Galectin Therapeutics Update on the Impact of COVID-19
April 02 2020 - 8:04AM
Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer
of therapeutics that target galectin proteins today provided an
update on the impact of the COVID-19 pandemic on the Company and
its clinical trial activities.
As the global COVID-19 pandemic continues to
quickly evolve, we have put measures in place intended to safeguard
the health of our employees in line with many other companies. In
doing so, we aim to do our part to help slow the spread of COVID-19
in our communities and protect our employees and their families,
all while continuing the critical work necessary to initiate and
conduct our NASH-RX clinical trial for patients with NASH
cirrhosis.
In accordance with guidance issued by the
Centers for Disease Control and Prevention (CDC), the World Health
Organization (WHO) and local authorities, our employees are working
remotely from home. We are now leveraging digital communication
technologies to continue important interactions with healthcare
professionals, patients and other stakeholders. We remain committed
to completing and filing the NASH-RX protocol with the US Food and
Drug Administration (FDA) in the near term. To date, we have
suffered no significant financial hardships, delays or loss of any
employees or contractors related to COVID-19.
The COVID-19 pandemic has substantially impacted
the global healthcare delivery system including the conduct of
clinical trials. As appropriate, many healthcare systems and
providers have understandably prioritized caring for those
suffering from COVID-19 and redirected resources in support of the
broader community currently. This burden on the healthcare system
has also impaired the ability of many clinical research centers to
start new studies, enroll new patients and/or continue ongoing
clinical trials. Most importantly, we must consider the risk to the
patients of asking them to leave their homes and travel in an
environment governmental authorities have deemed unsafe. At this
time and as previously communicated, we plan to initiate the
NASH-RX trial during the second quarter of 2020; however, this may
be impacted by the COVID-19 pandemic.
Galectin Therapeutics Inc. has developed several
overarching principles to guide its conduct of clinical research in
light of COVID-19. Number one among these is the safety of
patients, site personnel and our own employees. In addition,
several health authorities have provided guidance for the conduct
of clinical trials during this pandemic and suggestions related to
assuring study integrity and the value of the data. Following this
guidance, we can report the following actions and
developments:Galectin Therapeutics and the team at Covance, our
CRO, are focused on those activities that we can directly
control. For example, these include the completion of protocol and
associated documents for new clinical trials and filing of
protocols and associated documents with regulatory agencies, both
in the US and internationally. This also includes numerous
activities in conjunction with Covance and external vendors to
ensure all internal systems such as study databases,
adjudication systems, laboratory systems, data monitoring committee
charters and the like are fully ready when trial sites are
willing to restart their clinical research activities.
Clinical supply distribution and related
activities with our external vendors are so far only minimally
impacted. However, this could change in the coming weeks and
months. Fortunately, we currently have an adequate supply of
belapectin. External activities directed toward specific site
start-up activities such as pre-study visits (using virtual
techniques) by Covance employees, site contracting activities,
training activities and site-directed ethic committee submissions
will continue moving forward in conjunction with the site
principal investigators and site coordinators, as well as with
managers of the NASH site-specific network we are using.
We remain strongly committed to initiating our
adaptive Phase 3 trial as soon as reasonably possible considering
COVID-19. We are doing everything we can to minimize disruption and
delays in site-related activities and patient enrollment and
striving to do so in a safe and considerate manner. Further
information will be forthcoming as we all navigate this
situation.
Our hearts and thoughts go out to everyone whose
lives have been seriously affected by COVID-19, and to our medical
professionals on the front lines who are combating the
virus.
About Galectin
Therapeutics Galectin Therapeutics is dedicated to
developing novel therapies to improve the lives of patients with
chronic liver disease and cancer. Galectin’s lead drug belapectin
(formerly known as GR-MD-02) is a carbohydrate-based drug that
inhibits the galectin-3 protein which is directly involved in
multiple inflammatory, fibrotic, and malignant diseases, for which
it has Fast Track designation by the U.S. Food and Drug
Administration. The lead development program is in non-alcoholic
steatohepatitis (NASH) with cirrhosis, the most advanced form of
NASH-related fibrosis. This is the most common liver disease and
one of the largest drug development opportunities available today.
Additional development programs are in treatment of combination
immunotherapy for advanced melanoma and other malignancies.
Advancement of these additional clinical programs is largely
dependent on finding a suitable partner. Galectin seeks to leverage
extensive scientific and development expertise as well as
established relationships with external sources to achieve
cost-effective and efficient development. Additional information is
available
at www.galectintherapeutics.com.
Forward Looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
These statements relate to future events or future financial
performance, and use words such as “may,” “estimate,” “could,”
“expect” and others. They are based on management’s current
expectations and are subject to factors and uncertainties that
could cause actual results to differ materially from those
described in the statements. These statements include those
regarding the hope that Galectin’s development program for
belapectin will lead to the first therapy for the treatment
of fatty liver disease with cirrhosis and those regarding the hope
that our lead compounds will be successful in cancer immunotherapy
and in other therapeutic indications. Factors that could cause
actual performance to differ materially from those discussed in the
forward-looking statements include, among others, that trial
endpoints required by the FDA may not be achieved; Galectin may not
be successful in developing effective treatments and/or obtaining
the requisite approvals for the use of belapectin or any of its
other drugs in development; the Company may not be successful in
scaling up manufacturing and meeting requirements related to
chemistry, manufacturing and control matters; the Company’s
currently planned clinical trial and any future clinical studies as
modified to meet the requirements of the FDA may not produce
positive results in a timely fashion, if at all, and could require
larger and longer trials, which would be time consuming and costly;
plans regarding development, approval and marketing of any of
Galectin’s drugs are subject to change at any time based on the
changing needs of the Company as determined by management and
regulatory agencies; regardless of the results of any of its
development programs, Galectin may be unsuccessful in developing
partnerships with other companies or raising additional capital
that would allow it to further develop and/or fund any studies or
trials. Galectin has incurred operating losses since inception, and
its ability to successfully develop and market drugs may be
impacted by its ability to manage costs and finance continuing
operations. Global factors such as coronavirus may limit access to
NASH patient populations around the globe and slow trial enrollment
and prolong the duration of the trial and significantly impact
associated costs. For a discussion of additional factors
impacting Galectin’s business, see the Company’s Annual Report on
Form 10-K for the year ended December 31, 2019, and subsequent
filings with the SEC. You should not place undue reliance on
forward-looking statements. Although subsequent events may cause
its views to change, management disclaims any obligation to update
forward-looking statements.
Company Contact:Jack Callicutt, Chief Financial
Officer(678) 620-3186ir@galectintherapeutics.com
Galectin Therapeutics and its associated logo is
a registered trademark of Galectin Therapeutics Inc. Belapectin is
the USAN assigned name for Galectin Therapeutics’ galectin-3
inhibitor GR-MD-02
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