August 12, 2013, 8:42 a.m. ET
By Saabira Chaudhuri
Galectin Therapeutics Inc. (GALT) has received fast track designation for its treatment for fatty liver disease with advanced fibrosis from the U.S. Food and Drug Administration.
Fatty liver disease is characterized by the presence of fat in the liver along with inflammation and damage in people who drink little or no alcohol. Over time, patients with fatty liver disease can develop fibrosis, or scarring of the liver.
According to data cited by Galectin, about nine to 15 million people in the U.S. are affected by fatty liver disease.
Galectin, which develops therapeutics that target galectin proteins to treat fibrosis and cancer, has received the designation for GR-MD-O2, or galactoarabino-rhamnogalacturonate for nonalcoholic steatohepatitis with hepatic fibrosis.
Galectin is currently conducting a Phase 1 clinical trial to evaluate the safety, tolerability and exploratory biomarkers for efficacy for single and multiple doses of GR-MD-02 in treating patients with fatty liver disease with advanced fibrosis.
"Our preclinical data has shown that GR-MD-02 has robust treatment effects in reversing fibrosis and cirrhosis," Chief Executive Peter G. Traber said. "Fast Track designation enables us to expedite the compound's development and review process."
The FDA's fast track program is designed to expedite the review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.
Shares closed Friday at $5.57 and were inactive premarket. The stock has risen 30% in the past three months.
Write to Saabira Chaudhuri at saabira.chaudhuri@wsj.com
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