Genfit: Extremely Promising Gft505 Results In Phase Ii
? THE DRUG CANDIDATE GFT505 STATISTICALLY MEETS ALL THE
PRIMARY END POINTS OF THE STUDY GFT505-2083 IN PREDIABETIC
PATIENTS
? THE STUDY CONFIRMS THE EXCELLENT EFFICACY TO SAFETY RATIO OF
GFT505 IN PATIENTS SUFFERING FROM ATHEROGENIC DYSLIPIDEMIA
? SECONDARY EVALUATION CRITERIA REVEAL ADDITIONAL EFFECTS
WHICH CAN EXTEND THE THERAPEUTIC POSITIONING OF GFT505
? GENFIT IS IN DISCUSSIONS WITH THREE INTERNATIONAL
PHARMACEUTICAL GROUPS TO ENSURE THE FOLLOW ON DEVELOPMENT OF
GFT505
?
Lille (France), Cambridge (Massachusetts, United States), November
23, 2009 – 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
announced extremely 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."
Jean-François Mouney, CEO of GENFIT concluded: "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, a disorder which current treatments -most of which are blockbusters- fail to block. 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 commercialization. We are in close discussions with three international pharmaceutical groups and are initiating a due diligence with one of them."
About the phase II clinical trial (GFT505-2083):
This phase II clinical trial included 97 patients suffering from
atherogenic dyslipidemia (plasma triglycerides >150mg/dL and
HDL-Cholesterol <40 mg>102cm for men and
>88 cm for women). This was a double blind, randomized, placebo
controlled study for assessing the safety and efficacy of 28 days
oral treatment with GFT505 at 80mg/d. Efficacy was assessed by
comparing changes in plasma triglycerides and HDL-C in the GFT505
treated group (n=63) vs the placebo treated group (n=31).
About treatment of prediabetes, diabetes:
The worldwide epidemic of obesity forecasts a parallel increase in
the prevalence of type II diabetes and associated complications.
According to the WHO, this “epidemic disease” could
affect up to 300 million people by 2025 whereas they were only 30
million in 1985. Thus, the prevention and treatment of micro and
macro-vascular diseases associated with prediabetes and diabetes
are considered as worldwide public health issues by both academic
societies (IAS, ADA, EASD) and health organizations (WHO, FDA,
EMEA). The prediabetic and diabetic patients suffer from
overlapping disorders (high blood pressure, dyslipidemia, insulin
resistance, inflammation...) which increase the risk of developing
type II diabetes as well as related micro and macro-vascular
diseases: myocardial infarction, stroke, retinopathy, kidney
disease, diabetic foot or arteritis… The weaknesses of
diagnosis tools and current treatments do not totally cover this
global medical need. At present, even treated patients remain
at high risk of developing vascular diseases. In particular,
atherogenic dyslipidemia (characterized by low plasma concentration
of good cholesterol (HDL-C) and high level of triglycerides), the
pro-inflammatory and oxidative states and alteration of glucose
metabolism are promising therapeutic targets for the medical
management of prediabetic and diabetic populations.
About GENFIT:
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…). GENFIT uses a multi-pronged
approach based on early diagnosis, preventive solutions, and
therapeutic treatments to address these major public health
concerns and their unmet medical needs. GENFIT’s
proprietary research programs and its partnerships with leading
pharmaceutical companies, including SANOFI-AVENTIS, SOLVAY GROUP,
and SERVIER, have resulted in the creation of a rich and
diversified pipeline of drug candidates at different stages of
development. GENFIT’s lead proprietary compound, GFT505, is
currently in Phase II and two other compounds, in partnership with
SANOFI-AVENTIS (AVE0897) and SOLVAY (SLV341), are in the advanced
stages of Phase I.
With facilities in Lille, France, and Cambridge, MA (USA), the
Company has about 130 employees, including over 100 scientists.
GENFIT is a public company listed on the Alternext trading market
by Euronext™ Paris (Alternext: ALGFT; ISIN: FR0004163111).
www.genfit.com
Contacts:
GENFIT
Jean-François Mouney – Chairman of the Management
Board
+33 (0)3 20 16 40 00
MILESTONES – Press Relations
Bruno Arabian
+33 (0)1 75 44 87 40 / +33 (0)6 87 88 47 26 – barabian@milestones.fr
Posted: November 2009
