GLMD - Galmed rises 17% on positive data from NASH treatment trial
- Galmed Pharma ( NASDAQ: GLMD ) announced positive data from a Phase 3 study showing improvements in histology, imaging, and biomarkers with its therapy, Aramchol, to treat NASH and liver fibrosis.
- ( GLMD ) has risen ~17% .
- The study showed histological improvement in fibrosis in 39% of subjects according to Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN). About 60% of subjects showed highly statistically significant reduction in fibrosis score demonstrated using AI-assisted, digital pathology reading.
- The study also showed:
- Highly statistically significant (p<0.0001) reduction in liver stiffness.
- Highly statistically significant (p<0.0001) reduction in biochemical markers of liver injury ALT and AST.
- Highly statistically significant reductions in major fibrosis biomarkers: FIB-4 (p<0.0001), Pro-C3 (p<0.0001) and ELF (p= 0.0038) at week 24.
- Galmed plan to submit all data to the FDA to begin discussions on incorporating more sensitive histology reading methodologies as primary endpoints in NASH clinical studies and is actively looking for partnering opportunities to continue Aramchol's clinical development, it said.
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Galmed rises 17% on positive data from NASH treatment trial