2023-06-30 08:16:55
French biopharmaceutical companies Ipsen and Genfit on Friday announced positive results from the latest stage of a clinical study evaluating a treatment for a rare liver disease that is one of the leading causes of liver transplantation.
This phase 3 trial, the last step before a potential commercialization, aimed to evaluate the efficacy and safety of elafibranor, a drug once morest primary biliary cholangitis (PBC), an autoimmune disease in which the bile ducts of the liver are gradually destroyed.
The study “met the primary endpoint, with a statistically higher percentage of patients who observed a clinically significant change in cholestasis (decreased or stopped bile secretion) compared to placebo,” say the partners in a communicated.
In detail, 51% of patients on elafibranor 80 mg achieved an improvement in cholestasis, in response to treatment compared to 4% on placebo, and the treatment was generally well tolerated, the statement said.
Elafibranor, which has not received any regulatory approval worldwide to date, “may become an important treatment option for the long-term treatment of patients with this disease,” says Howard Mayer, director of Ipsen Research and Development, quoted in the text.
Ipsen intends to discuss these results with regulatory authorities and to submit regulatory applications for elafibranor soon to the United States Medicines Agency (FDA) and the European Medicines Agency.
Common symptoms of PBC include general tiredness and itching which can be particularly debilitating.
If left untreated, PBC, which affects women significantly more than men, can lead to liver failure or, in some cases, death.
Ipsen and Genfit signed an agreement at the end of 2021 granting Ipsen an exclusive license to develop, manufacture and commercialize Genfit’s investigational drug elafibranor.
In return, Genfit, following an initial payment of 120 million euros, is “eligible to receive additional payments of up to 360 million euros”, as well as staggered, double-digit royalties of up to 20%, under the terms of the agreement.
Three years ago, the French biotech specializing in the field of liver disease, reported “very disappointing” results for its star drug candidate, elafibranor, in a phase III clinical study to treat the “human fatty liver disease” or Nash, a chronic disease closely linked to obesity.
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