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Ipsen SA (OTC:IPSEY) and Genfit SA (NASDAQ:GNFT) announced topline data from the Phase 3 ELATIVE trial evaluating the efficacy and safety of elafibranor for primary biliary cholangitis (PBC) who have shown inadequate response or intolerance to ursodeoxycholic acid (UDCA), the current standard therapy.
PBC is a chronic disease in which the bile ducts in the liver are slowly destroyed.
The trial met its primary composite endpoint, with 51% of patients on elafibranor 80mg exhibiting a cholestasis response compared to 4% on placebo.
Cholestasis occurs when the flow of bile from the liver is reduced or blocked. Bile is fluid produced by the liver that aids in the digestion of food, especially fats.
Cholestasis response is characterized by a specific level and decrease of alkaline phosphatase (ALP) and total bilirubin (TB) ≤ ULN at 52 weeks.
A significant improvement in the normalization of ALP at Week 52 was observed as the first secondary endpoint, indicating the efficacy of elafibranor.
While a trend towards pruritus (itching) improvement was observed, it did not reach statistical significance.
The study revealed that elafibranor was generally well-tolerated with a consistent safety profile as in previous studies.
Ipsen plans to discuss these results with regulatory bodies and aims to move forward with regulatory submissions to the FDA and the European Medicines Agency.
In September last year, Genfit acquired the Swiss startup Versantis for CHF40 million upfront in a small-time buyout to expand its portfolio in liver diseases.
Price Action: GNFT shares are down 14.30% at $3.47 on the last check Friday.
