GENFIT Announces Compelling Results for NIS2+™ Next-Generation Noninvasive Diagnostic Technology in NASH to be Showcased at AASLD Liver Meeting®
NIS2+™ developed and validated inasmuch as optimization NIS4® technology for the detection of NASH patients at risk
Data demonstrate robust and improved clinical performance of NIS2+™ allowing effective identification of at-risk NASHregardless of patient characteristics such as age, gender and type 2 diabetes
NIS2+™’s analytical improvement To allows for bigr large-scale implementation in clinical practice and clinical trials
three posterss to be presented to the AASLD Meeting of the Liver®
Lille (France)), Cambridge (Massachusetts, USA), October 252022 – GENFIT (Nasdaq and Euronext: GNFT)a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver disease, today announced that it has developed NIS2+™, a next-generation technology for the diagnosis of non-alcoholic steatohepatitis (NASH) in risk, and will present NIS2+™ clinical performance results in three poster presentations at The Liver Meeting® 2022 hosted by the American Association for the Study of Liver Diseases (AASLD).
The first poster promotes NIS2+™ as an optimization of NIS4® technology for identifying at-risk NASH. This next-generation technology addresses unmet needs for identifying at-risk NASH patients using non-invasive tests (NIT) that are unaffected by critical patient characteristics. NIS2+™ demonstrated strong clinical performance in detecting at-risk NASH, while its composite scores were not impacted by the status of important subpopulations such as type 2 diabetes, age, and gender . While NIS4®was convincing, the distributions of the composite scores were significantly affected in certain subpopulations. In addition, the increased robustness and simplicity of the NIS2+™ technology (from a panel of 4 to 2 biomarkers) allows a broader and easier application in the clinical setting.
The second poster demonstrates that NIS2+™ is an effective screening tool for recruiting at-risk NASH patients into clinical trials, reducing liver biopsy failure rates and associated costs without inflating the number of patients to be screened .
Data from the third poster highlights NIS2+™ as a valuable prognostic tool for early detection of fibrosis progression in at-risk NASH patients with significant fibrosis (F2) to advanced fibrosis (F3) and cirrhosis (F4). ).
In November 2021, NIS4® the usefulness of the technology has been validated in a phase 1 study1 undertaken by the Non-Invasive Biomarkers of Metabolic Liver Disease (NIMBLE) initiative of the Foundation for the National Institutes of Health’s Biomarkers Consortium as demonstrating strong and unique performance in identifying at-risk NASH patients.2
Dr. Vlad Ratziu, Professor at Sorbonne University and Pitie-Salpetriere Hospital in Paris, France commented : “Rapid diagnosis of at-risk NASH patients is a critical unmet medical need, and so we welcome this next-generation diagnostic tool. NIS2+™ simplifies the analytical process with only two biomarkers, is more robust in terms of composite scores in critical subpopulations of interest, and can be widely implemented in clinical practice. I anticipate that in clinical practice, NIS2+™ will be a diagnostic test of choice to select NASH patients requiring pharmacotherapy, eliminating the need for a liver biopsy – a real progress for the management of patients. Moreover, there is a need for no–invasive tests for facilitate enrollment in NASH clinical trialsso that the number of liver biopsies, with their many challenges, can be reduced.”
Poster number 1: #2484
Title: Derivation and validation of the NIS2+™ blood biomarker panel, an improvement of NIS4® Technology for identification of NASH at risk
Authors: Harrison SA, Ratziu V et al.
Poster number 2: #2503
Title: NIS2+™ Technology as a Screening Tool for Recruiting At-Risk NASH Patients into Clinical Trials
Authors: Ratziu V et al.
Poster number 3: #2522
Title: NIS2+™, an enhancement of NIS4® Technology for the early detection of fibrosis progression in patients with at-risk NASH proven by liver biopsy and F2
Authors: Ratziu V et al.
ON THE LIVER REUNION®
The meeting of the liver® organized by the AASLD is one of the most important hepatology congresses for the medical and scientific community. It brings together more than 10,000 scientists, gastroenterologists and hepatologists from all over the world. The meeting of the liver® 2022 will be held November 4-8, 2022 at the Walter E. Washington Convention Center in Washington DC.
GENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver disease characterized by significant unmet medical needs. GENFIT is a pioneer in the research and development of therapeutic and diagnostic solutions in liver disease, with a rich history and a strong scientific heritage spanning more than two decades. Thanks to its expertise in bringing high-potential early-stage actives to advanced development and pre-marketing stages, GENFIT now has a growing and diversified pipeline of innovative therapeutic and diagnostic solutions.
