GENFIT Announces First Patient First Visit for ELATIVE Phase 3
Study Evaluating Elafibranor in PBC
Lille, France; Cambridge, M.A.;
September 24, 2020 - GENFIT (Nasdaq and Euronext:
GNFT), a late-stage biopharmaceutical company dedicated to
improving the lives of patients with metabolic and liver
diseases, today announced the first patient first
visit for ELATIVE, the global, pivotal, Phase 3 study evaluating
elafibranor in Primary Biliary Cholangitis (PBC).
ELATIVE is a randomized, double blind,
placebo-controlled, global multicenter Phase 3 study evaluating the
efficacy and safety of elafibranor, a dual PPAR alpha and delta
agonist, in PBC. The primary endpoint will evaluate the response to
treatment defined by alkaline phosphatase (ALP) < 1.67 x upper
limit of normal (ULN), total bilirubin (TB) ≤ ULN and ALP decrease
≥ 15%. Key secondary endpoints will include the effect of
elafibranor on normalization of ALP and change in pruritus from
baseline. The randomized study (2:1, elafibranor:placebo) will
evaluate approximately 150 patients with inadequate response to
ursodeoxycholic acid (UDCA) following 52 weeks of treatment.
PBC is a severe cholestatic liver disease that
impacts and gradually destroys the bile ducts, leading to
inflammation and scarring in the liver. This condition, if left
untreated, can lead to cirrhosis, liver failure and may ultimately
require liver transplantation. There is no existing cure for PBC,
and current therapies are only able to potentially slow the
progression of the disease. Approximately half1 of patients with
PBC are unable to benefit from existing therapies due to lack of
response or intolerable side effects.
Kris V. Kowdley, MD, Director at Liver
Institute Northwest, Seattle, WA, and Clinical Professor at the
Elson S. Floyd College of Medicine, Washington State
University, commented: “A significant percentage of
patients with PBC are in need of additional therapies and face a
reduced quality of life due to the debilitating disease symptoms
and treatment side effects, including pruritus. This leaves
healthcare professionals with limited therapeutic options and
ongoing need for new therapies, given that in the absence of
treatment the median survival for some patients presenting with
symptoms may be as short as seven to eight years.2 The development
of a new promising therapy with the potential to address both
cholestasis and pruritus provides hope for patients and healthcare
providers in treating the PBC population.”
In 2018, GENFIT announced positive Phase 2 data
in PBC, where elafibranor showed a clinically relevant improvement
on the primary and composite biochemical endpoints providing early
confirmation of efficacy, a positive trend on pruritus improvement,
while maintaining a favorable tolerability profile. Based upon
these 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).
Pascal Prigent, CEO at GENFIT,
added: “I am proud of the GENFIT team, who have worked hard to
achieve the first patient first visit for ELATIVE amidst the
ongoing challenges presented by the COVID-19 global pandemic. This
is a significant milestone and it means that we are now a step
closer to hopefully bringing patients and caregivers a promising
option to treat this debilitating disease and its symptoms. We see
an important potential for elafibranor in PBC and will provide
further information at the upcoming Corporate Update on September
30."
ABOUT PBC
Primary biliary cholangitis (PBC) is a chronic,
autoimmune 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. Elafibranor, currently in a phase 3
clinical trial for PBC (ELATIVE), has shown promising results for
the treatment of PBC in a Phase 2 clinical trial, and was granted
Breakthrough Therapy designation by the FDA and Orphan Drug
designation by the FDA and EMA in this condition.
ABOUT GENFIT
GENFIT is a late-stage biopharmaceutical company
dedicated to improving the lives of patients with metabolic and
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 has
initiated a Phase 3 clinical trial of elafibranor in patients with
PBC. 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, if approved, could enable easier identification
of patients with at-risk NASH. With facilities in Lille and Paris,
France, and Cambridge, MA, USA, the Company has approximately 200
employees. 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, including those within the meaning of
the Private Securities Litigation Reform Act of 1995, with respect
to GENFIT, including statements regarding the potential of
elafibranor in PBC. The use of certain words, including
“believe,” “potential,” “expect” and “will” and similar
expressions, is intended to identify forward-looking
statements. Although the Company believes its expectations
are based on the current expectations and reasonable 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 related 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 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
French Autorité des marchés financiers (“AMF”), including those
listed in Section 2.1 “Main Risks and Uncertainties” of the
Company’s 2019 Universal Registration Document filed with the AMF
on May 27, 2020 under n° D.20-0503, which is available on GENFIT’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 20-F dated 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.
GENFIT CONTACT
GENFIT | Investors
Naomi EICHENBAUM – Investor Relations | Tel: +1
(617) 714 5252 | investors@genfit.com
PRESS RELATIONS | Media
Hélène LAVIN – Press Relations | Tel: +3 33 2016
4000 | helene.lavin@genfit.com
GENFIT | 885 Avenue Eugène Avinée, 59120
Loos - FRANCE | +333 2016 4000 |
www.genfit.com
1 Shah RA, Kowdley KV. Current and potential treatments
for primary biliary cholangitis. Lancet Gastroenterol Hepatol. 2020
Mar;5(3):306-315. doi: 10.1016/S2468-1253(19)30343-7. Epub 2019 Dec
2. PMID: 31806572. 2 Lindor et al. Hepatology 2019.
- GENFIT Announces First Patient First Visit for ELATIVE Phase 3
Study Evaluating Elafibranor in PBC