21-6-2014
The current study GFT505 ends with the last medical examination of the last patient on November 20th, 2014. Considering the constraints of the end of year, the top – line results will be published near in the middle of January
Mister Mouney announced that Genfit would have all the results of the phase 2b as well as of the follow-up of around thirty biomarkers (persons suffering from a liver complaint, triglycerides, glucose, insulin, safety) fine T1 2015, AND that results will be published during the EASL of April, 2015.
They validated also already with the organization of the EASL the presentation of the action of the GFT505 on the model of the university of Louvain that is the one who imitates completely the natural development of the disease with a specific diet : development insulino-resistance, evolution of the hepatic markers, NASH, fibrosis. After 12 weeks of treatment, put back total NASH and FIBROSIS
Gft505 is the only molecule PPAR two-tier a/d to the world. Generally problems of safety on the PPAR gamma.
The targets of 505 are NASH, diseases CV and fibroses and not metabolic Cirrhosises
More than 600 patients were handled by the GFT505 without this day of major problem of safety. The big advantage of the molecule is that it hépato – centered thus that it does not go to the other organs.
The results are very satisfactory according to the previous studies (increase HDL from 7 to 10 %, decrease LDL of 10 %, decrease of the 30 % triglycerides), while for the OCA breaking news evoke an increase of LDL of 20 %.
Jean-François Mouney reminds however that he does not wish that the product of Intercept is not effective but also confided that the recent explanations of the analysts to try to justify a positive complementary effect which would come counterbalanced in the time the negative effects is not even understood by the best specialists! Especially as he reminded that Genfit worked 6 years ago on the mechanism and the receiver aimed by the OCA thus that they know well the subject.
Genfit is approached by about ten companies specialized in biomarkers because the essay of 505 is the only essay in the world allowing to correlate biopsies to statistics and theoretical approaches.
After the encouraging essays of the GFT505, Genfit decided to apply the molecule to 1 then 2 then 3 models of chronic intestinal diseases. The results were beyond the expectations of the specialists which had rarely seen effects so good.