Jean-Fran?§ois Mouney, CEO of GENFIT, stated: Together with the results from the GFT505-2083 trial communicated in December 2009, the results of the present study demonstrate the strong potential of GFT505 as a therapy to address the existing unmet needs in prediabetic and diabetic patients. An extremely important point about GFT505 is obtaining the therapeutic effects without any identifiable undesirable side effects. Therefore, we consider the efficacy/safety profile of GFT505 unparalleled in this indication, in comparison to products on the market, as well as, to those under development. Of course, these results reinforce our conviction to be able to partner this program with a major pharmaceutical company to further advance the clinical development into Phase IIb and ultimately completion of Phase III studies and the marketing of GFT505.
Dr. Dean W. Hum, CSO and Dr. R?İmy Hanf, Vice-president of product development at GENFIT, added: The Phase IIa program with the objective to provide proof of efficacy of GFT505 is now complete. The effect of the compound on glucose homeostasis is of course very important considering that it clearly differentiates GFT505 from its competitors. Following our complete analysis of the present study and in combination with the data from previous studies, Genfit will design the pivotal phase IIb study to optimize the future development plan of GFT505. Genfit is assembling a dedicated Steering Committee presided by Professor Bart Staels to oversee the advancement of GFT505. This committee will be composed of experts in the field and is scheduled to meet during the first quarter of 2010. In light of the recent results, several internationally renowned experts have already accepted to participate in this committee and to guide the development of GFT505.
Source GENFIT