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Non-invasive options for NASH
LILLE, France, CAMBRIDGE, Mass. & BURLINGTON, N.C.—With the new year came the start of a new partnership, as GENFIT and LabCorp opened 2019 by inking a licensing agreement between GENFIT and Covance, LabCorp’s drug development business, to expand access to a liver diagnostic test for non-alcoholic steatohepatitis (NASH).
Under the terms of the licensing agreement, GENFIT’s NIS4 biomarker test will be deployed within the clinic via Covance’s central libraries for further validation and to provide additional insight into NASH pathogenesis. Financial details were not disclosed.
NIS4 is a multiparametric blood-based biomarker test. GENFIT developed the test from a biobank of samples taken from approximately 700 well-characterized patients to determine a combination of biomarkers for the identification and monitoring of patients with NASH and significant liver fibrosis. A key factor of NIS4’s potential is the fact that it is a non-invasive diagnostic option. At present, liver biopsy is the standard for determining a formal NASH diagnosis, which is both invasive and painful for patients.
Jean-François Mouney, chairman and CEO of GENFIT, commented: “We are very enthusiastic to announce this agreement, which represents a major step in GENFIT’s commercial strategy in NASH. The expertise that LabCorp and Covance have in this field will add tremendous value to GENFIT’s pioneering work in developing this innovative technology. I’m excited to see collaborations like this, which will help move the test toward the goal of being an in-vitro diagnostic to identify NASH patients who should be considered for therapeutic intervention.”
As described on GENFIT’s website, NASH “is a liver disease characterized by an accumulation of fat (lipid droplets), along with inflammation and degeneration of hepatocytes. Once installed, the disease is accompanied with a high risk of cirrhosis, a state where the liver functions are altered and can progress to liver insufficiency. Thereafter, the NASH often progresses to liver cancer.” Current estimates are that more than 12 percent of U.S. adults have NASH, GENFIT notes, and within diabetics that increases to 22 percent. Approximately 15 to 25 percent of patients with NASH will develop cirrhosis.
“LabCorp and Covance will be able to leverage our experience in clinical trial biomarkers and diagnostics development to validate the NIS4 algorithm,” added Dr. Marcia Eisenberg, chief scientific officer for LabCorp Diagnostics. “We are well positioned to expand access to NIS4 to the global clinical research community through this agreement. Forward-thinking collaborations like this one enable early and efficient validation of diagnostics that have the potential to significantly impact patients with serious, life-changing unmet medical needs, including NASH.”
On the treatment side, GENFIT is also advancing GFT505, Elafibranor, as an orally administered therapy for NASH. In a Phase 1 program, Elafibranor showed a positive safety profile in overweight/obese patients as well as those with type 2 diabetes, and was not found to demonstrate any drug-drug interaction with sitagliptin, simvastatin or warfarin. In a Phase 2 program evaluating the compound’s safety and efficacy in patients with cardiometabolic disorders, Elafibranor reduced inflammation markers and markers of liver injury, and GENFIT noted that “An activity profile beneficial for NASH patients has been consistently found in all the trials.” The compound is now being evaluated in a Phase 3 study titled RESOLVE-IT.
In other partnering news for LabCorp, the company announced another agreement soon after sharing news of its deal with GENFIT. Under a new agreement with the Texas Association of Community Health Centers Inc. (TACHC), a private non-profit association of roughly 75 community health centers in Texas, LabCorp will serve as the TACHC’s exclusive preferred laboratory. The two organizations will apply data analytics to identify population health trends to boost outreach regarding screening and treatment options for common health issues. In addition, TACHC plans to offer LabCorp’s Litholink clinical decision support programs to its members, with targeted guidance regarding tests, treatments and lifestyle options.
“For many years, our member health centers have depended on LabCorp to provide high-quality testing services for the patients they serve, and we are pleased to extend our relationship with LabCorp,” remarked José E. Camacho, Esq., executive director and general counsel for TACHC. “We look forward to enhancing the scope of laboratory services that will be available to our clinicians, which will provide immediate and long-term benefits for the patients we serve every day. In particular, we expect that the use of data analytics will help us better address health trends across the populations we serve, and that new programs for chronic diseases will have a positive impact on the lives and health of our patients.”