Genfit's elafibranor is recognized by fda for treatment of PBC adult patients

Today, Genfit(http://announced that its flagshipproduct,(http://elafibranor, has been awarded a breakthrough therapy by the U.SFDA(http://for the treatment of primary bile bile bilirubitis (PBC) adult patientsElafibranor is a "first-in-class" PPAR alpha/nilip emothane that has shown positive efficacy in the treatment of PBC patients in the phase 2 clinicaltrial(http://, while treating non-alcoholic fatty hepatitis (NASH) patients in Phase 3 clinical trialsElafibranor is a dual agonist that activates both PPAR alpha and PPARThese two nuclear receptors mediate a variety of physiological processes, including fat metabolism, glucose metabolism balance, inflammation, and so onThe difference between Elafibranor and other PPAR receptor agonists is that it does not activate the PPAR receptorTherefore, it does not cause toxic side effects associated with PPAR receptor activation, such as weight gain, puffiness, and fluid retention, which may increase the patient's risk of cardiovascular disease 　　This breakthrough therapy was determined to be based on elafibranor's performance in Phase 2 clinical trials In a 12-week randomized double-blind, placebo-controlled Phase 2 trial, a total of 45 PBC patients without cirrhosis were treated with different doses of elafibranor or placebo who had a poor response to UDCA The main endpoint of the test was a change in the level of alkaline phosphatase (ALP) 　　The results showed that two different doses of elafibranor significantly reduced the patient's ALP level slower than the placebo AlP levels decreased by 52% (p.0.001) in patients with a dose of 80 mg in the elafibranor group and 44% (p0.001) in patients with a dose of 120 mg other PBC-related biomarker indicators in elafibranor group also improved significantly, including pyridine-glutathant (GGT) levels, and biomarker levels