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GENFIT's GFT505 exhibits potential to address unmet needs in prediabetic and diabetic patients

Published on January 28, 2010 at 3:59 AM · No Comments

NEW CLINICAL EFFICACY RESULTS DEMONSTRATE THAT GFT505:

  • REDUCES GLOBAL CARDIOVASCULAR RISK FACTORS IN PREDIABETIC PATIENTS WITH IMPAIRED GLUCOSE TOLERANCE
  • DECREASES FASTING GLUCOSE LEVELS AND IMPROVES INSULIN SENSITIVITY
  • HAS A POSITIVE IMPACT ON LIPID PARAMETERS (TRIGLYCERIDES AND CHOLESTEROL)
  • HAS ANTI-INFLAMMATORY EFFECTS

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 neurodegenerative diseases, today announces positive results from a recently completed clinical trial demonstrating the activity of GFT505 on glucose homeostasis. Results from the clinical trial (GFT505-2094) clearly demonstrate the potential of the drug candidate to reduce global cardiovascular risk in prediabetic patients who suffer from impaired fasting plasma glucose, impaired glucose tolerance, and abdominal obesity.

Following treatment with GFT505 (80mg/day) for 28-days, the main objective of the study which was demonstration of efficacy of the compound on glucose homeostasis was attained. GFT505 led to a significant reduction in fasting plasma glucose levels in the treated group in comparison to the placebo treated group (-5% vs placebo,>

In addition to the effects of GFT505 on glucose homeostasis and parallel to results from the previous study (GFT505-2083), the new results from the GFT505-2094 study clearly reaffirm the beneficial effects of the compound on plasma lipids and demonstrate an additional effect on LDL-C. Patients treated with GFT505 had a significant reduction of bad cholesterol (LDL-C, -11% vs placebo,>

Taken together, the effects of GFT505 on plasma glucose, lipids, and inflammation, are expected to strongly reduce the risk of macrovascular events and microvascular complications found in prediabetic patients. The present study also confirms the favorable efficacy/safety ratio of GFT505, considering that no specific side effects were observed between the treated and placebo groups. In particular, treatment with GFT505, in contrast to fenofibrate, did not increase the level of circulating homocysteine which is considered a marker of cardiovascular risk.

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