Lille (France), Cambridge (Massachusetts, United States), August 05, 2020 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and chronic liver diseases, today announced that pivotal data describing the derivation and validation of NIS4™ has been accepted for publication by The Lancet Gastroenterology & Hepatology. NIS4™ is GENFIT’s novel non-invasive, blood-based diagnostic technology, developed to identify patients with non-alcoholic steatohepatitis (NASH) and significant to advanced fibrosis (F>2), also referred to as at-risk NASH in the published study.
Suneil Hosmane, PhD, Head of Global Diagnostics at GENFIT commented: “This publication represents a milestone achievement for our NIS4™ technology. The data presented in The Lancet Gastroenterology and Hepatology showcases not only the robust and consistent performance of NIS4™ to identify at-risk NASH, but also the improved performance of NIS4™ relative to other technologies including commonly used liver fibrosis tests. We believe blood-based diagnostic tests powered by NIS4™ technology will play a critical role in the diagnosis and management of patients with NASH. The majority of patients with at-risk NASH, who are at higher risk of progression to severe liver complications, have not been diagnosed and a non-invasive approach to identify them is paramount. The complexity of underlying chronic liver diseases, such as NASH, is that these conditions often do not present with obvious symptoms until the disease is in very advanced stages. Hence, we believe non-invasive testing will continue to gain importance within healthcare systems given the capability to identify those who may require more aggressive medical intervention with a simple blood draw while maintaining high diagnostic accuracy.”
The NIS4™ technology is an algorithm that incorporates four independent NASH-associated biomarkers – miR-34a-5p, A2M, YKL-40, and HbA1c – to produce a score that can be utilized to identify patients with or without at-risk NASH. This published study details NIS4™ algorithm development and clinical validation against the liver biopsy reference standard in two independent populations comprised of data from over 700 patients. Apart from high overall diagnostic performance, NIS4™ also provided consistent results in critical sub-populations (i.e. diabetic vs. non-diabetic, men vs. women) as compared to other non-invasive tests evaluated in the same individuals.
Prof. Arun Sanyal, MD, Department of Internal Medicine, Virginia Commonwealth University School of Medicine in Richmond, VA, USA, noted: “There is a major unmet need to establish simple tools that can be used in all patients with risk factors to identify those with non-alcoholic steatohepatitis with enough disease activity and fibrosis to be considered for more intense therapies over and above lifestyle changes. The current study is a key step in meeting this unmet need and demonstrates that the NIS4 score can be used to enrich the likelihood of identifying this subpopulation amongst those who are overweight or are obese with or without diabetes. This paves the way for development of patient identification and treatment paradigms that are non-invasive and available to all clinics.”
GENFIT intends to license NIS4™ technology to a major diagnostic partner to enable the development and projected launch of a clinical diagnostic test powered by NIS4™ in the second half of 2020. GENFIT also continues to explore opportunities to obtain formal marketing authorization of an in vitro diagnostic (IVD) version of NIS4™ in both the U.S. and European markets.
NIS4™ is GENFIT’s non-invasive, blood-based diagnostic technology, which was developed to identify patients with non-alcoholic steatohepatitis (NASH) and significant to advanced fibrosis (F>2), also referred to as at-risk NASH. In January 2019, GENFIT signed a licensing agreement with LabCorp® to make NIS4™ technology available for use in clinical research through their drug development subsidiary, Covance. GENFIT also continues to explore opportunities to obtain formal marketing authorization of an in vitro diagnostic (IVD) version of NIS4™ in both the U.S. and European markets. For more information, please visit: https://nis4.com
GENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and liver diseases. GENFIT is a pioneer in the field of nuclear receptor-based drug discovery, with a rich history and strong scientific heritage spanning more than two decades. GENFIT plans to initiate a Phase 3 clinical trial of elafibranor in patients with PBC. As part of GENFIT’s comprehensive approach to clinical management of patients with liver disease, the Company is also developing NIS4™, a new, non-invasive blood-based diagnostic technology which, if approved, could enable easier identification of patients with at-risk NASH. With facilities in Lille and Paris, France, and Cambridge, MA, USA, the Company has approximately 200 employees. GENFIT is a publicly traded company listed on the Nasdaq Global Select Market and on compartment B of Euronext’s regulated market in Paris (Nasdaq and Euronext: GNFT). www.genfit.com