Galactoarabino-rhamnogalacturonate: Additional Phase I data

Data from 9 NASH patients with advanced liver fibrosis in the second cohort of the double-blind, placebo-controlled, dose-escalation, U.S. Phase I GT-020 trial showed that infusions of 4 mg/kg IV GR-MD-02 on days 0, 21, 28 and 35 were well tolerated with no serious adverse events reported. On exploratory secondary endpoints evaluating serum biomarkers of fibrosis and inflammation, 4 mg/kg GR-MD-02 did not significantly reduce FibroTest scores, an indirect biomarker of fibrosis, vs. placebo. Additionally, 4 mg/kg GR-MD-02 did not significantly reduce Enhanced Liver Fibrosis (ELF) scores, a marker of fibrotic tissue turnover, which tended to increase with 4 mg/kg GR-MD-02 vs. placebo. Furthermore, 4 mg/kg GR-MD-02 did not significantly reduce levels of IL-6 or IL-8 vs. placebo.

In March, Galectin reported data from 8 patients in the first cohort showing that 2 mg/kg IV GR-MD-02 on days 0, 28, 35 and 42 did significantly reduce FibroTest scores (p=0.0442) and levels of IL-6 (p=0.0224) and IL-8 (p=0.0219) vs. placebo. The 2 mg/kg dose of GR-MD-02 non-significantly reduced ELF scores vs. placebo (p=0.2466) (see BioCentury, April 14). Galectin said serum biomarkers were evaluated at day 56 (14 days after the last infusion) in the first cohort (day 56) and at day 38 (3 days after the last infusion) in the second cohort and that differences in biomarker data between cohorts may potentially be due to sampling dates. ...