Galectin Therapeutics Could Triple On Fibrosis And Cirrhosis Treatment: H.C. Wainwright

• Shares of Galectin Therapeutics, Inc. GALT have declined more than 32 percent, year to date.
• HC Wainwright’s Yi Chen has initiated coverage of Galectin Therapeutics with a Buy rating and price target of $7.
• The company is developing a treatment for nonalcoholic steatohepatitis (NASH) cirrhosis, which could address a potentially multi-billion dollar market.

The agents being developed by Galectin Therapeutics could have applications for fibrosis causes by other diseases, including cancer. According to Chen, the preclinical and Phase 1 results have so fast been promising, with the lead drug candidate, GR-MD-02, demonstrating the ability to prevent and reverse cirrhosis and fibrosis.

According to the HC Wainwright report, “Phase 1 trial conducted in biopsy-proven NASH patients with advanced hepatic fibrosis showed that four doses of the drug, at 8 mg/kg via intravenous administration over a roughly 40-day period, was safe and well tolerated without serious or treatment-emergent adverse events.”

In addition, the trial showed statistically significant decline in liver stiffness and serum alpha-2 macroglobulin, implying that longer term therapy with the drug could lead to fibrosis improvement.

Given that a benign safety profile is crucial for the treatment especially of advanced stage NASH patients, Chen noted that “the toxicity potential of GR-MD-02 is low because carbohydrates are typically metabolized to harmless compounds.”

The company also launched its Phase 2 study of GR-MD-02 in June 2015 on NASH patients with cirrhosis with the primary endpoint being a change in the hepatic venous pressure gradient, which is the “FDA-approved surrogate endpoint for NASH cirrhosis.”

Topline data for the Phase 2 trial is expected in 4Q17, while Galectin Therapeutics has also initiated a smaller trial in September 2015 to assess the drug for NASH patients with advanced fibrosis. Data for the latter trial is expected in 3Q16.

Chen expects the drug to demonstrate “positive efficacy” in these studies.