The FDA has cleared Genfit’s IND application to treat a second liver disease with a big unmet clinical need. With this new step forward, the company gets even closer to become the leader in liver disease treatments.
After a very successful fundraising last week, Genfit is kicking off the week with good news from the FDA, which has given the thumbs up to start Phase II trials for Primary Biliary Cholangitis (PBC). The drug tested will be Elafibranor, Genfit’s lead candidate seeking to unlock the NASH market.
The good news is the cherry on top of an exceptional year for Genfit, which has initiated Phase III trials for NASH and announced the first non-invasive NASH diagnostic. Although the PBC market is much smaller than that for NASH, the company expects to benefit from the lack of effective alternatives in this new area.
Despite being a rare disease, PBC is one of the most common autoimmune diseases, affecting nearly 1 in 1,000 women over the age of 40.