French pharmaceutical company Ipsen SA (IPSEY) and late-stage biopharmaceutical company GENFIT SA (GNFT) announced Friday positive topline data from the pivotal ELATIVE Phase III trial of elafibranor in patients with primary biliary cholangitis or PBC, a rare cholestatic liver disease.
The trial met primary endpoint with a statistically significant higher percentage of patients achieving a clinically meaningful cholestasis response compared to placebo.
Ipsen said it intends to submit regulatory applications for elafibranor following discussions with the U.S. Food and Drug Administration and the European Medicines Agency or EMA.
PBC is a rare, progressive, autoimmune cholestatic liver disease in which bile ducts in the liver are gradually destroyed. The damage to bile ducts can inhibit the liver’s ability to rid the body of toxins, and can lead to scarring of liver tissue, known as cirrhosis.
Elafibranor, a novel, oral, once-daily, dual peroxisome activated receptor (PPAR) alpha/delta (a,d) agonist, is currently under investigation as a treatment for patients with PBC. It was granted a Breakthrough Therapy designation by the FDA in adults with PBC in 2019. Elafibranor has not received approval by regulatory authorities anywhere in the world.
ELATIVE is a multi-center, randomized, double-blind, placebo-controlled Phase III clinical trial, with an open-label long-term extension (NCT03124108). ELATIVE is evaluating the efficacy and safety of elafibranor 80mg once daily versus placebo for the treatment of patients with PBC with an inadequate response or intolerance to UDCA, the existing first-line therapy for PBC.
The trial enrolled 161 patients who were randomized 2:1 to receive elafibranor 80mg once daily or placebo.
In the trial, the companies assessed the efficacy and safety of elafibranor, an investigational dual a,d PPAR agonist, for the treatment of patients with PBC, who have an inadequate response or intolerance to the current standard of care therapy, ursodeoxycholic acid or UDCA.
The trial met its primary composite endpoint, with 51% of patients on elafibranor 80mg achieving a cholestasis response compared with 4% on placebo.
The first secondary endpoint was also met with statistically significant improvements for investigational elafibranor compared with placebo.
The companies will present full data from the ELATIVE trial at a future scientific congress.
IPSEN is one of GENFIT’s largest shareholders and holds 8% of the company’s share capital.
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