Galectin Posts Positive Preclinical NASH Data

Galectin Therapeutics has published new preclinical data demonstrating that its galectin-inhibiting drugs — GR-MD-02 and GM-CT-01 — demonstrate positive therapeutic effects on nonalcoholic steatohepatitis (NASH, or fatty liver disease) with fibrosis. The results were published in the article, “Therapy of Experimental NASH and Fibrosis with Galectin Inhibitors,” in the peer-reviewed, open-access journal PLOS ONE.

In the study, NASH-induced mice were treated with GM-CT-01 and GR-MD-02 at two different points, early fibrosis and later more severe fibrosis. The studies evaluated twice-weekly, and dose-escalation of once weekly by intravenous administration, as well as evaluated different routes of administration, including intravenous, subcutaneous and oral.

Results revealed that treatment with GR-MD-02 significantly improved NASH activity and reduced fibrosis including prevention of accumulation of collagen and/or reduced accumulated collagen in the liver. Similar effects were seen with GM-CT-01 but with approximately four-fold lower potency than GR-MD-02. The data also show reduction in galectin-3 expression and other inflammatory biomarkers.

GM-CT-01 and GR-MD-02 are proprietary molecules that bind to and inhibit galectin proteins, predominantly galectin-3. Six of eight patients have been enrolled and infused in cohort 1 of a blinded Phase I clinical trial of GR-MD-02 for patients with NASH with advanced fibrosis. Enrollment is ongoing and no serious adverse events have been reported. The Phase I first-in-man study is evaluating the safety, tolerability, pharmacokinetics and exploratory biomarkers for efficacy for single and multiple doses of GR-MD-02 when administered to patients with fatty liver disease with advanced fibrosis. Clinical data from the first cohort is expected early in 2014.