Galectin Therapeutics Inc (NASDAQ:GALT) reported that its Phase 2b NASH-CX study of GR-MD-02 demonstrated statistically notable and clinically meaningful data in lowering the primary endpoint measurement of hepatic venous pressure gradient against placebo in NASH cirrhosis subjects without esophageal varices, which showcased 50% of the patients registered in the clinical study.
Galectin noted a promising trend in the total group of people, with as well as without varices, however the difference did not meet statistical significance for this main endpoint as there was more inconsistency in HVPG measurements for people with esophageal varices. For the key secondary endpoint review of liver biopsy, assessment of the total study population of 161 patients demonstrated a statistically notable effect of drug treatment for enhancing hepatocyte ballooning, which is a major factor in the underlying ailment course in NASH.
Significantly, assessment of the secondary endpoint of problems of cirrhosis demonstrated there was a statistically significant decline in the advancement of new esophageal varices in people without varices at baseline. The company also performed a rigorous evaluation of the response to therapy by assessing the percent of subjects who recorded a reduction of hepatic venous pressure gradient from baseline. Responders were stated as having reductions of hepatic venous pressure gradient from baseline that have been demonstrated to be clinically notable.
Dr. Peter G. Traber, M.D., the CMO and CEO of Galectin Therapeutics, expressed that they consider this is the initial large, randomized clinical study of any medication to showcase a clinically meaningful enhancement in liver biopsy or portal hypertension in people with NASH cirrhosis without varices. Furthermore, they consider that the results stratify an easily and large identifiable group of subjects. The results also indicate numerous potential registration objectives that may be used in a Phase III plan, including percent or absolute changes in HVPG, the percentage of people who respond with a clinically pertinent decline in HVPG, and the advancement of esophageal varices.