Mont-Saint-Guibert, Belgium, April 12, 2018 – Promethera® Biosciences SA, a global innovator in cell-based medicines and liver diseases, today presented novel preclinical data on its development program HepaStem™. Building on previously generated data in early-stage Nonalcoholic steatohepatitis (NASH), the new data demonstrates for the first time the cell-based therapy’s ability to improve key disease parameters in a proven model for the advanced stage of the disease. NASH represents a severe form of nonalcoholic liver disease (NAFLD), one of the prominent liver diseases worldwide. The results were presented today at the European Association for the Study of the Liver (EASL) Annual Congress 2018, currently being held in Paris, France.
In the current study, the NASH STAM™ model for advanced stage NASH was used to evaluate the therapeutic effect of the liver-derived cell-based treatment HepaStem™. The data showed a significant and dose-dependent decrease in the commonly used NAFLD activity score (NAS) following one (22.4% NAS reduction) or three intravenous injections of HepaStem™ (32.6% NAS reduction versus the control arm). This effect was mainly attributed to a significant reduction in inflammation, thus supporting the proposed mechanism of action of HepaStem™.
“As Promethera® continues to pioneer the application of cell therapy for the treatment of chronic liver disorders, it is very encouraging to see that HepaStem™ was able to reduce established disease parameters in preclinical models for both early and now also advanced stages of NASH. Overall, the data we have generated so far in NASH in addition to the safety and tolerability data in pediatric patients with metabolic disorders justify the evaluation in additional phase I/II studies including also more severe NASH patients,” commented Etienne Sokal, MD, PhD, Chief Innovation and Scientific Officer of Promethera®.