GENFIT: Positive
Phase 2 Results from Study of Elafibranor in Primary Biliary
Cholangitis
-
Elafibranor successfully meets
primary endpoint with high statistical significance of
p<0.001
-
Substantial reductions in
alkaline phosphatase in patients receiving elafibranor; 52% (80 mg)
and 44% (120 mg) when compared to placebo
-
Significant response rate on
composite endpoint used for regulatory approval, with 67% (80 mg)
and 79% (120 mg) responders vs 6.7% for placebo
(p</=0.001)
-
Potential for improved efficacy
and tolerability compared to existing second-line PBC therapy,
supports advancement to the next stage of development
Lille (France),
Cambridge (Massachusetts, United States), December 6, 2018 -
GENFIT (Euronext: GNFT - ISIN: FR0004163111), a biopharmaceutical
company focused on discovering and developing drug candidates and
diagnostic solutions targeting liver diseases, in particular those
of metabolic origin, and hepatobiliary diseases, today announced
positive results from its Phase 2 study of elafibranor in patients
with primary biliary cholangitis (PBC), a chronic liver
disease.
This trial was a multicenter (US
and Europe), double-blind, randomized, placebo-controlled, 12-week
treatment, Phase 2 study to evaluate the efficacy and safety of
elafibranor (80 mg and 120 mg once-daily) in adult patients with
PBC who had an inadequate response to ursodeoxycholic acid
(UDCA).
The primary endpoint of "Change at
week 12 in serum alkaline phosphatase (ALP) from baseline" was met.
Both elafibranor doses demonstrated significant decrease in mean
ALP: -48% for 80 mg -41% for 120 mg with +3% increase for
placebo leading to highly significant treatment effect versus
placebo: -52% for 80 mg (p<0.001) and -44% for 120 mg
(p<0.001).
A key secondary endpoint was the
responder rate for patients achieving the composite endpoint of
serum ALP <1.67xULN, an ALP decrease >15%, and total
bilirubin (TB) <ULN. On this endpoint, elafibranor achieved the
substantially higher response rates of 67% for 80 mg and 79% for
120 mg as compared to 6.7% for placebo (p=0.001 and
p<0.001, respectively). ALP is an established surrogate marker
of disease progression in PBC, and this composite endpoint has been
previously used for regulatory approval.
Alongside substantial reductions
in ALP, in both elafibranor-treated groups, patients showed
improvement in other PBC markers such as gamma-glutamyl transferase
and metabolic markers such as total cholesterol, low-density
lipoprotein-C, and triglycerides. Improvement in pruritus was
observed and will be confirmed in a study of longer duration.
Treatment with elafibranor was generally well-tolerated, with
similar adverse events across the treatment and placebo groups.
Dr. Velimir A.
Luketic, MD, Division of Gastroenterology, Hepatology and Nutrition
Virginia Commonwealth University School of Medicine, Richmond, VA
(USA), commented: "A substantial number of
patients do not benefit from the currently available therapies -
UDCA or OCA - either because of lack of response or intolerable
side effects. The data emerging from this clinical trial are very
impressive, particularly the substantial reduction in ALP in just
12 weeks."
Dr. Jörn
Schattenberg, MD, Division of Gastroenterology and Hepatology,
University Medical Center, Mainz (Germany), further added:
"The study data are impressive and support the
rationale for elafibranor's PPAR alpha/delta approach in PBC. Not
only does elafibranor greatly reduce ALP, which is arguably the
most important prognostic marker for PBC patients, but it also
improves many other biochemical parameters and may reduce pruritus.
With these benefits, elafibranor has the potential to offer
patients significant advantages over existing treatments."
Jean-François
Mouney, Chairman & CEO of GENFIT, added: "We are thrilled with the results of our Phase 2 trial. We
believe the strength of evidence on the surrogate endpoint for
registration as well as the potential benefits on itching qualify
the program to rapidly advance into Phase 3 in PBC. This trial
strongly supports elafibranor, our dual PPAR alpha & delta
agonist in PBC, to treat a vast majority of target patients while
potentially improving their quality of life. We thank all of the
patients, patient families, and investigators of the Phase 2 trial
for their dedication".
