Genfit, a biopharmaceutical company at the forefront of drug discovery and development, focusing on the early diagnosis and preventive treatment of cardiometabolic and neurodegenerative diseases, announced the absence of a safety risk due to pharmacokinetic drug-drug interaction when GFT505 is coadministered with a statin (GFT505-1095 clinical study). These results prepare the launch of phase-IIb and phase-III trials in patients already treated with a statin (on-top of statin trials).
Furthermore, Genfit is now evaluating the opportunity to develop a combination therapy associating GFT505 with a generic statin in the Certain fibrates are associated with an increased risk of serious muscular side-effects when they are coadministered with a statin. Indeed, these drugs significantly increase the plasma concentration of certain statins (including simvastatin) and/or their active metabolites. This pharmacokinetic drug-drug interaction increases the risk of muscular side-effects associated with hypolipidemic agents. To assess the safety of use of GFT505 in co-administration of a therapeutic dose of GFT505 (80 mg/d) with a usual dose of simvastatin (20 mg/d), the study GFT505-1095 was conducted in two parallel groups of healthy
In the first group, a repeated daily administration of GFT505 for 14 days did not increase the plasma exposure of simvastatin and its active metabolite. On the contrary, a modest but statistically significant decrease in this exposure was observed.
In the second group, a repeated daily administration of simvastatin for 14 days did not affect the plasma exposure of GFT505 and its active metabolite GFT1007. No adverse side-effect was observed when either drug was administered for 14 days. As expected, simvastatin treatment resulted in a reduction in the plasma levels of LDL-cholesterol, and GFT505 treatment resulted in a reduction in plasma triglyceride levels. Moreover, no adverse reaction was observed when GFT505 and simvastatin were co-administered at the end of the 14-day treatment periods.
Items in this press release may contain forward-looking statements involving risks and uncertainties. The Company’s actual results could differ substantially from those anticipated in these statements owing to various risk factors which are described in the company’s prospectus.
Dr Rémy Hanf, vice-president of Product Development, stated, "These new data are of vital importance, since GFT505 targets the residual cardiovascular risk that persists in patients treated with statins. These patients make up a substantial proportion of the target pre-diabetic and diabetic population. In sharp contrast to the demonstrated pharmacokinetic interaction of certain fibrates with statins, GFT505 could potentially be prescribed to the entire pre-diabetic and diabetic population, irrespective of whether patients are already under statin treatment or not.”
Jean-François Mouney, CEO of Genfit, added, “We were awaiting the results of this clinical study with impatience, since the information it provides substantially increases the intrinsic value of GFT505. The absence of a pharmacokinetic interaction between GFT505 and statins provides GFT505 with an undeniable competitive advantage that is of critical importance for the pharmaceutical groups with which we are discussing.”
Genfit is a biopharmaceutical company focused on the Discovery and Development of drug candidates in strategic therapeutic fields linked to cardiometabolic and neurodegenerative disorders (prediabetes/diabetes, atherosclerosis, dyslipidemia, obesity, Alzheimer’s).