Update on GALT's GR-MD-02 - Analyst Blog
24 Januar 2014 - 12:50AM
Zacks
Galectin Therapeutics Inc.’s (GALT)
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 animals.
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 fibrosis.
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
melanoma.
Galectin Therapeutics carries a Zacks Rank #4 (Sell). Some
better-ranked players in the pharma industry include
Actelion Ltd. (ALIOF), Endocyte,
Inc. (ECYT) and Lannett Co. Inc. (LCI).
All the three stocks carry a Zacks Rank #1 (Strong Buy).
ACTELION LTD (ALIOF): Get Free Report
ENDOCYTE INC (ECYT): Free Stock Analysis Report
GALECTIN THERAP (GALT): Get Free Report
LANNETT INC (LCI): Free Stock Analysis Report
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