Ai Sen completed a phase I clinical study of the new autoimmune disease treatment drug AC0058
Ai Sen completed a phase I clinical study of the new autoimmune disease treatment drug AC0058 June 20, 2017 Source: Essen Pharmaceuticals On June 14, 2017, Essen announced the completion of Phase I clinical study of AC0058. AC0058 is a novel small molecule inhibitor of irreversible Bruton's tyrosine kinase (BTK) for the treatment of B cell-associated autoimmune diseases, including systemic lupus erythematosus and rheumatoid arthritis. The Phase I clinical study of AC0058 was a placebo-controlled, double-blind trial in the United States that evaluated the safety of AC0058 in 56 healthy subjects by single-dose escalation (SAD) or 7-day multi-dose escalation (MAD) trials. , tolerance, pharmacokinetics, pharmacodynamics, and target effectiveness. The results of the study showed that AC0058 had good safety and tolerability, and both SAD and MAD tests reached the main evaluation endpoint and did not reach the maximum tolerated dose. “AC0058 is another important innovation of Essen after the development of the first third-generation EGFR inhibitor, eviatinib. In the past two years, Avitini has carried out clinical trials in China and the United States simultaneously. A good research result." Xu Xiao, chairman of Aisen Pharmaceuticals, said, "Aisen has a professional ability in the development of new drugs for tyrosine kinase inhibitors, so the development of AC0058 has been rapidly advanced. AC0058 is highly safe. Ideal for the treatment of chronic diseases of the autoimmune class. Based on the results of Phase I clinically encouraging studies and the characteristics of AC0058 for chronic oral administration, we are advancing the initiation of the AC0058 Phase II clinical trial. Essen will be at a future clinical meeting. Publish more test details and research results." AC0058 launched preclinical research in 2012, which is one of the major special projects for the creation of new drugs in the national “Twelfth Five-Year Planâ€. AC0058 was clinically approved by the US FDA in December 2015 and clinically approved by China CFDA in December 2016. If AC0058 can be successfully developed, it will be the first small-molecule BTK targeted innovation drug for systemic lupus erythematosus (first-in-class), achieving breakthroughs in the treatment of systemic lupus erythematosus with phosphokinase inhibitors. Beard Straight Comb,Straight Beard Comb,Men Hair Straightening Comb,Electric Straight Hair Beard Comb Shenzhen Jie Zhong Lian Investment Co., Ltd. , https://www.meizons.com