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TheraNASH program

TheraNASH is a University of Strasbourg start-up in foundation that strives to become a key player in the discovery and preclinical development of novel therapeutic strategies for liver fibrosis and non-alcoholic steatohepatitis (NASH), diseases with major global health impact. Liver disease is the only major cause of death still increasing each year. The absence of effective therapeutic options for NASH leaves open an untapped market which is likely worth 5 B$ to 10 B$ a year. TheraNASH offers state-of-the-art technologies for fast-track drug discovery and novel therapeutic strategies for liver fibrosis and NASH.

TheraNASH has developed a unique approach that targets the clinical cell circuits underlying liver disease progression and carcinogenesis and that has predictive value for disease progression and NASH. TheraNASH’s discovery platform features a tractable and clinically relevant human cell-based model system inducing a clinical liver disease progression signature in a reversible manner. The power of the TheraNASH drug discovery platform is highlighted by the identification of molecules with established anti-fibrotic activity.

Using this technology TheraNASH has discovered a lead candidate compound for NASH, a humanized monoclonal antibody (mAb) targeting human tight junction protein CLDN1 (PCT/EP2016/055942; PCT/EP2017/056703). The CLDN1 mAb reverses liver disease and steatosis without detectable adverse effects in state-of-the-art animal models for liver disease progression. Mechanistic analyses reveals that the antibody modulates the expression and activation of key pathways involved in pathogenesis of liver inflammation and fibrosis. We expect that this antibody is a first or best-in-class compound for treatment of NASH given the in vivo and ex vivo proof-of-concept data combined with its unique mechanism of action. TheraNASH aims to deliver a pre-IND high quality package for a first in humans Phase I safety profile clinical trial in 2019.

TheraNASH’s innovative developments promise to define new therapeutic standards in liver disease progression and prevention of liver cancer. Importantly, the innovation of TheraNASH is well protected through a strong IP platform originating from Prof. Baumert’s research programs at Inserm and the University of Strasbourg. This patent portfolio covers the liver therapeutics discovery technology, as well as TheraNASH’s lead compound, the monoclonal antibody against claudin-1, for the treatment of steatosis, fibrosis and NASH and the prevention of liver disease progression and cancer.

The associated research within University of Strasbourg is funded through the EU (ERC, H2020) as well as Strasbourg’s technology transfer initiative (SATT Conectus Alsace).