Genfit to Test Nangibotide Against Acute Decompensation of Cirrhosis
After acquiring nangibotide during summer 2026, Genfit plans to evaluate this drug candidate in acute-on-chronic liver failure (ACLF).
The Lille-based company is relying on data from trials conducted in other indications to directly initiate a proof-of-concept study.
A Summer Acquisition Integrated into the Hepatic Portfolio
Genfit announced on September 14, 2026 its intention to evaluate nangibotide as part of a phase 2 study for the treatment of acute decompensation of cirrhosis, designated by the English term Acute-on-Chronic Liver Failure (ACLF).
This drug candidate was acquired by the company during summer 2026. It acts on the TREM-1 signaling pathway, targeted in several acute inflammatory pathologies.
According to the group, the nangibotide dossier comprises a set of safety data based on experience gained from over 400 subjects suffering from various acute inflammatory conditions. This data set could enable it to move directly to a proof-of-concept evaluation in ACLF.
Pascal Prigent, Chief Executive Officer of Genfit, stated: "We believe that ACLF represents one of the most significant unmet medical needs in the field of liver diseases. Nangibotide could demonstrate strong strategic coherence with our portfolio and further reinforces our position as a leader in this area."
The company notes that regulatory and CMC (Chemistry, Manufacturing and Controls) dossiers relating to nangibotide are well advanced, which could facilitate rapid clinical development in this indication.
Efficacy Signals Observed in Septic Shock and COVID-19
Nangibotide was the subject of three phase 2 clinical trials conducted in patients with septic shock and COVID-19.
In post hoc analyses, the molecule demonstrated several efficacy signals, including a statistically significant reduction in mortality in patients with severe forms of COVID-19. Significant improvements in SOFA score compared to baseline values were also observed in patients with septic shock.
With regard to safety and tolerability, the company reports a favorable overall profile, demonstrated in four clinical trials including over 400 seriously ill patients who received nangibotide. According to the group, no notable differences compared to placebo were noted regarding safety criteria.
A Proof-of-Concept Study Expected by End of 2026
Genfit expects to initiate a phase 2a proof-of-concept clinical trial with nangibotide in ACLF during the fourth quarter of 2026, with results anticipated in 2027.
The company will provide further details at the Liver Meeting, to be held in Denver in November 2026.
Genfit is a biopharmaceutical company based in Lille, Paris and Cambridge (Massachusetts), listed on Euronext in Paris (Compartment B). In 2021, Ipsen became one of its principal shareholders with a stake of 8% in its capital.
