Update on GALT's GR-MD-02 - Analyst Blog

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).

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