HepaStem™ is Promethera’s lead cell therapy product currently in Phase 2 clinical trials for both NASH and ACLF.
It consists of human allogeneic liver-derived progenitor cells (HALPC) that are obtained from healthy, ethically donated organs and expanded in the manufacturing lab.
HepaStem™ can be administered intravenously, after which it is transported via the bloodstream to the liver, where it is expected to target multiple key pathogenetic pathways. Preclinical and clinical findings suggest that HepaStem™ enhances the liver’s own repair and regeneration processes by reducing inflammation as well as fibrogenesis thanks to its ability to inhibit hepatic stellate cell activation and collagen secretion, and even to degrade excessive extracellular matrix.
Liver diseases in general, NASH and ACLF in particular, constitute the next global epidemic, with lifestyle factors in the developing world being a major contributory factor.
The current lack of effective or curative drug therapies on the market, particularly for decompensated cirrhosis in late-stage NASH and ACLF, represents an important unmet need. Therefore, Promethera® Biosciences and our expert steering committee believe that HepaStem™ has excellent potential to make a significant impact on this market. The first clinical data in patients with ACLF have been presented at different scientific forums, such as the International Liver Congress (EASL 2019) and the American Association for the Study of Liver Diseases (AASLD 2019).