? Elafibranor is unique and represents a new pharmacological class (first-in-class)
Lille (France), Boston (Massachusetts, United States), June 2nd, 2015 – GENFIT (Euronext: GNFT; ISIN: FR0004163111), a biopharmaceutical company at the forefront of developing therapeutic and diagnostic solutions in metabolic and inflammatory diseases, that notably affect the liver or the gastrointestinal system, today announces that the World Health Organization (WHO) has accepted the international non-proprietary name (INN, or generic name) Elafibranor for its leading drug candidate previously referred to as GFT505.
The aim of the INN system is to provide health professionals with a unique and universal designated name for each pharmaceutical substance. This is important for the clear identification, safe prescription and dispensing of medicines to patients. In the INN system, the names of pharmacologically-related substances have a common "stem", enabling health professionals to recognize substances having similar pharmacological activity.
The new non-proprietary name, Elafibranor, reflects the first-in-class nature of the drug candidate, since it does not contain a pre-existing INN stem. The novel pre-stem "-fibranor" may thus become an established stem over time, as other later developed drugs are recognized to be related in structure or activity.
Jean-François MOUNEY, Chairman & Chief Executive Officer of GENFIT, declared: ”We are very pleased that the INN division of WHO recognized the unique nature of Elafibranor/GFT505 by accepting the proposed generic name for our leading drug candidate. Moreover, their acceptance of the novel pre-stem "-fibranor" reflects the innovative nature of the drug candidate, and marks a new step in our overall development strategy in the run-up to the market launch of this first-in-class product.”
About Elafibranor/GFT505:
Elafibranor is being developed for the treatment of NASH, and has recently completed a major international Phase 2b study in 274 NASH patients in Europe and the United States. Elafibranor showed significant activity on both NASH regression and liver fibrosis scores, as well as a significant improvement in cardiometabolic risk factors and an excellent safety profile. Elafibranor is expected to enter Phase 3 clinical trials in NASH at the end of the year.
About GENFIT:
GENFIT is a biopharmaceutical company focused on the Discovery and Development of drug candidates in fields of high medical need due to a lack of suitable treatment and an increasing number of patients worldwide. GENFIT’s R&D efforts are focused on contributing to bringing new medicines to market for patients with metabolic, inflammatory, autoimmune and fibrotic diseases, that affect the liver (such as NASH - Nonalcoholic steatohepatitis) or the bowel (such as the inflammatory bowel disease). GENFIT implements mutually beneficial approaches that combine novel treatments and biomarkers; its research programs have resulted in the creation of a rich and diversified pipeline of drug candidates, including GENFIT’s lead proprietary compound, GFT505/Elafibranor, that has completed a positive Phase 2b study in NASH and is currently launching a Phase 3 study.
With facilities in Lille, France, and Boston, MA (USA), the Company has approximately 90 employees. GENFIT is a public company listed in compartment B of Euronext’s regulated market in Paris (Euronext: GNFT; ISIN: FR0004163111). www.genfit.com
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Lille (France), Boston (Massachusetts, United States), June 2nd, 2015 – GENFIT (Euronext: GNFT; ISIN: FR0004163111), a biopharmaceutical company at the forefront of developing therapeutic and diagnostic solutions in metabolic and inflammatory diseases, that notably affect the liver or the gastrointestinal system, today announces that the World Health Organization (WHO) has accepted the international non-proprietary name (INN, or generic name) Elafibranor for its leading drug candidate previously referred to as GFT505.
The aim of the INN system is to provide health professionals with a unique and universal designated name for each pharmaceutical substance. This is important for the clear identification, safe prescription and dispensing of medicines to patients. In the INN system, the names of pharmacologically-related substances have a common "stem", enabling health professionals to recognize substances having similar pharmacological activity.
The new non-proprietary name, Elafibranor, reflects the first-in-class nature of the drug candidate, since it does not contain a pre-existing INN stem. The novel pre-stem "-fibranor" may thus become an established stem over time, as other later developed drugs are recognized to be related in structure or activity.
Jean-François MOUNEY, Chairman & Chief Executive Officer of GENFIT, declared: ”We are very pleased that the INN division of WHO recognized the unique nature of Elafibranor/GFT505 by accepting the proposed generic name for our leading drug candidate. Moreover, their acceptance of the novel pre-stem "-fibranor" reflects the innovative nature of the drug candidate, and marks a new step in our overall development strategy in the run-up to the market launch of this first-in-class product.”
About Elafibranor/GFT505:
Elafibranor is being developed for the treatment of NASH, and has recently completed a major international Phase 2b study in 274 NASH patients in Europe and the United States. Elafibranor showed significant activity on both NASH regression and liver fibrosis scores, as well as a significant improvement in cardiometabolic risk factors and an excellent safety profile. Elafibranor is expected to enter Phase 3 clinical trials in NASH at the end of the year.
About GENFIT:
GENFIT is a biopharmaceutical company focused on the Discovery and Development of drug candidates in fields of high medical need due to a lack of suitable treatment and an increasing number of patients worldwide. GENFIT’s R&D efforts are focused on contributing to bringing new medicines to market for patients with metabolic, inflammatory, autoimmune and fibrotic diseases, that affect the liver (such as NASH - Nonalcoholic steatohepatitis) or the bowel (such as the inflammatory bowel disease). GENFIT implements mutually beneficial approaches that combine novel treatments and biomarkers; its research programs have resulted in the creation of a rich and diversified pipeline of drug candidates, including GENFIT’s lead proprietary compound, GFT505/Elafibranor, that has completed a positive Phase 2b study in NASH and is currently launching a Phase 3 study.
With facilities in Lille, France, and Boston, MA (USA), the Company has approximately 90 employees. GENFIT is a public company listed in compartment B of Euronext’s regulated market in Paris (Euronext: GNFT; ISIN: FR0004163111). www.genfit.com
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