GENFIT has presented new clinical and scientific data supporting the development of nangibotide in acute-on-chronic liver failure (ACLF), with a phase 2a proof-of-concept study expected to begin before the end of 2026 and top-line data anticipated in the second half of 2027.
The biopharmaceutical company unveiled the findings during a scientific meeting of leading ACLF experts held alongside AASLD The Liver Meeting in Denver.
Nangibotide is GENFIT’s lead investigational asset for ACLF, a severe condition characterised by systemic inflammation and multi-organ dysfunction. The therapy is designed to modulate triggering receptor expressed on myeloid cells-1 (TREM-1), an amplifier of inflammation, with the aim of reducing excessive inflammatory responses without directly affecting immune recognition.
According to the company, activation of the TREM-1 pathway has been linked to progression from acute decompensation to ACLF and is associated with disease severity and poor outcomes.
GENFIT highlighted safety and efficacy findings generated across previous phase 2 studies of nangibotide in septic shock and COVID-19, involving a total of 416 exposed subjects.
The company reported an overall safety profile comparable to placebo and no identified safety signals. In a subgroup of 118 septic shock patients with elevated soluble TREM-1 levels, nangibotide was associated with a greater reduction in Sequential Organ Failure Assessment score compared with placebo, alongside favourable trends in mortality and other clinical outcomes.
In a separate study involving 219 patients with COVID-19, treatment with nangibotide was associated with improved clinical status and lower day 28 mortality.
Professor Jennifer C. Lai, Endowed Professor of Liver Health & Transplantation at the University of California, San Francisco, said: “The unmet need in ACLF remains tremendous, particularly for patients in the ICU who can rapidly progress to multi-organ failure.”
She added: “What is especially exciting about nangibotide is that we are not starting from scratch: the program already benefits from substantial phase 2 clinical experience and proof-of-concept in acute inflammatory conditions characterized by organ dysfunction.”
Lai continued: “This gives us a rare opportunity to bring an already extensively studied clinical-stage candidate into ACLF and explore whether those signals can translate into meaningful benefit for these critically ill patients.”
