GENFIT Announces Results of NIS4, an Investigational Non-Invasive NASH Diagnostic, at AASLD 2019
NIS4 is GENFIT’s innovative non-invasive in vitro diagnostic test, or IVD, to identify patients with NASH who may be appropriate candidates for drug therapy
Program is based on the in-house discovery of a 4-biomarker algorithm potentially replacing biopsy with a single blood test
Study finds patients living with type 2 diabetes are at increased risk of being diagnosed with NASH
Lille (France), Cambridge (Massachusetts, United States), November 10, 2019 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, today announced results from a study demonstrating NIS4, an innovative non-invasive diagnostic blood test designed to diagnose nonalcoholic steatohepatitis (NASH), outperformed other non-invasive diagnostics in identifying NASH in people with type 2 diabetes. These data will be presented at AASLD The Liver Meeting® 2019 in Boston today, November 10 from 12:30PM-1:30PM (Poster #1757).
The study titled, “Type 2 diabetes as a risk factor for NASH and fibrosis in a cohort of 2363 patients with suspicion of NAFLD: use of NIS4 for identification of at-risk NASH in diabetic patients” explores how type 2 diabetes is a risk-factor for NASH and liver fibrosis, and also compares the diagnostic performance of NIS4 vs other non-invasive blood marker-based scores in a population of patients with type 2 diabetes. Cohort 1 (N=820) assessed the influence of type 2 diabetes status and anti-diabetic treatment on the prevalence of NAS>4 and F>2, while cohort 2 (N=275) assessed the diagnostic performance of NIS4 in patients with type 2 diabetes.
The data show that of the patients in Cohort 1, the presence of type 2 diabetes is associated with increased prevalence of active NASH (NAS>4) and significant fibrosis (F>2), i.e. at risk of progression to serious liver outcomes. The probability of having NAS>4 with F>2 increases with the number of additional anti-diabetic therapies taken by patients to control their glycemia, irrespective of the antidiabetic drug classes used, whether insulin or non-insulin drugs. The data accentuate the need for active surveillance of liver injury in patients with type 2 diabetes, in order to identify those at need of intervention to prevent evolution to clinically relevant hepatic outcomes.
The data from cohort 2 also show that NIS4 significantly outperformed existing non-invasive diagnostic tests in accurately identifying NASH (NAS>4) and significant fibrosis (F>2) in patients with type 2 diabetes. Specifically, NIS4 had an area under receiver operating characteristic (AUROC) performance of 0.801 [0.748; 0.854] (p<0.01) that is statistically superior compared to FIB41 (0.704 [0.641; 0.767]), NFS2 (0.597; [0.527; 0.667]), ELF3 (0.704. [0.642; 0.766]) and Fibrometer (0.678, [0.613; 0.743]). Therefore, NIS4 can demonstrate good diagnostic performance and accurately identify NASH (NAS>4) and significant fibrosis (F>2) in patients with type 2 diabetes.
“These results reiterate the potential superiority of NIS4, our in-house developed four biomarker panel, to statistically identify NASH and fibrosis with superior sensitivity and specificity also observed in patients with type 2 diabetes,” said Suneil Hosmane, Ph.D., Head of Global Diagnostics at GENFIT. “Our ongoing research in this area underscores our commitment to improving diagnosis and treatment experiences for patients with NASH, a potentially life-threatening disease that is on the rise, yet significantly underdiagnosed.”
“The findings presented today are great news for researchers, clinicians and people who are at-risk for NASH. This simple blood test will be instrumental in the NASH patient journey and provide physicians with the tool to identify patients in need of therapeutic intervention,” said Stephen Harrison, study author and Medical Director of Pinnacle Clinical Research. “While liver biopsy is the current clinical reference standard for diagnosis, it is a costly, invasive procedure that can cause pain and discomfort for patients, and can even have serious, life-threatening complications. Currently there are no minimally-invasive tests approved specifically for NASH, which is expected to soon be the primary cause of liver transplant.”
ABOUT NIS4
GENFIT is developing an in vitro diagnostic (IVD) test to identify patients with NASH and fibrosis (F>2, NAS>4), who are the focus of current NASH clinical trials. The NIS4 program is based on the in-house discovery of a 4-biomarker algorithm and is currently pursuing commercialization of this test which aims to be a validated alternative to the liver biopsy. In January, 2019, GENFIT signed a licensing agreement with LabCorp® to roll out the diagnostic kit in the clinical research field, and plans to file NIS4 for formal marketing approval with the FDA in 2020.