pharmafileDecember 07, 2017
Tag: NASH , Galectin Therapeutics
Galectin Therapeutics has seen its share value almost halve after its revealed that GR-MD-02, its experimental treatment for non-alcoholic steatohepatitis (NASH) cirrhosis, had missed its primary endpoint in a Phase 2b trial.
Specifically, while the galectin-3 inhibitor showed a positive trend in changing hepatic venous pressure gradients (HVPG) in patients, it failed to demonstrate this to a clinically significant degree. It was found that 44% of patients without oesophageal varices in the lower of the two dose groups examined showed a reduction of at least 2 mmHg versus baseline, while 15% showed the same improvement in the placebo group. Additionally, 40% in the low dose group demonstrated an at least 20% decline in HVPG from baseline, while 15% saw the same response in the placebo group.
However, despite the disappointing trial results, Galectin noted that could have clinical potential in NASH cirrhosis patients without oesophageal varices – a group which accounted for 50% of the 162 trial participants.
Galectin CEO Peter Traber commented: "We believe that the results stratify a large and easily identifiable group of patients," while Dr Stephen Harrison, one of trial's lead investigators, added: "A therapy such as GR-MD-02 that could improve portal hypertension and potentially prevent the development of oesophageal varices in NASH cirrhosis and subsequent complications would be clinically valuable."
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