Genfit Gets Ready to Launch Drug for Untreated Liver Disease Raising €120M

After some big failures from its top competitors earlier this year, French company Genfit has done an IPO to prepare the launch of its drug for NASH, a chronic liver disease for which there is currently no treatment.

Today, Genfit has started trading on Nasdaq. Together with issuing new shares in its existing Euronext Paris listing, the French company has raised a total of €120M ($135M).

A big chunk of this money — €44.3M — will be invested in completing a phase III trial testing Genfit’s core drug, called elafibranor, as a treatment for non-alcoholic steatohepatitis (NASH). Results from the trial are expected by the end of the year, and the company is also setting aside €13.3M to prepare for the commercialization of the drug.

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NASH, also known as the ‘silent liver disease,’ is caused by the buildup of fat in the liver, often as a consequence of obesity and diabetes. The condition affects 12% of the population and is soon expected to replace hepatitis C as the primary reason behind a liver transplant.  

2019 has not been a good year for the NASH field so far. Both Gilead and Novartis reported the failure of clinical trials for their NASH drugs. US-based Intercept Pharmaceuticals did have seemingly positive results in a phase III trial, but a closer inspection reveals that the lower dose doesn’t work and the one that does work comes with worryingly high toxicity for the patients.

Although Intercept is nevertheless planning to file for approval by the end of the year, Genfit could have a significant advantage over its US rival — if the results of its ongoing phase III study are good enough.

In earlier stages of development, there are companies testing multiple approaches against NASH. Examples include a cell therapy from Promethera, an immunotherapy from Tiziana Life Sciences, and an RNA treatment from MiNA Therapeutics.  

Genfit is aiming to differentiate itself from most of its competitors with the development of a new kind of diagnostic test for NASH. Unlike current diagnostics, Genfit is working on a test that is non-invasive and that can distinguish between different stages of the disease. The company has stated that €5.3M of the funds will be directed to obtain approval and commercialize this test.

Genfit will also be spending €31M in a phase III trial testing elafibranor in a rarer liver disease known as primary biliary cholangitis, as well as €5.3M to research drug combinations of elafibranor. 

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