Lille (France), Boston (Massachusetts, United States), October 25, 2013 – GENFIT (Alternext: ALGFT; ISIN: FR0004163111), a biopharmaceutical company at the forefront of drug discovery and development, focusing on the early diagnosis and preventive treatment of cardiometabolic and associated disorders, today announces the recommendation of the independent Data Safety and Monitoring Board (DSMB) of international experts charged with ensuring the safety of use of GFT505 in the current Phase IIb study. The DSMB gives its unrestricted approval to continue the Phase IIb clinical trial in NASH according to the planned protocol.
GENFIT launched the Phase IIb study of GFT505 in NASH in September 2012, after obtaining FDA (Food and Drug Administration) approval to perform the study in the United States. To date the study has recruited 139 diabetic and non-diabetic patients with a histological diagnosis of NASH by liver biopsy at the time of recruitment. The study is currently ongoing in Europe and the United States in 56 clinical investigation centers.
The members of the DSMB, an independent committee set up to ensure patient safety within the Phase IIb study, analyzed the complete safety data for patients that have been treated for more than 6 months with GFT505 at 80 mg/day. The members of the DSMB unanimously concluded that, after more than 6 months of treatment at the dose of 80 mg/day, GFT505 shows no safety issue that compromises the continuation of the Phase IIb study. Jean-François MOUNEY, Chairman and Chief Executive Officer of GENFIT, declared: « We are extremely pleased with this decision that marks a much-awaited key step in this study, and further adds to the potential value of our drug candidate. Indeed the DSMB has given its unrestricted approval to move to the higher dose of GFT505, and recommends the continuation of the study according to the planned protocol. Consequently, the next patients that are randomized to receive GFT505 in the trial will be treated at 120 mg/day for 12 months.
About GENFIT:
GENFIT is a biopharmaceutical company focused on the Discovery and Development of drug candidates in therapeutic fields linked to cardiometabolic disorders (prediabetes/diabetes, atherosclerosis, dyslipidemia, inflammatory diseases…). GENFIT uses a multi-pronged approach based on early diagnosis, preventive solutions, and therapeutic treatments and advances therapeutic research programs, either independently or in partnership with leading pharmaceutical companies, including Sanofi, to address these major public health concerns and their unmet medical needs.
GENFIT’s research programs have resulted in the creation of a rich and diversified pipeline of drug candidates at different stages of development, including GENFIT’s lead proprietary compound, GFT505, that is currently in Phase IIb.
With facilities in Lille, France, and Cambridge, MA (USA), the Company has approximately 80 employees. GENFIT is a public company listed on the Alternext trading market by Euronext™ Paris (Alternext: ALGFT; ISIN: FR0004163111). www.genfit.com
Contacts:
GENFIT Jean-François Mouney – CEO & Chairman of the Management Board Ph. +333 2016 4000
MILESTONES – Press Relations Bruno Arabian Ph. +331 7544 8740 / +336 8788 4726 – barabian@milestones.fr
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