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Yes it’s a bit long! Hehehe! But some dates that could serve as upcoming catalysts!
$Genfit (GNFT.US)$ GENFIT at The Liver Meeting 2024
GENFIT will present pre-clinical data as part of its ACLF franchise with the following posters:
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 3 key events on ACLF:
ACLF KOL Advisory Board (November 14, 2024), bringing together 9 leading experts from Europe and the United States
ACLF Patient Advocacy Council (November 16, 2024), with the participation of Professor Debbie Shawcross, MBBS PhD FRCP, Professor of Hepatology and Chronic Liver Failure, Institute of Liver Studies King's College London, UK and EASL Vice-Secretary), the Global Liver Institute (GLI), the European Liver Patients' Association (ELPA), and real-life patients and caregivers
ACLF Morning Insights session (November 17, 2024), focused on addressing unmet needs, diagnostics, and guidelines for ACLF, with Dr. Jasmohan Bajaj, Professor of Medicine in the Division of Gastroenterology, Hepatology and Nutrition at Virginia Commonwealth University and Richmond VA Medical Center in Richmond, Virginia, USA. The event will also offer an intensivist's perspective with Dr. William Bernal, Professor of Liver Critical Care Medicine in the Liver Intensive Therapy Unit at the Institute of Liver Studies at King's College Hospital, London and Member of the EASL-CLIF Consortium Steering Committee. It will also outline GENFIT's clinical roadmap and highlight the patient and caregiver experience, via GLI and ELPA.
Key strategic insights and emerging trends uncovered through unique sources and channels
Over the last 12 months, GENFIT has made strides in understanding the ACLF continuum, enriching our body of knowledge compared to the knowledge available in the field at the time of our pivot to ACLF.
Key takeaways derived from these workstreams will inform the design of on-going and upcoming trials evaluating VS-01, NTZ and SRT-015. These insights will also help further strategize the research and clinical development of CLM-022 and VS-02-HE.
GENFIT will present pre-clinical data as part of its ACLF franchise with the following posters:
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 3 key events on ACLF:
ACLF KOL Advisory Board (November 14, 2024), bringing together 9 leading experts from Europe and the United States
ACLF Patient Advocacy Council (November 16, 2024), with the participation of Professor Debbie Shawcross, MBBS PhD FRCP, Professor of Hepatology and Chronic Liver Failure, Institute of Liver Studies King's College London, UK and EASL Vice-Secretary), the Global Liver Institute (GLI), the European Liver Patients' Association (ELPA), and real-life patients and caregivers
ACLF Morning Insights session (November 17, 2024), focused on addressing unmet needs, diagnostics, and guidelines for ACLF, with Dr. Jasmohan Bajaj, Professor of Medicine in the Division of Gastroenterology, Hepatology and Nutrition at Virginia Commonwealth University and Richmond VA Medical Center in Richmond, Virginia, USA. The event will also offer an intensivist's perspective with Dr. William Bernal, Professor of Liver Critical Care Medicine in the Liver Intensive Therapy Unit at the Institute of Liver Studies at King's College Hospital, London and Member of the EASL-CLIF Consortium Steering Committee. It will also outline GENFIT's clinical roadmap and highlight the patient and caregiver experience, via GLI and ELPA.
Key strategic insights and emerging trends uncovered through unique sources and channels
Over the last 12 months, GENFIT has made strides in understanding the ACLF continuum, enriching our body of knowledge compared to the knowledge available in the field at the time of our pivot to ACLF.
Key takeaways derived from these workstreams will inform the design of on-going and upcoming trials evaluating VS-01, NTZ and SRT-015. These insights will also help further strategize the research and clinical development of CLM-022 and VS-02-HE.
Data readout from 4 clinical trials anticipated by the end of 2025
Building on insights from the upcoming KOL Advisory Board and additional real-world evidence anticipated by late November 2024, GENFIT will finalize the design of two new proof-of-concept studies evaluating VS-01 and NTZ, alongside a First-in-Human study for SRT-015 with GENFIT's formulation. These trials are expected to launch in the first half of 2025, with data readouts expected by year-end.
With Phase 2 data for UNVEIL-IT trial also anticipated by the close of 2025, GENFIT will deliver four clinical data sets in 2025, advancing three clinical-stage assets of our ACLF pipeline in parallel.
Preclinical assets
CLM-022: Preclinical Proof of Concept expected to be obtained by end of 2024
VS-02-HE: Completion of Investigational New Drug (IND) enabling studies expected in 2025
III. 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.
IV. NIS2+® in MASH
During The Liver Meeting 2024, GENFIT will also present new data on NIS2+®'s3 efficacy as a monitoring tool for patients with MASH12 with the following posters:
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)
Building on insights from the upcoming KOL Advisory Board and additional real-world evidence anticipated by late November 2024, GENFIT will finalize the design of two new proof-of-concept studies evaluating VS-01 and NTZ, alongside a First-in-Human study for SRT-015 with GENFIT's formulation. These trials are expected to launch in the first half of 2025, with data readouts expected by year-end.
With Phase 2 data for UNVEIL-IT trial also anticipated by the close of 2025, GENFIT will deliver four clinical data sets in 2025, advancing three clinical-stage assets of our ACLF pipeline in parallel.
Preclinical assets
CLM-022: Preclinical Proof of Concept expected to be obtained by end of 2024
VS-02-HE: Completion of Investigational New Drug (IND) enabling studies expected in 2025
III. 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.
IV. NIS2+® in MASH
During The Liver Meeting 2024, GENFIT will also present new data on NIS2+®'s3 efficacy as a monitoring tool for patients with MASH12 with the following posters:
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)
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