Galectin Therapeutics Inc. (NASDAQ:GALT), the leading
developer of therapeutics that target galectin-3, today announced
that it will share five scientific presentations at The Liver
Meeting™ 2022, hosted by the American Association for the Study of
Liver Diseases (AASLD), to be held November 4-8, 2022, in
Washington, D.C.
“For the sake of our patients, we need to bring more attention
to liver cirrhosis and, particularly, to portal hypertension, a
clinically relevant complication of the disease for which no
etiologic treatment exists,” said Pol Boudes, M.D., Chief Medical
Officer of Galectin Therapeutics. “ Early therapeutic intervention
to counteract the process of portal hypertension increases the
chance of success, and this is exactly what we are trying to do
with our candidate drug Belapectin, a galectin-3 inhibitor. This
year at AASLD Liver Meeting, we will share more information on the
patient population we are recruiting for our global NAVIGATE phase
2b/3 study; our adjudication process for esophago-gastric
endoscopies, an essential element in our objective to demonstrate
that belapectin can prevent the development of esophageal varices;
and the mechanism of action of the drug. We are also happy to share
with the medical community new data regarding a non-invasive test
(NIT) and liver histology reading with artificial intelligence (AI)
in patients affected by NASH cirrhosis and portal
hypertension.”
Abstracts will be available for viewing by attendees on the
AASLD website and are also featured in the October supplement to
the AASLD journal, Hepatology.
Presentation Details
Title: Prevalence of esophageal and
gastric varices in patients with compensated non-alcoholic
steatohepatitis (NASH) cirrhosis and portal hypertension. Data from
the NAVIGATE study
Abstract Number: 2329Authors: Boudes Pol, Alkhouri Naim, Ladron
de Guevara Cetina Laura, Elgouhari Hesham, Mena Edward,
Ortiz-Lasanta Grisell, Lawitz Eric, Moore Ann, Borg Brian,
Noureddin Mazen, Lucas Kathryn, Vuppalanchi Raj, Reiss Gary,
Schiefke Ingolf, Safadi Rifat, Shiffman Mitchell, Behari Jaideep,
Patel Chirag, Ben-Ari Ziv, Halegoua-De Marzio Dina, Patel Pankaj,
Patel Bhaktasharan, Caldwell Stephen, Ghalib Reem, Kayali Zeid,
Vierling John, Williams Alonzo, Aazami Hessam, and Mills-Wilson
Marla, for the NAVIGATE study group.Date: Saturday, November 5,
2022Time: 1:00 pm – 2:00 pm ET
Title: Biochemical and imaging profiles
in 271 patients with compensated NASH cirrhosis and clinically
suspected portal hypertension: an ongoing prospective
cohort
Abstract Number: 2337Authors: Boudes P, Alkhouri N, Elgouhari H,
Lucas K, Lawitz E, Borg B, Vuppalanchi R, Behari J, Patel C,
Noureddin M, Reiss G, Halegoua-De Marzio D, Caldwell S, Ghalib R,
Landaverde C, Patel P, Shiffman M, Moore A, Kopaczewski J,
Mills-Wilson M, for the NAVIGATE study groupDate: Saturday,
November 5, 2022Time: 1:00 pm – 2:00 pm ET
Title: Hepatic Expression of
Galectin-3, a Pro-fibrotic and Pro-inflammatory Marker – An
Immunohistochemical Survey
Publication Number: 1407Authors: Zachary D. Goodman, MD, PhD;
Ezra Lowe, PhD; Pol F. Boudes, MD, Inova Health System, Fall
Church, VA, USA, Galectin Therapeutics, Norcross, GA, USADate:
Friday, November 4, 2022Time: 12:00 pm – 1:00 pm ET
Title: Clinical utility of the ELF
score in compensated NASH cirrhotic patients with portal
hypertension
Publication Number: 2319Authors: Boudes PF, Lowe E, Galectin
TherapeuticsDate: Saturday, November 5, 2022Time: 1:00 pm – 2:00 pm
ET
Title: Histological correlation with
portal pressures and varices in NASH cirrhosis using quantitative
digital pathology
Publication Number: 36696Authors: Mazen Noureddin, Dean Tai,
Elaine L. K. Chng, Yayun Ren, Pol Boudes, Harold Shlevin, Stephen
A. Harrison, Naga P. Chalasani, Zachary GoodmanDate: Available as
ePoster
About Belapectin
Belapectin is a complex carbohydrate drug that targets
galectin-3, a critical protein in the pathogenesis of NASH and
fibrosis. Galectin-3 plays a major role in diseases that involve
scarring of organs, including fibrotic disorders of the liver,
lung, kidney, heart and vascular system. Belapectin binds to
galectin-3 and disrupts its function. Preclinical data in animals
have shown that belapectin has robust treatment effects in
reversing liver fibrosis and cirrhosis. A Phase 2 study showed
belapectin may prevent the development of esophageal varices in
NASH cirrhosis, and these results provide the basis for the conduct
of the NAVIGATE trial. The NAVIGATE trial (www.NAVIGATEnash.com),
titled “A Seamless Adaptive Phase 2b/3, Double-Blind, Randomized,
Placebo-controlled Multicenter, International Study Evaluating the
Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of
Esophageal Varices in NASH Cirrhosis,” began enrolling patients in
June 2020, and is posted on www.clinicaltrials.gov (NCT04365868).
Galectin-3 has a significant role in cancer, and the Company has
supported a Phase 1b study in combined immunotherapy of belapectin
and KEYTRUDA in advanced melanoma and in head and neck cancer. This
trial provided a strong rationale for moving forward into a
Company-sponsored Phase 2 development program, which the company is
exploring.
About the American
Association for
the Study of
Liver Diseases (AASLD)
AASLD is the leading organization of scientists and health care
professionals committed to preventing and curing liver disease.
AASLD fosters research that leads to improved treatment options for
millions of liver disease patients. It also advances the science
and practice of hepatology through educational conferences,
training programs, professional publications, and partnerships with
government agencies and sister societies. AASLD’s annual scientific
conference, The Liver Meeting™, is the world’s premier meeting on
liver disease, bringing together clinicians, associates, and
scientists from around the world to exchange information on the
latest research, discuss new developments in liver treatment and
transplantation, and network with leading experts in the field of
hepatology.
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 for
NASH with advanced fibrosis. 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 Statements
This 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 current
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 continue to impact 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, 2021, 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.
Source: Galectin Therapeutics Inc.
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