About
elafibranor
Elafibranor is GENFIT's lead
pipeline product candidate. Elafibranor is an oral once-daily
treatment, and a first-in-class drug candidate acting via dual
peroxisome proliferator-activated alpha/delta pathways developed to
treat, in particular, nonalcoholic steatohepatitis (NASH).
Elafibranor is believed to address multiple facets of NASH,
including inflammation, insulin sensitivity, lipid/metabolic
profile, and liver markers. Elafibranor also presents a
particularly interesting profile to potentially treat PBC, a rare
liver disease.
About PBC
"PBC", or Primary Biliary
Cholangitis, is a chronic disease in which bile ducts in the liver
are gradually destroyed. The damage to bile ducts can inhibit the
liver's ability to rid the body of toxins, and can lead to scarring
of liver tissue known as cirrhosis.
About
GENFIT
GENFIT is a biopharmaceutical
company focused on discovering and developing drug candidates and
diagnostic solutions targeting liver diseases, in particular those
of metabolic origin, and hepatobiliary diseases. GENFIT
concentrates its R&D efforts in areas of high unmet medical
needs corresponding to a lack of approved treatments. GENFIT's lead
proprietary compound, elafibranor, is a drug candidate currently
being evaluated in one of the most advanced Phase 3 studies
worldwide ("RESOLVE-IT") in nonalcoholic steatohepatitis (NASH),
considered by regulatory authorities as a medical emergency because
it is silent, with potentially severe consequences, and with a
prevalence on the rise. It is also being evaluated in a Phase 2
study in Primary Biliary Cholangitis (PBC), a chronic liver
disease. As part of its comprehensive approach to clinical
management of NASH patients, GENFIT is conducting an ambitious
discovery and development program aimed at providing patients and
physicians with a blood-based test for the diagnosis of NASH, i.e.
non-invasive and easy-to-access. With facilities in Lille and
Paris, France, and Cambridge, MA (USA), the Company has
approximately 150 employees. GENFIT is a public company listed in
compartment B of Euronext's regulated market in Paris (Euronext:
GNFT - ISIN: FR0004163111). www.genfit.com
FORWARD LOOKING
STATEMENT/DISCLAIMER
This press release contains
certain forward-looking statements. Although the Company believes
its expectations are based on reasonable assumptions, these
forward-looking statements are subject to numerous risks and
uncertainties, which could cause actual results to differ
materially from those expressed in, or implied or projected by, the
forward-looking statements. These risks and uncertainties include
among other things, the uncertainties inherent in research and
development, including related to biomarkers, progression of, and
results from, its ongoing and planned clinical trials, review and
approvals by regulatory authorities, such as the FDA or the EMA, of
its drug and diagnostic candidates, the success of any inlicensing
strategies, the Company's continued ability to raise capital to
fund its development, as well as those discussed or identified in
the Company's public filings with the AMF, including those listed
in Section 4 "Main Risks and Uncertainties" of the Company's 2017
Registration Document registered with the French Autorité des
marchés financiers on April 27, 2018 under n° R.18-032, which is
available on GENFIT's website (www.genfit.com) and on the website
of the AMF (www.amf-france.org) and as updated by the 2018 Half
Year Business and Financial Report and available on the Investors
page of GENFIT's website. Other than as required by applicable law,
the Company does not undertake any obligation to update or revise
any forward-looking information or statements. This press release
and the information contained herein do not constitute an offer to
sell or a solicitation of an offer to buy or subscribe to shares in
GENFIT in any country. This press release has been prepared in both
French and English. In the event of any differences between the two
texts, the French language version shall supersede.
CONTACT
GENFIT |
Investors
Naomi EICHENBAUM - Investor Relations
| Tel: +1 (617) 714 5252 | investors@genfit.com
PRESS RELATIONS
| Media
Hélène LAVIN - Press relations | Tel:
+333 2016 4000 | helene.lavin@genfit.com
GENFIT | 885 Avenue Eugène
Avinée, 59120 Loos - FRANCE | +333 2016 4000 |
www.genfit.com
2018.12.06 - PR PBC
This
announcement is distributed by West Corporation on behalf of West
Corporation clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: GENFIT via Globenewswire
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