Galmed: NASH trial shows improvements

 

• Histological improvement in fibrosis (≥1 stage) was demonstrated in 39% of subjects according to NASH CRN, in 61% of subjects by ranked assessment with a highly statistically significant (p<0.0001) reduction in fibrosis score demonstrated using AI-assisted, digital pathology reading

• Highly statistically significant (p<0.0001) reduction in liver stiffness by Fibroscan

• 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 is submitting all data to the FDA to initiate 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.

https://finance.yahoo.com/news/galmed-reports-results-open-label-130000557.html