Galectin Therapeutics Inc.
) carbohydrate-based galectin inhibitor GR-MD-02 is currently in
phase I development for the treatment of nonalcoholic
steatohepatitis (NASH) with advanced fibrosis. NASH is also known
as fatty liver disease.
Galectin Therapeutics recently announced preclinical data
showing an effect on a blood biomarker in an animal model of NASH
with fibrosis. Animals treated with GR-MD-02 showed 33%
reductions in hyaluronic acid, as compared to untreated
This study treated NASH-induced mice with a once weekly dose
of GR-MD-02 for a six-week period at four different doses (10,
30, and 60 mg/kg body weight). The treatment significantly
reduced the plasma levels of hyaluronic acid in the NASH mice.
The study also indicated that changes in tissue galectin-3 and
improvement in NASH histology do not correlate with blood levels
of galectin-3 in this model.
The preclinical data reveals that improvement in NASH and
fibrosis with GR-MD-02 treatment are correlated with plasma
levels of hyaluronic acid.
GR-MD-02 is currently in the first-in-human phase I trial,
which will evaluate single and multiple doses of GR-MD-02 for
evaluating the safety, tolerability and exploratory biomarkers
for efficacy in patients with fatty liver disease with advanced
The company completed enrolling patients in the first cohort
of the phase I study on GR-MD-02 on Jan 13, 2014. The company
might start a phase II study in late 2014 or early 2015 based on
phase I study results and expects phase II top-line data in the
first half of 2016 depending on the design of the study.
Non-alcoholic steatohepatitis (NASH) is expected to affect 9
million to 15 million people in the U.S. Galectin Therapeutics
has obtained Fast Track Designation from the U.S. Food and Drug
Administration (FDA) for the development of GR-MD-02 in Aug 2013,
for the treatment of NASH with advanced fibrosis.
Galectin Therapeutics has another candidate in its pipeline,
GM-CT-01 for the treatment of metastatic melanoma skin cancer.
GM-CT-01 is currently in a phase I/II study as a combination
therapy with a tumor vaccine in patients with advanced
Galectin Therapeutics carries a Zacks Rank #4 (Sell). Some
better-ranked players in the pharma industry include
Lannett Co. Inc.
). All the three stocks carry a Zacks Rank #1 (Strong Buy).
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