Bio Screening Industry News

Phase I results revealed very good tolerance in healthy volunteers as well as an
excellent security profile for GFT14, one of the medical candidates that GENFIT is
developing to tackle cardiometabolic risk.
Lille (France), Cambridge (Massachusetts), 2nd May 2006 – GENFIT, the
biopharmaceutical company engaged in the discovery and development of medical
candidates in the areas of cardiovascular, inflammatory and metabolic diseases, today
announced the entry into Phase II clinical trials of GFT14, destined for the treatment of
cardiometabolic risk.
The decision to commence Phase II was taken in light of the excellent results obtained
during the Phase I. Initiated in March 2005, this test was carried out on over one hundred
healthy volunteers who ingested GFT14 either in a single dose (50 – 500mg) or in a repeated
dose over fourteen days (50 – 300 mg/day).
The results demonstrated that GFT14 attained all of its principal objectives; namely, that no
significant adverse effect was registered during the course of the trials; that any reported
adverse effect was weak, (and without the implication of the treatment being proven); that
GFT14 is very well absorbed with pharmacokinetic parameters being perfectly compatible
with a single daily dose. The trials in a healthy volunteer therefore concluded that GFT14 is
very well tolerated.
“This first phase of clinical trials proved that the innovative formulation of GFT14 developed
by GENFIT produced a very good margin of security”, commented Professeur Fruchart, who
continued : “ Fresh from these promising results, an initial Phase II study targeting the
effectiveness of GFT14 in patients with dyslipidemia has just been undertaken. The first
patient should begin tests later this month, with results expected at the beginning of 2007” .
GFT14, a proprietary compound from GENFIT, is destined to improve the condition of
patients at risk from cardiovascular disease by a simultaneous and favorable action on the
plasmatic lipids (rise of HDL- cholesterol et lowering of triglycerides) and on other risk factors
such as hypertension or diabetes. Orally absorbed GFT14 has absolutely no structural link
with current treatments for dyslipidemia (statin or fibrate based). The risks of medical
interaction are weak and GFT14 may be easily combined with statins or other antidiabetic
molecules (glitazones).
Dyslipidemic patients are defined as having a high level of “bad” cholesterol (LDL-C) and/or
triglycerides and/or a low level of good cholesterol (HDL-C). They have, therefore, an
increased risk of developing atherosclerosis, the clinical complications of which pose serious
health problems, especially in cases of coronary implication.
Jean-François MOUNEY, Chairman and CEO of GENFIT declared:
“ These highly promising results confirm the hypothesis that GFT14 constitutes, thanks to its
novel pharmacological approach, a significant advance in the treatment of metabolic
disorders. The results announced today illustrate our capacity to deliver innovative
therapeutic solutions with huge potential and further reinforce the value of our product
portfolio, currently comprising seventeen research programmes of which nine molecules are
in development. Genfit is engaged in challenging the soaring global cardiometabolic
pandemic characterized by obesity, diabetes and cardiovascular illness which are affecting
an increasingly younger population.”
About GENFIT
The emerging biopharmaceutical company, GENFIT (www.genfit.com) studies gene deregulation,
which is at the origin of some of the most wide-spread diseases. The GENFIT group identifies new
therapeutic targets and develops drug candidates. Its most advanced programs, conducted internally
or in partnership with industry leaders such as SANOFI - AVENTIS, PIERRE FABRE, SOLVAY -
FOURNIER, MERCK AG, UCB, KOWA, SERVIER, concentrate on the treatment of key metabolic and
inflammatory disorders. GENFIT’s initial proprietary medicines will concentrate on global
cardiovascular risk by treating several pathologies, such as atherosclerosis, diabetes and obesity,
simultaneously with a single molecule. Founded and managed by Professeur Jean-Charles
FRUCHART and Mr. Jean-François MOUNEY, the company is headquartered in Lille with facilities in
Cambridge (USA). The company currently employs over 110 people.
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Contacts
GENFIT :
Jean-François MOUNEY, Chairman and CEO
Kate PORTER, Corporate Communications Manager
Phone : +33 (0) 3 20 16 40 11
Phone : +33 (0) 3 20 16 40 79
MILESTONES – Press Relations
Bruno ARABIAN
Phone : +33 (0) 1 70 08 04 13
+33 (0) 6 87 88 47 26