Its R&D is centered on three franchises: cholestatic diseases, Acute on Chronic Liver Failure (ACLF) and NASH diagnostics. In its cholestatic disease franchise, ELATIVE™, a global Phase 3 trial evaluating elafibranor3 in patients with primary biliary cholangitis (PBC) is on track after a successful Phase 2 clinical trial. The first data is expected to be announced in the second quarter of 2023. In 2021, GENFIT signed an exclusive license agreement with IPSEN to develop, manufacture and commercialize elafibranor in PBC and other indications.4 GENFIT is also developing GNS5611 in cholangiocarcinoma following the acquisition of exclusive rights in this indication from Genoscience Pharma in 20215. In ACLF, a Phase 1 clinical program with nitazoxanide was initiated in 2021, and GENFIT further expanded its ACLF pipeline in 2022 through the acquisition of Swiss clinical-stage company Versantis, with a Phase-ready program. 2 evaluating liposome technology and a small molecule preclinical study. As part of its diagnostic solutions franchise, the Company entered into an agreement with Labcorp in 2021 to commercialize NASHnext®powered by GENFIT NIS4 proprietary diagnostic technology®and recently developed NIS2+™, a scalable and optimized diagnostic tool to identify at-risk NASH.
GENFIT has facilities in Lille and Paris, France, and in Cambridge, MA, USA. GENFIT is listed on the Nasdaq Global Select Market and on compartment B of the regulated Euronext market in Paris (Nasdaq and Euronext: GNFT). In 2021, IPSEN became one of the first shareholders of GENFIT and holds 8% of the company’s capital. www.genfit.com
NIS2+™ is a blood diagnostic test specially designed to detect at-risk NASH in patients with metabolic risk factors based on an independent panel of 2 biomarkers. It has been developed and validated by GENFIT as a robust NIT on characteristics of interest such as type 2 diabetes, age and sex, allowing large-scale implementation in clinical practice.
This press release contains certain forward-looking statements regarding GENFIT, including those within the meaning of the Private Securities Litigation Reform Act of 1995, relating to the clinical performance of NIS2+™ and its suitability for use as a prognostic assessment of progressive fibrosis. The use of certain words, including “consider”, “contemplate”, “think”, “aim”, “expect”, “understand”, “should”, “aspire”, “estimate”, “believe “, “wish”, “may”, “could”, “allow”, “seek”, “encourage” or “trust” or (as applicable) the negative forms of these terms or any other variations of these terms or other similar terms their meaning is intended to identify forward-looking statements. Although the Company believes that its projections are based on reasonable expectations and assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially. of those expressed, implied or intended by the forward-looking statements. These risks and uncertainties include, among others, uncertainties inherent in research and development, including with respect to safety, biomarkers, the progress and results of its ongoing and planned clinical trials, the review and approval by regulatory authorities of its drugs and diagnostic candidates, the impact of the COVID-19 pandemic, fluctuations in exchange rates and the Company’s continued ability to raise capital to finance its development, as well as the risks and uncertainties discussed or identified in the public documents filed by the Company with the AMF, including those listed in Chapter 2 “Principal risks and uncertainties” of the Company’s 2021 Universal Registration Document filed with the AMF on April 29, 2022 under number D.22-0400, available on the Company’s website (www.genfit.com) and on the AMF’s website (www.amf-france.org) and the documents and pub reports lics filed with the United States Securities and Exchange Commission (“SEC”), including the Company’s 2021 Annual Report on Form 20-F filed with the SEC on April 29, 2022 and the 2022 Half-Year Business and Financial Report Furthermore, even if the results, performance, financial condition and liquidity of the Company, and the development of the industry in which it operates are consistent with these forward-looking statements, they may not be predictive of the results or developments. in future periods. These forward-looking statements speak only as of the date of the publication of this document. Except as required by applicable law, the Company undertakes no obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.
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3 Elafibranor and GNS561 are investigational compounds that have not been reviewed or approved by any regulatory authority
4 With the exception of China, Hong Kong, Taiwan and Macao where Terns Pharmaceuticals holds the exclusive license to develop and commercialize elafibranor
5 The agreement includes marketing and development in the United States, Canada and Europe, including the United Kingdom and Switzerland