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Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), December 6, 2023- GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced the publication in the Journal of Hepatology2 of a paper on the performance of NIS2+™ as a screening tool for the enrollment of patients in Metabolic Dysfunction–Associated Steatohepatitis (MASH) clinical trials.
The study highlights NIS2+™'s potential effectiveness to significantly reduce the number of liver biopsies required for the enrollment of patients in MASH clinical trials. The study demonstrates that, for 1,000 inclusions in a trial, NIS2+™ could significantly reduce the number of unnecessary liver biopsies being performed (632 vs 1,522; -58%). The data taken from this study indicate that NIS2+™ may reduce liver biopsy failure rate to <30% and that NIS2+™ alone performs better than FIB-4 alone (a non-invasive test for fibrosis detection) or combined with FIB-4.
In MASH clinical trials, patients are referred to liver biopsy for potential enrollment based on clinical and biological features that are neither sensitive nor specific, leading to unacceptably high (>60%) liver biopsy failure rates. Reducing liver biopsy failure rates using non-invasive tests represents a high unmet need and an important step towards accelerating recruitment at optimized cost in future MASH clinical trials.
Dr. Vlad Ratziu, Professor at Sorbonne University and Pitié-Salpêtrière Hospital in Paris, France, stated: "Most late-stage MASH trials do not have a well-defined, non-invasive strategy for referring patients to liver biopsy. There is a real need to maximize the accuracy of the patient selection process by using better non-invasive predictors of at-risk MASH. NIS2+™ has the potential to become an accessible and rapid screening tool that could have a major impact on the feasibility of MASH clinical trials, including the speed of enrollment."
Dr. Stephen Harrison, Chairman and Founder for Pinnacle Clinical Research, Chairman and Co-Founder of Summit Clinical Research, USA and Visiting Professor of Hepatology at the Radcliffe Department of Medicine, University of Oxford, UK, commented: "Screening patients with NIS2+ would potentially prevent unnecessary liver biopsies, reducing the likelihood of study related complications and improve patient satisfaction. It would also lead to a liver biopsy failure rate decrease, maintaining timely and cost-efficient completion of MASH clinical trials – a prerequisite for the testing of the numerous molecules currently in development."
A total of three papers on NIS2+™ technology have been published in leading medical journals this year. Six posters and two oral presentations featuring complementary data on the performance of NIS2+™ were also presented this year at key scientific conferences: NASH-TAG, EASL3, Paris-NASH and AASLD4 TLM.
ABOUT MASH
MASH is a liver disease characterized by an accumulation of fat (lipid droplets), along with inflammation and degeneration of hepatocytes. The disease is associated with an increased risk of cardiovascular disease along with long-term risk for progression to cirrhosis, leading to liver insufficiency and potential progression to liver cancer. MASH is a serious disease that often carries no symptoms in its early stages, but if left untreated can result in cirrhosis, cancer, and the need for liver transplant. The prevalence of MASH is rapidly increasing as a result of the growing obesity and diabetes epidemics and is believed to affect as much as 12 percent of people in the U.S. and six percent worldwide.
ABOUT NIS2+™
NIS2+™ is a blood-based diagnostic technology specifically designed to detect at-risk MASH among patients with metabolic risk factors based on an independent 2-biomarker panel. It is an optimization of the NIS4® technology and was developed and validated by GENFIT as a robust technology across characteristics of interest such as type-2 diabetes, age and sex, allowing large-scale implementation in clinical practice. GENFIT continues to explore the possibility of obtaining regulatory approval and CE Certificates of Conformity, for the widespread use an IVD test powered by NIS2+™ technology in both the United States and Europe.
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