Tasly Pharmaceuticals (SHA: 600535), a China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its human fibroblast growth factor 21 injection, B1344, in patients with non-alcoholic steatohepatitis (NASH). This development marks a significant step in the exploration of novel treatments for NASH, a growing health concern globally.
B1344: A Promising Treatment for NASH and Type 2 Diabetes
B1344, classified as a Category 1 biologic, is under development for the treatment of both type 2 diabetes and NASH. It is a polyethylene glycol-based recombinant human fibroblast growth factor 21 mutant, designed to target the underlying metabolic issues associated with these conditions. Preclinical animal efficacy experiments have demonstrated B1344’s potential in significantly reducing the degree of liver steatosis, ballooning degeneration, and hepatic lobular inflammation in model animals.
Preclinical Results and Clinical Implications
The preclinical results are encouraging, showing that B1344 improved the activity score and fibrosis associated with non-alcoholic fatty liver disease. Additionally, the treatment reduced serum alanine aminotransferase (ALT) levels, a key biomarker for liver health. These findings suggest that B1344 may offer a promising therapeutic option for patients with NASH, potentially improving liver function and reducing the progression of liver disease.-Fineline Info & Tech
