Prometheus BioScience Inc. Provides Update On Hepastem NASH-Fibrosis Program With Late-Breaking Preclinical Data At 2016 American Association for Study of Liver Diseases Meeting

--HepaStem reduces liver inflammation and improves fibrosis symptoms in a NASH mouse model--

MONT-SAINT-GUIBERT, Belgium--(BUSINESS WIRE)--Promethera Biosciences SA, a world-leading cell therapy and regenerative medicine company targeting liver diseases, today announced the presentation of new preclinical NASH-Fibrosis data from its proprietary HepaStem program, demonstrating a beneficial effect of HepaStem in a nonalcoholic steatohepatitis (NASH) mouse model and confirming Hepastem’s unique and multifaceted mode of action. The results were presented on Sunday, November 13th by the Promethera R&D and Medical Affairs team, in a late-breaking poster presentation titled, “Clinical-grade human liver mesenchymal stem cells for the treatment of NASH-Fibrosis through immunomodulation” at The Liver Meeting® 2016, the 67th Annual Meeting of the American Association for the Study of Liver Disease (AASLD), currently being held in Boston, Massachusetts.

“These first data support that HepaStem has the strong potential to modulate and decrease inflammation and fibrosis, opening the route to promising clinical trials in NASH and other severe inflammatory conditions of the liver”

In the study, HepaStem was administered in a single and repeated dose setting with or without immunosuppression in a NASH STAMTM cell mouse model. HepaStem significantly reduced inflammation and Nonalcoholic Fatty Liver Diseases (NAFLD) Activity score (NAS), as well as fibrotic collagen deposition in liver sections at 9 weeks of age. In addition, Promethera’s in-house R&D could further elucidate the underlying immunomodulatory effect of HepaStem cells. In in vitro co-culturing systems with T-lymphocytes or dendritic cells, HepaStem was shown to decrease T-cell activation and dendridic cell generation and activation in vitro. HepaStem cells were also shown to secrete high levels of HGF (Hepatocyte Growth Factor), a growth factor known to inhibit stellate cells, the key in-situ players in liver fibrosis development.

“These first data support that HepaStem has the strong potential to modulate and decrease inflammation and fibrosis, opening the route to promising clinical trials in NASH and other severe inflammatory conditions of the liver,” said Prof. Dr. Etienne Sokal, Founder and CI and CSO of Promethera Biosciences. He added that Promethera is further investigating preclinical studies in various liver inflammatory and fibrotic models.

“Promethera is in the process of building on results such as these that firmly support our expansion to the larger indications of NASH, liver inflammation and fibrosis,” said Dr. John Tchelingerian, CEO of Promethera Biosciences. “With the good safety profile shown in the pediatric patients from our initial clinical studies, HepaStem cells offer a unique product profile which we believe will differentiate Promethera’s approach as a novel and impactful cell therapy platform in a highly-competitive environment as our industry seeks therapies for devastating liver diseases.”

HepaStem is a cell suspension constituted of heterologous human adult liver-derived mesenchymal stem cells isolated from ethically donated healthy adult human liver tissue. HepaStem treatment has been shown to be safe in a phase I/II study in 20 pediatric patients suffering from inherited metabolic disorders.

About Promethera Biosciences

Promethera Biosciences is a clinical stage biopharmaceutical company and the global leader in cell therapy and regenerative medicine for the treatment of inborn and acquired liver diseases with no effective therapeutic cure. Promethera uses allogeneic progenitor cells, stem cells and mature hepatocytes that are harvested and purified from non-transplantable, healthy human livers (Heterologous Human Adult Liver-derived Progenitor Cells, HHALPC and Heterologous Human Liver Cells, HHLivC). These technologies have resulted in the development of three different cell products, HepaStem and H2Stem (progenitor/stem cells) and Heparesc® (mature hepatocytes). Promethera specializes in the development of therapeutic options for the treatment of a broad variety of liver diseases. These range from orphan indications, such as rare inborn metabolic diseases including urea cycle disorders (UCD) to large indications such as acute-on-chronic liver failure (ACLF), and nonalcoholic steatohepatits (NASH)/fibrosis.

Promethera Biosciences is a spin-off of the Walloon Region-based Université catholique de Louvain (UCL) and was founded in 2009 by Prof. Dr. Etienne Sokal and Sopartec, the tech transfer office (TTO) of UCL. Promethera is headquartered in Mont-Saint-Guibert, Belgium with a U.S. based operation and a GMP compliant manufacturing facility in Durham, NC, US. For more information, visit


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