GENFIT's candidate drug elafibranor for primary bile ductitis 2 study yielded positive results
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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Pharmaceutical(http://company(http://GENFIT announced positive results from the company's candidatedrug(http://elafibranor for the treatment of primary biliary biliary itisis (PBC)ElafibranorElafibranor is a leading candidate in genFIT'sproduct(http://lineThe drug is an oral, daily treatment and is the first candidate drug to be used for non-alcoholic fatty hepatitis (NASH) therapy by activating receptor alpha/alpha/sepsis (PPAR/s) through peroxidase proliferationElafibranor is thought to solve many aspects of NASH' problems, including inflammation, insulin sensitivity, lipid/metabolic characteristics, and liver markersthe study the trial (http:// a multicenter (U.S and Europe) study using double-blind, randomized, placebo-controlled, 12 weeks to evaluate the efficacy and safety of elafibranor (80 mg and 120 mg per day) for treatment of adult PBC patients with insufficient relief for bear deoxycholic acid (UDCA) the study reached the main endpoint - changes in serum alkaline phosphatase (ALP) from baseline to week 12 ALP is an alternative marker of identified PBC disease progression, and this composite endpoint has previously been used for regulatory approval results showed a significant reduction in the average ALP of both elafibranor doses: -48% (80 mg), -41% (120 mg), 3% increase in placebo, and had a very significant therapeutic effect compared to placebo (-52%, 80 mg, p0.001) and (44%, 120 mg, p 0.001) the critical secondary endpoint scored reached the compound endpoint (sero-ALP 1.67xULN, ALP decreased by 15%, total bilirubin (TB) ULN) patients' remission rate At this point, Elafibror 80 mg has an effective rate of 67%, 120 mg is 79%, and placebo is 6.7% (p-0.001 and p 0.001, respectively) in the alafibranor treatment group, patients showed other PBC markers such as total cholesterol, ldl-glutamate and triagon studies have observed an improvement in itching and will be confirmed in a longer-lasting study Elafibranor treatment was usually well tolerated, and the treatment group and placebo group had similar adverse reactions
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