GENFIT Showcases ACLF Pipeline Advances at AASLD 2025 with Three Novel Therapeutic Programs
核心洞察
GENFIT will present new preclinical data on three ACLF therapeutic programs at AASLD 2025, including G1090N (nitazoxanide reformulation), SRT-015 (ASK1 (搜索) inhibitor), and CLM-022 (NLRP3 inflammasome (搜索) inhibitor).
The company's lead ACLF program G1090N is expected to deliver clinical safety data and early efficacy markers by the end of 2025.
Partner Ipsen will present additional data on Iqirvo (elafibranor) from ongoing studies in primary biliary cholangitis (搜索) and primary sclerosing cholangitis (搜索).
GENFIT announced its comprehensive participation at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2025 in Washington, D.C., November 7-11, 2025, featuring new data across its Acute on-Chronic Liver Failure (搜索) (ACLF) pipeline and partner presentations on rare cholestatic liver diseases.
Three ACLF Programs Show Preclinical Promise
The biopharmaceutical company will present preclinical data on three distinct ACLF therapeutic programs, each targeting different pathophysiological pathways of the life-threatening condition.
G1090N, a reformulation of nitazoxanide and GENFIT's lead ACLF program, will be featured in Poster #4165 demonstrating efficacy on systemic inflammation and organ function in ACLF disease models when administered post-ACLF trigger. The company expects to report clinical safety data and markers of early efficacy for G1090N by the end of 2025.
SRT-015, an ASK1 (搜索) inhibitor, showed promise in reducing systemic inflammation while promoting immune host defense mechanisms in preclinical in vitro and in vivo models related to ACLF, according to Poster #4171.
CLM-022, an inhibitor of the NLRP3 inflammasome (搜索), demonstrated efficacy in both in vivo and in vitro Pathogen-Associated Molecular Patterns (PAMPs)-induced disease models, as detailed in Poster #4565.
Real-World Evidence Highlights Management Challenges
GENFIT will present several studies addressing current challenges in ACLF patient care and diagnosis. An oral presentation (#0086) will characterize patients admitted to US hospitals for acute decompensation events, highlighting differences in inpatient management approaches.
Additional research will examine the impact of bacterial infection on clinical outcomes in patients with acute decompensation, providing real-world evidence insights. A distinguished poster and oral presentation (#4127) will address systemic challenges in managing ACLF in the U.S., including diagnostic delays, referral barriers, and fragmented post-discharge care.
Biomarker Research for Cirrhosis Detection
The company will present biomarker research focusing on diagnostic and prognostic tools for cirrhosis (搜索). Two distinguished posters will showcase the performance of single circulating biomarkers sVCAM-1 and TSP2 for detecting fibrosis progression to cirrhosis, and their combination with FIB-4 for improved patient detection.
Partner Data on Rare Cholestatic Diseases
Ipsen, GENFIT's partner, will present six abstracts from the ongoing Iqirvo (elafibranor) ELATIVE study in Primary Biliary Cholangitis (搜索) (PBC), including two late-breaking presentations and one abstract in Primary Sclerosing Cholangitis (搜索) (PSC). The data continue to support Iqirvo's efficacy and safety profile in modifying disease progression while improving key symptoms including fatigue and pruritus in PBC patients.
Data from the elafibranor ELMWOOD Phase 2 study will provide insights into the sustained efficacy and tolerability profile of elafibranor 120mg in PSC patients.
Company Focus and Pipeline
GENFIT focuses on ACLF and associated conditions such as acute decompensation and hepatic encephalopathy, developing therapeutic assets with complementary mechanisms of action. The company also targets cholangiocarcinoma (搜索), urea cycle disorders (搜索), and organic acidemia.
The company's expertise culminated in 2024 with the accelerated approval of Iqirvo (elafibranor) by the FDA, EMA, and MHRA for Primary Biliary Cholangitis (搜索) treatment. Iqirvo is now marketed in several countries by partner Ipsen.
GENFIT will organize two ACLF-focused events during the conference: ACLF Insights on November 7, 2025, and ACLF Patient Advocacy Council on November 9, 2025.