The data of tolerance and job security, including the side effects, and laboratory data, were reviewed by the Data Safety Monitoring Board (DSMB) an oversight committee and independent monitoring, which has recommended the continuation of the clinical trial without any modification.
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Lille (France), Cambridge (Massachusetts, Usa), 1 June 2017 GENFIT (Euronext: GNFT – ISIN : FR0004163111), a biopharmaceutical company engaged in the discovery and development of therapeutics and diagnostics in the field of metabolic diseases and inflammatory, particularly concerning the sphere of hepato-gastroentérologique, today announced that the Data Safety Monitoring Board (DSMB) an oversight committee and independent monitoring has made a positive recommendation for the continuation of the Phase 3 clinical trial of RESOLVE-IT in the NASH without any modification.
Dean Hum, Chief Scientific Officer of GENFIT, declared : “We are pleased that the committee for monitoring and follow-up has not made any reservation requiring a change of the study. We consider this recommendation as a positive sign for the clinical trial of RESOLVE-IT continues today. The NASH is a chronic condition : the security profile of the employment of any molecule intended to treat this pathology is, therefore, crucial. The positive outcome of this review of safety by the DSMB allows us to continue actively recruiting patients. ”
Elafibranor is the compound the most advanced portfolio of GENFIT. Elafibranor is a molecule of type ” first-in-class Agonist of the Receptor Activated by the Peroxisome Proliferator alpha, delta, administered once per day orally, developed to treat, in particular nonalcoholic steatohepatitis (NASH). Elafibranor is considered to be capable of handling the multiple facets of NASH such as inflammation, insulin sensitivity, profiles, and lipid and metabolic markers in the liver.
ABOUT THE NASH
The ” NASH “, or nonalcoholic steatohepatitis, is a liver disease that combines a accumulation of fat in the liver, inflammation and degeneration of the liver cells. The disease is associated with a high risk of progression to cirrhosis, a state corresponding to a liver function deteriorated, leading to liver failure and liver cancer.
GENFIT is a biopharmaceutical company dedicated to the discovery and development of drugs in therapeutic areas where medical needs are significant due to the lack of effective treatments and because of the increase in the number of patients at the global level. GENFIT focuses its R&D efforts to participate in the placing on the market of therapeutic solutions to combat certain metabolic diseases, inflammatory, autoimmune, or fibrotic affecting in particular the liver (such as non-alcoholic steatohepatitis or NASH), and more generally the gastro-intestinal tract. GENFIT implements approaches that combine novel treatments and biomarkers. Elafibranor, proprietary compound of GENFIT’s most advanced, is in phase 3 clinical trials. Installed in Lille, Paris and Cambridge, MA (USA), the company has approximately 130 employees. GENFIT is a public company listed on the regulated market of Euronext in Paris, Compartment B (Euronext : GNFT – ISIN : FR0004163111).
This press release contains forward-looking statements. Although the Company believes that its expectations are based on reasonable assumptions, these forward-looking statements may be affected by a number of risks and uncertainties, which could give rise to substantially different results from those described in, or implied or projected in such forward-looking statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, including in the field of biomarkers, the progress and results of the clinical trial, RESOLVE-IT, for reviews and authorizations of regulatory authorities such as the FDA and EMA concerning, in particular, Elafibranor in the NASH, PBC and other indications, as well as the biomarkers developed by the Company, the success of a strategy of in-licensing, the Company’s ability to continue to raise funds for its development, as well as those developed in section 4 “Principal Risks and uncertainties” of the Reference Document registered by the Autorité des marchés financiers (AMF) on April 28, 2017 under the number R. 17-034 available on the Internet websites of GENFIT (www.genfit.fr) and of the AMF (www.amf-france.org). Subject to the applicable regulations, the Company undertakes no obligation to update or revise any of the information contained in this press release.
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