GENFIT is set to present updates on its Primary Biliary Cholangitis (PBC) and Acute-on-Chronic Liver Failure (ACLF) programs at The Liver Meeting 2024. The company's partner, Ipsen, is making significant progress with Iqirvo® (elafibranor) for PBC, while GENFIT advances its ACLF franchise with new preclinical data and planned clinical studies. The company also plans to present new data on NIS2+® as a monitoring tool for patients with MASH.
PBC Program Update
Ipsen reported positive commercial and regulatory developments for Iqirvo® (elafibranor) in the U.S. and Europe. The U.S. launch is progressing as expected following FDA approval on June 10, 2024. EMA approval was received on September 20, 2024, and UK MHRA approval on October 9, 2024, followed by UK NICE approval on October 22, 2024. Recent reimbursement in Germany and the UK brings GENFIT closer to a €26.5M milestone payment, pending a third pricing and reimbursement approval in a major European country.
ACLF Franchise Developments
GENFIT will present preclinical data on its ACLF franchise at The Liver Meeting 2024. The presentations include:
- VS-01: Effect of VS-01 on Acute-on-Chronic Liver failure-related toxins such as lipopolysaccharide and hydrophobic bile acids in vitro (poster #1603)
- SRT-015: Intravenous administration with the ASK1 inhibitor SRT-015 alleviates liver injury and systemic inflammation in disease models of liver failure (poster #1597)
- CLM-022: Investigational drug CLM-022, a potent inhibitor of NLRP3 inflammasome-mediated pyroptosis, as a potential treatment for acute and chronic inflammatory liver diseases (poster #2232)
- NTZ: Efficacy of Nitazoxanide (NTZ) in Pathogen-Associated Molecular Patterns (PAMPs)-induced disease models (poster #2222)
GENFIT will also lead three key events on ACLF, including an ACLF KOL Advisory Board, an ACLF Patient Advocacy Council, and an ACLF Morning Insights session.
UNVEIL-IT Trial Update
The results from the UNVEIL-IT Phase 2 trial evaluating VS-01 in ACLF are now expected in the second half of 2025. The protocol was modified to improve recruitment and trial design. Inclusion and exclusion criteria were revised to better accommodate patient comorbidities, and enhanced storage flexibility for study material was introduced to clinical trial centers. GENFIT is also developing an innovative medical device to streamline the reconstitution process.
Data Readout Anticipated by End of 2025
GENFIT anticipates data readout from four clinical trials by the end of 2025. This includes the Phase 2 data for the UNVEIL-IT trial and data from three new clinical trials expected to launch in the first half of 2025, evaluating VS-01 and NTZ, alongside a First-in-Human study for SRT-015 with GENFIT’s formulation.
GNS561 in KRAS-mutated Cholangiocarcinoma
The phase 1b/2a clinical trial is currently ongoing and preliminary data from Phase 1b is targeted by the end of 2024. Final data is expected by the end of 2025.
NIS2+® in MASH
GENFIT will present new data on NIS2+®’s efficacy as a monitoring tool for patients with MASH at The Liver Meeting 2024. The presentations include:
- NIS2+, an effective monitoring tool for tracking disease evolution in patients with fibrotic MASH (poster #2062)
- NIS2+, an effective tool for monitoring MASH resolution and fibrosis improvement in patients with at-risk MASH (poster #2063)
- Detecting MASH resolution and fibrosis improvement with NIS2+ in patients with at-risk MASH (poster #2067)
