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. The new trial will study the safety and efficacy of the drug in patients for whom the standard ursodeoxycholic acid (UDCA) treatment has failed. Despite UDCA being the main therapy available, 70% of patients don’t respond or can’t tolerate it.
Genfit’s main rival is Intercept Pharmaceuticals, whose candidate Ocaliva is also in Phase III for NASH and was recently approved for PBC in combination with UDCA. Elafibranor will still have to prove that it’s as good or better than Ocaliva to compete in this new area.
Despite the fierce competition with Intercept, Genfit seems confident in keeping a strong leading position. In March, Jean-Francois Mouney, Genfit’s CEO, told the press that the company expects to take 50% of the NASH market. This is a huge objective given that the market is expected to grow to a whopping €18B by 2025. Elafibranor may then easily make it into the top 10 best-selling biologicals in a few years, with approval expected as early as 2022.
Genfit’s market predictions are clearly attracting investors, who recently backed an oversubscribed rights offering and a €50M fundraising for clinical trials. The company is decidedly on the right track to be the first to launch a NASH treatment and establish itself as a leader in liver disease with the addition of this new indication in its pipeline.
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