Ipsen S.A. (OTCMKTS: IPSEY) and Genfit S.A. (Nasdaq: GNFT) have announced positive results from the ELATIVE Phase III trial evaluating elafibranor as a treatment for patients with primary biliary cholangitis (PBC), a rare cholestatic liver disease, who do not respond well or cannot tolerate the current standard therapy, ursodeoxycholic acid (UDCA).

The trial met its primary composite endpoint, with elafibranor 80mg showing a significant 51% cholestasis response compared to placebo's 4%. This was evidenced by reductions in alkaline phosphatase (ALP) levels and total bilirubin (TB), indicating improved liver function. Additionally, the trial demonstrated a normalization of ALP levels and a trend for pruritus improvement with elafibranor.

PBC is a rare liver disease that can lead to liver failure if left untreated. The results suggest that elafibranor could be a promising long-term treatment option for PBC patients who have an inadequate response to current therapies.

As part of the licensing agreement between the companies for elafibranor, GENFIT received €120m upfront in 2021 and is eligible to receive up to €360m in milestone payments as well as tiered double-digit royalties of up to 20% from Ipsen.

$GNFT was trading at $5.27 in pre-market, up $1.13 (+27.29%) following the announcement.

THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY OR DIGITAL ASSET. Please consult with a professional investment advisor before purchasing or selling any securities viewed on or mentioned herein. (Read Full Disclaimer)