GENFIT (NASDAQ:GNFT) shares fell 5% after initially rising on positive results from its clinical trial with partner Ipsen for the investigational therapeutic elafibranor in patients with the rare cholestatic liver disease primary biliary cholangitis (PBC).
The two companies announced on Friday that the Phase 3 ELATIVE trial met its primary endpoint with a statistically significant higher percentage of patients achieving a clinically meaningful cholestasis response compared to the placebo. 51% of patients on elafibranor 80mg achieved a cholestasis response compared to 4% on placebo.
Elafibranor was also well tolerated with a safety profile consistent with previous studies, the companies noted.
Following discussions with the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), Ispen intends to submit regulatory applications for elafibranor.
“We are pleased by these results because PBC remains a disease where significant unmet medical needs exist,” commented GENFIT (NASDAQ:GNFT)'s CEO Pascal Prigent.
“This long-awaited trial outcome is therefore good news for patients and for healthcare professionals who need more options to improve the clinical management of patients with PBC.”
Shortly after the market open on Friday, Genfit was trading down 5.1% at US$3.93. Ipsen’s European-listed shares were modestly lower, down 0.2% at €110.40.
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