Data Collected by Exalenz Bioscience in Galectin Therapeutics’ Phase 2 NASH-CX Trial of GR-MD-02 to Be Presented at AASLD A...
November 05 2018 - 8:00AM
Galectin Therapeutics Inc. (NASDAQ:GALT), the leading
developer of therapeutics that target galectin proteins, today
announced that an abstract based on results obtained in Galectin
Therapeutics’ NASH-CX Phase 2 Clinical Trial has been accepted for
a poster presentation by Exalenz Bioscience at The Liver Meeting,
the annual meeting of the American Association for the Study of
Liver Diseases (AASLD) in San Francisco on November 9-13, 2018. The
poster presentation is titled “The noninvasive point of care MBT
accurately predicts decompensation events better than MELD in
compensated (MELD<15) NASH cirrhotics” authored by Naga
Chalasani, et al. The poster illustrates Exalenz Bioscience’s
13C-Methacetin Breath Test’s (MBT) ability to predict
decompensation in compensated NASH cirrhotics. MBT was performed on
160 patients with compensated NASH cirrhosis (i.e. no prior
variceal hemorrhage, ascites or hepatic encephalopathy) in Galectin
Therapeutics’ NASH-CX Phase 2 Clinical Trial. All were followed
prospectively for decompensation.
The study showed that MBT, which measures liver function,
strongly predicts liver decompensation in patients with compensated
NASH cirrhosis. The data suggest that this non-invasive, valid,
operator-independent, point-of-care tool is safe and may be a more
effective clinical tool than instruments currently used to help
identify patients at increased risk for hepatic decompensation.
The poster itself will be released in accordance with AASLD’s
policies.
Saturday, November 10, 2018 at 2:00 p.m.
PSTPoster Session IIMoscone
Center, Hall C “The noninvasive point of care MBT
accurately predicts decompensation events better than MELD in
compensated (MELD<15) NASH cirrhotics.” N. Chalasani, et al.
Abstract #1337
About NASH-CX Phase 2b Trial
Galectin Therapeutics announced top-line results from its
NASH-CX Phase 2 trial in December 2017. The Company is proceeding
with plans for a Phase 3 clinical trial program with its galectin-3
inhibitor GR-MD-02 in NASH cirrhosis, incorporating advice and
guidance obtained in a meeting with the FDA. Details of the Phase 3
clinical trial design, including projected timings and costs, will
be announced once the planning phase has been completed and the
Company has submitted a final clinical trial protocol with the
FDA.
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 (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. 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
severe atopic dermatitis, moderate-to-severe plaque psoriasis, and
in 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.
About Exalenz BioscienceExalenz Bioscience
develops and markets diagnostic tests and monitoring systems that
use the breath to diagnose and help manage gastrointestinal and
liver conditions. The company’s flagship BreathID® Hp offers the
most efficient and accurate test for detection of H. pylori
bacteria, associated with various illnesses including gastric
cancer, and is already in use in over 400 U.S. medical centers and
major labs across the country. The BreathID 13C-methacetin breath
test (MBT) is a sensitive, noninvasive, point of care tool that
measures the microsomal function of the liver. Exalenz holds
regulatory approvals in Europe, the United States, China and Israel
for H. pylori detection and is currently evaluating additional
applications of the BreathID platform, including MBT in the
detection of CSPH in patients with NASH. Additional information is
available at www.exalenz.com.
Contacts:Jack Callicutt, Chief Financial
Officer(678) 620-3186ir@galectintherapeutics.com
Media Contact: Gregory FCALeigh Minnier, Vice
President610-228-2108leigh@gregoryfca.com
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