Highlightll’s - Ummm, how much are we actually worth? TYK2 /Jak128 Mar 2023 16:03
Highlightll Pharmaceutical TLL-018 Achieved Breakthrough Results in a Phase II Trial for Rheumatoid Arthritis
January 29,2023 From:Highlightll Pharmaceutical
We are pleased to announce that TLL-018, the world's first highly selective dual TYK2/JAK1 inhibitor, has reached the intended endpoint in a Phase II clinical trial in patients with active rheumatoid arthritis conducted by 15 clinical centers across China and led by Professor Xiaofeng Zeng of Peking Union Medical Hospital, Chinese Academy of Medical Sciences. This study is a randomized, double-blind, head-to-head comparison with tofacitinib. The primary endpoint is the proportion of
patients with ACR50* after 12 weeks of treatment. The results showed that after 12 weeks of treatment, the ACR50 rates in the high, middle, and low dose groups of TLL-018 were higher than that in the tofacitinib group, and the efficacy improvements in the middle and high dose groups over tofacitinib reached statistical significance. Safety was similar across the four groups in this short study. Detailed data will be presented at an international scientific
conference soon.
Professor Zeng commented that this study used a bold and innovative design. Traditionally, csDMARDs* or placebo is used as control and ACR20* as the primary endpoint. This study used tofacitinib as the positive control and a higher standard of efficacy ACR50 as the primary endpoint, which showed Highlightll's confidence in the drug. The preliminary results of the study suggest that the dual TYK2/JAK1 inhibitor TLL-018 may have efficacy advantages over tofacitinib. We look forward to confirming the efficacy and safety of TLL-018 in a large phase IlI trial, providing a
good option for patients with rheumatoid arthritis. Highlightll is communicating with the Center for Drug Evaluation (CDE) of the National Medical Products Administration in China to conduct Phase III registration
studies. Hangzhou Highlight Pharmaceutical Co., Ltd. is an innovative drug development company focusing on the research and development of small molecules for the
treatment of autoimmune/inflammatory diseases and central nervous system diseases. The company's leading project, a TYK2/JAK1 dual inhibitor, is being studies in multiple clinical trials in China and US. The company is headquartered in Hangzhou,
with branches in Beijing, Shanghai and Wuhan and a subsidiary in New Jersey, USA. "ACR20 and ACR50 are the rheumatoid arthritis disease scoring standards developed by the American College of Rheumatology, which indicate a disease improvement of more than 20% or 50%, respectively. *esDMARDs is conventional
synthetic disease-modifying antirheumatic drugs.