GENFIT ANNOUNCES TOPLINE RESULTS §§
R4inb0w 17:51 - 26.03.2015? 0
GENFIT: GENFIT ANNOUNCES TOPLINE RESULTS FROM THE GOLDEN-505 TRIAL IN NASH
2015-03-26 16:49:14.912 GMT
GENFIT ANNOUNCES TOPLINE RESULTS FROM THE GOLDEN-505 TRIAL IN NASH
* GFT505 demonstrates DOSE-DEPENDENT efficacy on the primary endpoint, AFTER
CONTROLLING FOR BASElINE SEVERITY AND HETEROGENEITY (P=0.027)
* Treatment with GFT505 leads to significant cardio-metabolic benefits
* GFT505 was safe and well tolerated in this 1-year trial
Lille (France), Boston (Massachusetts, United States),March 26, 2015 - GENFIT
(Euronext: GNFT; ISIN: FR0004163111), today announces topline results of the
phase 2 GOLDEN-505 trial i
NASH.
Due to the unexpected rate of resolution of NASH in patients randomized to
placebo who had early NASH (NAS of 3, placebo response rate>57%), along with
the high number of sites for a limited sample size, the study as initially
designed did not enable the trial to meet directly the primary endpoint. With
correction for this baseline severity and site heterogeneity by a standardized
statistical analysis, GFT505 120mg meets the primary endpoint: Reversal on
NASH without worsening of fibrosis, as detailed below.
Treatment with GFT505 provides a significant beneficial effect on the primary
endpoint (GFT505 120mg vs placebo, p=0.016, RR=2.03) in the global randomized
population (n=274, full analysis set), where patients without an end of
treatment biopsy were considered as non-responders. The primary endpoint was
also achieved in the evaluable population of patients who underwent both
baseline and end of study liver biopsies (n=237, ITT; p=0.027 vs placebo;
RR=1.94). In the evaluable patient population, GFT505 120mg also has a
beneficial effect of a decrease of NAS-score greater than or equal to 2
(p=0.04 vs placebo).
Early NASH patients with NAS=3 were not included in other recent NASH trials.
If the same is done in the GOLDEN-505 study, keeping patients with more severe
disease defined by NAS greater than or equal to 4 (n=202), GFT505 120mg
demonstrates a doubling of responders on the primary endpoint (22.4% vs 12.7%,
p=0.046, RR=1.9), thus providing evidence of a clinically meaningful benefit
in patients with more advanced disease.