaceuticals entered into a strategic commercial partnership with Simcere for LNK01001 in March 2022. Simcere gained the exclusive commercial rights to market LNK01001 for the indications of rheumatoid arthritis and ankylosing spondylitis in the greater China.
Dr. Henry Wu, Chief Development Officer of Lynk Pharmaceuticals, said, ” Rheumatoid arthritis is a chronic, progressive autoimmune disease that significantly impacts patients’ quality of life and physical health. In the Phase II clinical trials of LNK01001, we observed positive efficacy and good safety. Moving forward, we will actively advance the clinical research to bring a new treatment option to patients as soon as possible.”
“The successful dosing of the first patient with LNK01001 in its Phase III study for the treatment of rheumatoid arthritis is an important milestone for our team and a key step towards providing innovative treatment options for patients with rheumatoid arthritis,” Dr. Zhao-Kui (ZK) Wan, Chairman and CEO of Lynk Pharmaceuticals, said, “We believe that the Phase III clinical trial of LNK01001 will further validate its efficacy and safety. We hope to have an opportunity to offer patients a better treatment option to improve their quality of life.”