GENFIT Announces Publication of Positive Results from the Phase 2
Clinical Trial Evaluating Elafibranor in Patients with PBC in the
Journal of Hepatology
Lille, France; Cambridge, MA; February
09, 2021 - GENFIT (Nasdaq and Euronext:
GNFT), a late-stage biopharmaceutical company dedicated to
improving the lives of patients with metabolic and liver
diseases, today announced that the positive
results from the Phase 2 clinical trial evaluating elafibranor in
patients with Primary Biliary Cholangitis (PBC) with incomplete
response to ursodeoxycholic acid (UDCA) have been published in the
Journal of Hepatology.
Dr. Carol Addy, CMO at GENFIT, commented:
“These data support the potential for elafibranor as novel
treatment in PBC and confirm the rationale of evaluating our
compound in this disease in a pivotal Phase 3 trial. PBC remains a
disease with significant unmet medical needs, mostly because a
substantial number of patients have insufficient response or cannot
benefit from existing therapies. This publication reminds us that
research can give patients and healthcare professionals hope for
new therapeutic options. We seek to replicate the Phase 2 efficacy
and safety results in ELATIVE™, our Phase 3 clinical trial in PBC,
in the hope that we may improve the prospect of new treatment for
patients.”
These data show a clinically relevant
improvement on the primary and composite biochemical endpoints, a
positive trend on pruritus improvement, while maintaining a
favorable tolerability profile, all of which are supportive of the
conduct of ELATIVE™, a longer term, larger scale pivotal Phase 3
study to evaluate elafibranor in patients with PBC.
Dr. Jörn Schattenberg, Director
Metabolic Liver Research Program, University Medical Center, Mainz,
Germany added: “These promising findings along with
existing safety data derived from past clinical trials suggest
elafibranor is a promising development candidate as a potential
novel treatment for patients with PBC. Regulatory authorities know
the disease well and there remains an important unmet need to be
addressed as many patients at present remain without a long-term
therapeutic option.”
Based upon the Phase 2 data, elafibranor was
granted Breakthrough Therapy designation by the Food and Drug
Administration (FDA), as well as Orphan Drug designation by the FDA
and the European Medicines Agency (EMA). In September 2020,
GENFIT initiated enrollment of patients in ELATIVE™, a global
pivotal Phase 3 clinical trial to evaluate the efficacy and safety
of elafibranor in patients with PBC and an inadequate response to
UDCA. The randomized study (2:1, elafibranor: placebo) will
evaluate approximately 150 patients following 52 weeks of
treatment. Topline data are expected in Q1 2023.
Dr. Kris V. Kowdley, Director, Liver
Institute Northwest, Clinical Professor Elson S. Floyd College of
Medicine, Washington State University added: “These
encouraging Phase 2 data are particularly exciting as they
highlight a favorable trend in pruritus, which is a debilitating
symptom of PBC and one that significantly affects patients’ quality
of life. These data suggest that elafibranor is a promising drug
candidate, and I’m eager to see whether this trend becomes more
significant following longer-term administration, while maintaining
the favorable safety/tolerability profile we have seen in the Phase
2 trial.”
ABOUT GENFIT
GENFIT is a late-stage biopharmaceutical company
dedicated to improving the lives of patients with cholestatic and
metabolic chronic liver diseases. GENFIT is a pioneer in the field
of nuclear receptor-based drug discovery, with a rich history and
strong scientific heritage spanning more than two decades. GENFIT
is currently enrolling in ELATIVE™, a Phase 3 clinical trial
evaluating elafibranor in patients with Primary Biliary Cholangitis
(PBC). Elafibranor is an investigational compound that has not been
reviewed and has not received approval by any regulatory authority.
As part of GENFIT’s comprehensive approach to clinical management
of patients with liver disease, the Company is also developing
NIS4™, a new, non-invasive blood-based diagnostic technology which
could enable easier identification of patients with at-risk
NASH. NIS4™ technology has been licensed to LabCorp in the
U.S. and Canada for the development and commercialization of a
blood-based molecular diagnostic test powered by NIS4™ technology.
GENFIT has facilities in Lille and Paris, France, and Cambridge,
MA, USA. GENFIT is a publicly traded company listed on the Nasdaq
Global Select Market and on compartment B of Euronext’s regulated
market in Paris (Nasdaq and Euronext: GNFT). www.genfit.com
FORWARD LOOKING STATEMENTS
This press release contains certain
forward-looking statements with respect to GENFIT, including those
within the meaning of the Private Securities Litigation Reform Act
of 1995, with respect to GENFIT, including statements regarding the
ability to reproduce the Phase 2 PBC trial efficacy and safety
results in the ELATIVE Phase 3 clinical trial and expectations
regarding timing of the publication of topline data from the
ELATIVE Phase 3 trial. The use of certain words, including
“consider”, “contemplate”, “think”, “aim”, “expect”, “understand”,
“should”, “aspire”, “estimate”, “believe”, “wish”, “may”, “could”,
“allow”, “seek”, “encourage” or “have confidence” or (as the case
may be) the negative forms of such terms or any other variant of
such terms or other terms similar to them in meaning is intended to
identify forward-looking statements. Although the Company believes
its projections are based on reasonable expectations and
assumptions of the Company’s management, these forward-looking
statements are subject to numerous known and unknown 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 in relation to safety, biomarkers,
progression of, and results from, its ongoing and planned clinical
trials, review and approvals by regulatory authorities of its drug
and diagnostic candidates, exchange rate fluctuations and the
Company’s continued ability to raise capital to fund its
development, as well as those risks and uncertainties discussed or
identified in the Company’s public filings with the AMF, including
those listed in Chapter 2 “Main Risks and Uncertainties” of the
Company’s 2019 Universal Registration Document filed with the AMF
on 27 May 2020 under n° D.20-0503 and in Section 2 “Risk Factors”
of the Company’s Amendment to the Universal Registration Document
filed with the AMF on 22 December 2020 under n° D.20-0503-A01,
which are available on the Company’s website (www.genfit.com) and
on the website of the AMF (www.amf-france.org) and public filings
and reports filed with the U.S. Securities and Exchange Commission
(“SEC”) including the Company’s 2019 Annual Report on Form 20-F
filed with the SEC on May 27, 2020. In addition, even if the
Company’s results, performance, financial condition and liquidity,
and the development of the industry in which it operates are
consistent with such forward-looking statements, they may not be
predictive of results or developments in future periods.
These forward-looking statements speak only as of the date of
publication of this document. Other than as required by applicable
law, the Company does not undertake any obligation to update or
revise any forward-looking information or statements, whether as a
result of new information, future events or otherwise.
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
- GENFIT Announces Publication of Positive Results from the Phase
2 Clinical Trial Evaluating Elafibranor in Patients with PBC in the
Journal of Hepatology