GENFIT: Update on Regulatory and Clinical
Activities Amid the COVID-19 Pandemic
Lille (France), Cambridge
(Massachusetts, United States), March 31, 2020 – GENFIT (Nasdaq and
Euronext: GNFT), a late-stage
biopharmaceutical company dedicated to the discovery and
development of innovative therapeutic and diagnostic solutions in
metabolic and liver related diseases, today reported an update on
its regulatory and clinical activities in the context of the
COVID-19 pandemic.
The unprecedented spread of COVID-19 is
impacting the global health and business ecosystem, GENFIT
included. During this crisis, our priorities are to ensure the
safety and well-being of our employees, of the patients and
healthcare professionals involved in our clinical trials, as well
as the integrity of our ongoing clinical trials.
GENFIT is therefore monitoring the situation
closely and, in light of our priorities and in accordance with the
recently issued guidance documents of the U.S. Food and Drug
Administration (FDA) and European Medicines Agency, we have worked
with our contract research organizations, trial sites and
investigators to critically reassess all our existing programs.
RESOLVE-IT Phase 3 trial in NASH with
fibrosis continues
As announced previously, the first ~1000
patients required to support regulatory approval have completed
their final visits and the database related to that cohort was
locked at the end of February, as planned. The un-blinding of the
study and subsequent announcement of interim results will take
place after receipt and incorporation of insight from the FDA. We
do not currently anticipate that the COVID-19 situation will
significantly delay receipt of this feedback.
After careful consideration of the potential
benefits to NASH patients in continuing treatment, we have also
decided to continue the extension phase of RESOLVE-IT. Working with
our contract research organization, we have implemented appropriate
measures to ensure the safety of patients who are already
participating in the study: virtual clinic visits, local laboratory
assessment, home delivery of study drug, and halting the screening
of new patients. Additional measures may be implemented, as
required by the evolving COVID-19 situation.
Other trials are paused
Following guidance from regulatory authority
recommendations and prioritizing the safety of our clinical trial
participants, all phase 1 trials – which include pharmacokinetic,
food effect and bioequivalence studies – have been put on hold.
These studies are necessary to support the elafibranor NDA
submission for NASH.
Enrollment of patients in the PK/PD trial in
pediatric patients with NASH as well as the Phase 2 study
addressing liver fat have also been paused.
While our NASH combination and PBC programs both
continue with several work streams still being executed, we have
decided to put on hold the initiation of the Phase 2 combination
study, as well as that of the Phase 3 study in patients with
PBC.
All supporting activities pertaining to
continuation of ongoing studies or the initiation of new studies
will continue in order to minimize potential delays when the
pandemic crisis subsides.
NIS4 Diagnostic
Our diagnostic solution continues to be deployed
in the clinical research field through our commercial partner
Covance, a subsidiary of diagnostics leader LabCorp. While interest
in NIS4 is high, there may be some limits in test utilization due
to delays potentially experienced by some NIS4 clients as the
result of the current COVID-19 situation.
GENFIT teams are progressing the in-vitro
diagnostic (IVD) aspect of the program in parallel.
Supply chain
update
Although the COVID-19 pandemic is rapidly
evolving, and our plans may change accordingly, at this stage we do
not anticipate any supply disruption for any of our current or
planned studies. We have on hand sufficient supply of elafibranor
for all our clinical studies up to mid-2021, and we do not foresee
any issues with supply of raw materials and production of
commercial batches. Likewise, our partners and the GENFIT teams
have put in place contingency plans to manage the operational
aspects of our ongoing and planned trials, even under the current
conditions.
Employee update
Our employees are fully committed and are doing
their best to ensure business continuity during this crisis. The
measures we have deployed are fully aligned with governmental
measures recommended for impacted countries and will be adjusted as
the situation evolves. These measures enable GENFIT to pursue the
vast majority of our activities, while abiding by health
authorities’ sanitary recommendations: remote work has been enacted
for all compatible positions, social distancing measures are
applied for employees still working in the office, safety
protection procedures are enforced, and business travel is strictly
limited to that which is considered absolutely critical for the
Company’s operations.
