Genfit Reports Positive Results In Phase II Trial For GFT505

Published: 26-Nov-2009

GFT505 was well tolerated and presented a good safety of use

Genfit has reported positive results in Phase II trial with its most advanced drug candidate, GFT505, in prediabetic patients with atherogenic dyslipidemia and abdominal obesity (study GFT505-2083).

The results of the clinical trial showed that GFT505 was well tolerated at the dose of 80mg/day and presented a good safety of use. No specific adverse event was observed in the GFT505 treated group relative to the placebo treated group.

In the study, all primary objectives were reached, claims the company. Relative to the placebo group, therapeutic efficacy of GFT505 was demonstrated with a statistically 21% reduction of plasma triglycerides and a 9% increase in good cholesterol (HDL-C) level.

In addition, GFT505 has revealed a lack of effect on a known cardiovasuclar risk factor, homocysteine (5% vs 40 to 50% reported with fenofibrate) and on a marker of renal dysfunction, creatinine (non significant vs 10 to 15% reported with fenofibrate). It also showed positive effects on multiple secondary evaluation criteria related to lipid metabolism and inflammation, and reduced acute phase inflammation markers such as fibrinogen and haptoglobin.

Jean-François Mouney, CEO of Genfit, said: "We are highly satisfied with these results which fulfill all our expectations. The safety of use as well as efficacy results on the primary end points of the study confirm that GFT505 has the potential of becoming a top drug for the medical care of various patient populations in prediabetic states.

“About 50% of these patients will evolve towards overt type II diabetes over five years. Thus, with the data already obtained, we are very confident in our capacity to find an industrial partner to pursue the clinical development of GFT505 and ensure its commercialisation. We are in close discussions with three international pharmaceutical groups and are initiating a due diligence with one of them."

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