Core Insights - GENFIT is advancing its Acute on-Chronic Liver Failure (ACLF) pipeline with new clinical trials set to launch in early 2025, aiming for multiple data readouts by the end of the year [1][2][6] Clinical Trials and Data Readouts - Two new clinical trials are expected to initiate in the first quarter of 2025, focusing on VS-01 and G1090N, a new formulation of NTZ [2][6] - A total of four clinical data readouts are anticipated by the end of 2025, including results from the ongoing UNVEIL-IT® Phase 2 trial and the GNS561 Phase 1b trial in cholangiocarcinoma [2][10] - The first trial will be a proof-of-concept study for VS-01, while the second will confirm the commitment to NTZ with G1090N [5][8] Strategic Development and Insights - The design of the new trials is informed by real-world evidence from over 270,000 U.S. patients, which has provided insights into ACLF risk profiles and management practices [2][7] - The trials will include a subset of patients with acute decompensation (AD) at high risk of progressing to ACLF, broadening the inclusion criteria to address both stages of the disease [3][4] - The integrated approach aims to facilitate faster patient recruitment and a more efficient assessment of drug candidates' therapeutic potential [3][4] Collaboration and Expert Insights - Collaboration with academic partners and insights from key opinion leaders (KOLs) have shaped the strategic direction of the ACLF pipeline [7][4] - KOLs emphasize the importance of including high-risk patients in clinical trials due to their rapid transition between AD and ACLF [4][5] Financial Outlook - GENFIT has announced a strengthened financial outlook, which, along with the anticipated clinical developments, positions the company for robust operations in the coming years [2][10]
GENFIT Outlines Anticipated New Clinical Trial Initiations, Development Milestones and Data Readouts in 2025