HepaStem® as potential treatment for ACLF
HepaStem® is Promethera®’s lead cell therapy product currently in Phase 2 clinical trials for ACLF.
It consists of human allogeneic liver-derived medicinal signaling cells that are obtained from healthy, ethically donated organs and expanded in the manufacturing GMP factory.
HepaStem® is administered as a simple peripheral intravenous infusion, after which it is transported via the bloodstream to the liver, where it is expected to act as a cargo and activate 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 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 ACLF, represents an important unmet need. Therefore, Promethera® 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).
The first set of safety and tolerability results at 3 months of the Phase II (HEP101) clinical trial evaluating HepaStem®, the most advanced stem cell-based therapy of Promethera® and the first of its kind, has been published in JHEP Reports in 2021, the official open access journal of the European Association for the Study of the Liver (EASL). This peer-reviewed publication comes as recognition of the breakthrough treatment potential of HepaStem® for severe liver diseases.