GENFIT: Promising GFT505 results in Phase II
GENFIT announced positive results in Phase II with its most advanced drug candidate, GFT505, in prediabetic patients with atherogenic dyslipidemia and abdominal obesity (study GFT505-2083).
Analysis of the results of this clinical trial showed that GFT505 was very well tolerated at the dose of 80mg/day and presented a very good safety of use. No specific adverse event was observed in the GFT505 treated group relative to the placebo treated group.
All primary objectives of the study were reached. Relative to the placebo group, therapeutic efficacy of GFT505 was demonstrated with a statistically significant 21% (p=0.0027) reduction of plasma triglycerides and a 9% (p=0.003) increase in good cholesterol (HDL-C) level. These metabolic effects were comparable to those published with the best competitors (fibrates) in the same patient population.
Furthermore, GFT505 revealed a remarkable 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).
Finally, GFT505 showed significant effects on multiple secondary evaluation criteria related to lipid metabolism and inflammation. Notably, GFT505 significantly reduced acute phase inflammation markers such as fibrinogen (p=0.045) and haptoglobin (p=0.009).
Pr. Bart Staels, Chairman of the Scientific Advisory Board, stated: "All the data clearly argue in favor of increased therapeutic potential and safety of GFT505 relative to existing treatments. Of course, all these beneficial effects should be confirmed in additional clinical trials but they already position GFT505 as the first drug candidate of a new therapeutic class selectively and simultaneously acting on two distinct nuclear receptors."
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