GENFIT Advances Nangibotide in Phase 2 Clinical Investigation in ACLF
- GENFIT's acquisition of nangibotide, a differentiated late-stage asset, reinforces the Company’s portfolio of innovative therapies addressing high unmet medical needs
- The investigation in Phase 2 is supported by a robust scientific and clinical foundation around the TREM-1 pathway and the asset's profile:
- Strong knowledge of nangibotide’s biological pathway
- Multiple efficacy signals already observed with nangibotide across three Phase 2 clinical trials in septic shock and COVID-19 subjects, including a statistically significant reduction in mortality in severe COVID-19 and significant improvements in SOFA score from baseline in septic shock
- Overall favorable safety and tolerability profile demonstrated across four clinical trials, with more than 400 subjects exposed to nangibotide, and no meaningful differences versus placebo in safety outcomes
- Nangibotide expected to enter a Phase 2a proof-of-concept study in ACLF in the fourth quarter of 2026, with data readout targeted in 2027
- More details to be disclosed during The Liver Meeting® in Denver, in November 2026
Lille (France), Cambridge (Massachusetts, United States), September 14, 2026 - GENFIT (Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced the strengthening of its pipeline through the acquisition of nangibotide in summer 2026, and its plan to investigate nangibotide in a Phase 2 clinical trial for the treatment of Acute-on-Chronic Liver Failure (ACLF).
A clinical and regulatory foundation supporting rapid development
Nangibotide has an extensive human safety package, built on experience from more than 400 subjects across acute inflammatory conditions, supporting the program to move directly into proof-of-concept evaluation in ACLF.
In the post-hoc analysis of Phase 2 clinical trials conducted in septic shock and COVID-19, nangibotide demonstrated multiple efficacy signals, including a statistically significant reduction in mortality.
The existing regulatory and CMC (Chemistry, Manufacturing, and Controls) packages for nangibotide are also well advanced to support rapid clinical development in ACLF, allowing the program to build on an extensive clinical safety database and a mature, well-established manufacturing platform.
Pascal Prigent, CEO of GENFIT, commented: “We believe ACLF represents one of the most significant unmet needs in liver disease. Nangibotide could be a strategic fit for our ACLF portfolio and further reinforces our leadership position in this field. We look forward to advancing the program toward proof of concept.”
Next steps
GENFIT expects to initiate a Phase 2 proof of concept trial in the fourth quarter of 2026, with data available in 2027. The Company will provide more details during The Liver Meeting ® in Denver, in November 2026.
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ABOUT GENFIT
GENFIT is a biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific heritage spanning more than two decades. Today, GENFIT focuses on Acute on-Chronic Liver Failure (ACLF) and associated conditions such as acute decompensation (AD) and hepatic encephalopathy (HE). It develops therapeutic assets which have complementary mechanisms of action, selected to address key pathophysiological pathways. GENFIT also targets other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorders (UCD) and organic acidemia (OA). Its R&D portfolio, covering several stages of development, ensures a constant news flow. GENFIT's expertise in developing high-potential molecules – from early to advanced pre-commercialization stages – culminated in 2024 with the accelerated approval of Iqirvo® (elafibranor) by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom for second-line treatment of Primary Biliary Cholangitis (PBC). Iqirvo® is now marketed in several countries.1 Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® for the detection of Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis). GENFIT, a BCorp™ certified company since 2025, is headquartered in Lille, France and has offices in Paris (France) and Cambridge, MA (USA). The Company is listed on the Euronext regulated market in Paris, Compartment B (Euronext: GNFT). In 2021, Ipsen became one of GENFIT's largest shareholders, acquiring an 8% stake in the Company's capital. www.genfit.com
FORWARD LOOKING STATEMENTS
This press release contains certain forward-looking statements with respect to GENFIT, including, but not limited to, statements regarding the development and potential therapeutic profile of nangibotide, the potential role of TREM-1 in Acute-on-Chronic Liver Failure (ACLF), the initiation, design, conduct, timing and results of future clinical trials, including the planned Phase 2a proof-of-concept study in ACLF, the potential clinical benefits, safety profile and therapeutic value of nangibotide, the potential relevance on future clinical investigations of efficacy signals and safety data observed in prior clinical studies conducted in other indications, the expected timing of data readouts, regulatory interactions and future development activities, as well as the Company's strategic plans and objectives. The use of certain words, such as "believe", "potential", "expect", “target”, “may”, “will”, "should", "could", "if" and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among others, the uncertainties relating to the successful integration and development of nangibotide following its acquisition by the Company; the ability to initiate and complete clinical trials within anticipated timelines; uncertainties associated with patient enrollment, site activation and trial execution; the possibility that clinical trial results may not support further development of nangibotide; safety findings that may emerge during future studies and; regulatory requirements, interactions and decisions and manufacturing and supply considerations. No assurance can be given that the planned Phase 2a study will demonstrate efficacy, safety, or clinical benefit, nor that nangibotide will ultimately receive regulatory approval for any indication. Those risks and uncertainties also include those discussed or identified in the Company’s public filings with the AMF, including those listed in Chapter 2 "Risk Factors and Internal Control" of the Company's 2025 Universal Registration Document filed on April 3, 2026 (no. 26-0221) with the Autorité des marchés financiers ("AMF"), which is available on GENFIT's website (www.genfit.fr) and the AMF's website (www.amf.org), and those discussed in reports filed with the AMF or otherwise made public, by the Company. In addition, even if the results, performance, financial position and liquidity of the Company and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this press release. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.
CONTACTS
GENFIT | Investors
Jean-Christophe Marcoux – Chief Corporate Affairs Officer | Tel: +33 3 2016 4000 |
jean-christophe.marcoux@genfit.com
Kevin Gardner – Life Science Advisors | kgardner@lifesciadvisors.com
GENFIT | Media
Bruno ARABIAN – Agence Maarc | Tel : 06 87 88 47 26 | bruno.arabian@maarc.fr
Stephanie Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com
GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | www.genfit.com
1 Elafibranor is marketed and commercialized, notably in the U.S and Europe, by Ipsen under the trademark Iqirvo®
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