FDA grants CymaBay Therapeutics Clinical Phase 3 In Research Drug Seladelpar Breakthrough Therapy Determination

primary bile bile ductitis is a potentially life-threatening liver autoimmune diseaseAs the immune system continues to attack bile ducts, bile flow is blocked and silted, toxic bile acid remains in the liver, can develop liver fibrosis, cirrhosis and liver failurerecently, the U.SFDA(http://granted CymaBay Therapeutics(http://clinical 3 clinical drug Seladelpar breakthrough therapy, used in combination with bear deoxycholic acid (ursodeoxylic acid, UDCA) to treat uDCA under-reacted to the primary bile bile bile ductitis (PBC) adult patients, as well as as monotherapy treatment can not tolerate adult patients with monotherapy can not be tolerated in adult sAbout the seladelparin the clinical development stage of the seladelpar belongs to the powerful selective peroxidase proliferation activation receptor (PPAR) agonistPPAR is expressed in a variety of cell types in the liver, and preclinical data show that it regulates a variety of genesthe process ofof bile acid symoldering (http://, inflammation, and fibrosisIn addition to the treatment of PBC, CymaBay is also conducting phase 2b clinicaltrial(http:// using seladelpar to treat non-alcoholic fatty hepatitis (NASH) patients 　　Currently, CymaBay is recruiting patients who do not respond to UDCA or are intolerant of UDCA for the global Phase 3 study of the delladelpar treatment of PBC randomized, placebo-controlled, Phase 3 clinical study, called ENHANCE, will assess the safety and effectiveness of seladelpar, with the proportion of patients measured after 52 weeks as the primary endpoint An answer is considered to be generated if the patient's alkaline phosphatase (AP) level is 1.67 times below the normal upper limit, more than 15% lower than the baseline, and the total bilirubin level is normal