ABOUT RESOLVE-IT
RESOLVE-IT is a phase 3 study evaluating the
efficacy and safety of elafibranor 120mg versus placebo in patients
with nonalcoholic steatohepatitis (NASH) and fibrosis. It is a
multicenter, randomized, double-blind, placebo-controlled study
with 2 arms. It is conducted under Subpart H (FDA) and conditional
approval (EMA). Treatment duration until interim analysis for
accelerated approval is 72 weeks.
ABOUT ELAFIBRANORElafibranor,
GENFIT’s lead pipeline therapeutic candidate, has been developed to
treat, in particular, nonalcoholic steatohepatitis (NASH), for
which it has been granted Fast Track Designation by FDA.
Elafibranor is an oral, once-daily, first-in-class drug
acting via dual agonism of peroxisome proliferator-activated
alpha/delta receptors. Elafibranor was granted a Breakthrough
Therapy Designation by FDA in this indication.
ABOUT NASH
NASH is a liver disease characterized by an
accumulation of fat (lipid droplets), along with inflammation and
degeneration of hepatocytes. The disease is associated with an
increased risk of cardiovascular disease along with long-term risk
for progression to cirrhosis, leading to liver insufficiency and
potential progression to liver cancer. NASH is a serious disease
that often carries no symptoms in its early stages, but if left
untreated can result in cirrhosis, cancer, and the need for liver
transplant. The prevalence of NASH is rapidly increasing as a
result of the growing obesity and diabetes epidemics and is
believed to affect as much as 12 percent of people in the U.S. and
six percent worldwide.
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.
ABOUT NIS4
GENFIT is developing NIS4, a blood-based
diagnostic test to identify patients with NASH and fibrosis
(F>2, NAS>4), who are the focus of current NASH clinical
trials. The NIS4 program is based on the in-house discovery of a
4-biomarker algorithm, and GENFIT is currently pursuing
commercialization of this test, which aims to be a validated
alternative to the liver biopsy. In January 2019, GENFIT signed a
licensing agreement with LabCorp® to make the NIS4 diagnostic kit
available in the clinical research field, and GENFIT plans to file
an application with the FDA for approval of NIS4 as an in vitro
diagnostic (IVD) .
ABOUT GENFIT
GENFIT is a late-stage biopharmaceutical company
dedicated to the discovery and development of innovative
therapeutic and diagnostic solutions in metabolic and liver related
diseases where there are considerable unmet medical needs,
corresponding to a lack of approved treatments. GENFIT is a leader
in the field of nuclear receptor-based drug discovery, with a rich
history and strong scientific heritage spanning almost two decades.
Its most advanced drug candidate, elafibranor, is currently being
evaluated in a pivotal Phase 3 clinical trial (“RESOLVE-IT”) as a
potential treatment for NASH, and GENFIT plans to initiate a Phase
3 clinical trial of elafibranor in PBC. As part of GENFIT’s
comprehensive approach to clinical management of patients with
NASH, the company is also developing a new, non-invasive
blood-based diagnostic test, NIS4, which, if approved, could enable
easier identification of patients with 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 in 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 timing of anticipated receipt of FDA insights
regarding elafibranor in NASH and incorporation of such insight,
appropriateness of safety measures in the continuing RESOLVE-IT
Phase 3 clinical trial, ability to continue supporting activities
and to minimize potential delays once the COVID-19 pandemic
subsides, potential for supply disruptions for our ongoing and
planned clinical studies and impact of the COVID-19 pandemic on our
operations and timelines. The use of certain words, including
“believe,” “potential,” “expect” and “will”, “provisional” 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 4 “Main Risks and Uncertainties” of the Company’s
2018 Registration Document filed with the AMF on February 27, 2019
under n° D.19-0078, 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 final
prospectus dated March 26, 2019, and subsequent filings and reports
filed with the AMF or SEC, or otherwise made public, by the
Company. 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: Update on Regulatory and Clinical Activities Amid the
COVID-19 Pandemic
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