Galectin Therapeutics
GALT, the leading developer of therapeutics that target galectin
proteins to treat fibrosis and cancer, announced today that a preclinical
study in a mouse model of NASH (non-alcoholic steatohepatitis, or fatty liver
disease) demonstrated that oral administration of the Company's lead
galectin-3 inhibitor, GR-MD-02, resulted in significant disease improvement.
Diabetic mice, fed a high fat diet to induce NASH, were treated after the
development of disease with either a vehicle control (n=8) or GR-MD-02 (n=9)
administered orally five days out of seven for a total of four weeks. The
liver weight, liver-to-body weight ratio, and plasma triglyceride levels were
significantly reduced in the GR-MD-02 treated animals as compared to vehicle
control animals (p<0.05). Blood indicators of liver damage, including plasma
AST (aspartate aminotransferase), plasma ALT (alanine aminotransferase), and
plasma total bilirubin (TB) also demonstrated a statistically significant
reduction following oral treatment with GR-MD-02 and, in fact, levels were
reduced back to near normal levels (see accompanying figure here). AST, ALT,
and TB in normal animals (140 ± 86 U/L, 33 ± 8 U/L, 0.4 ± 0.0 mg/dL) were
increased in the NASH animals treated with vehicle (293 ± 59 U/L, 87 ± 16 U/L,
0.56 ± 0.1 mg/dL) and were significantly reduced with oral GR-MD-02 treatment
(159 ± 27 U/L, p<0.01; 46 ± 12 U/L, p<0.01; 0.4 ± 0.1 mg/dL, p<0.001). Each of
these blood biomarkers indicate liver injury that improved with treatment.
Finally, fibrosis of the liver was significantly reduced with treatment with
GR-MD-02, as indicated by the liver hydroxyproline content, a biochemical
marker of collagen in the liver. Liver hydroxyproline content in the normal
liver (0.48 ± 0.07 µg/mg total protein) was increased in the NASH animals
treated with vehicle (0.76 ± 0.14 µg/mg total protein) and was significantly
reduced with oral GR-MD-02 treatment (0.56 ± 0.12 µg/mg total protein,
p<0.01).
"Oral activity of GR-MD-02 in this established preclinical model of NASH
represents an important step in the development of galectin inhibitors and
complements our ongoing clinical program of intravenous administration in
patients with NASH with advanced fibrosis," said Dr. Peter G. Traber,
President, Chief Executive Officer, and Chief Medical Officer of Galectin
Therapeutics Inc. "We have evaluated various established technology platforms
and are currently developing oral formulations with a contracted firm with the
goal of developing an oral formulation for human studies as a follow on to our
current clinical development program."
The Company has an ongoing clinical trial of GR-MD-02 titled, "A Multi-Center,
Partially Blinded, Maximum Tolerated Multiple Dose Escalation, Phase 1
Clinical Trial to Evaluate the Safety of GR-MD-02 in Subjects with
Non-Alcoholic Steatohepatitis (NASH) with Advanced Hepatic Fibrosis." Trial
design details can be found at
http://clinicaltrials.gov/ct2/show/NCT01899859?term=gt-020&rank=1. In 2013,
Galectin Therapeutics received Fast Track designation from the FDA for this
clinical development program. FDA grants Fast Track designation to help
expedite review and approval of drugs in development that treat serious or
life threatening diseases and fill an unmet medical need.
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