As NASH Race Heats up, Genfit Announces $100 Million IPO
Genfit is a late-stage biopharma company focused on developing therapeutics for metabolic and liver diseases. The area that has the most interest is nonalcoholic steatohepatitis or NASH. NASH is similar to cirrhosis of the liver but occurs in patients who drink little or no alcohol. It is a multifactorial disease, involving fibrosis, inflammation and fatty liver. It is associated with high cholesterol, obesity and type 2 diabetes.
At this time, there is no specific treatment for NASH except for lifestyle changes and various medications for the associated diseases. Genfit is one of several companies in a race to get a product on the market for the disease, including Allergan, Intercept, Shire, Novo Nordisk, Novartis, Galmed and Conatus.
Genfit’s lead compound is elafibranor. It is currently in the RESOLVE-IT Phase III clinical trial evaluating the drug in NASH.
In December 2018, the company announced positive results from its Phase II trial of the drug in patients with related chronic liver disease, primary biliary cholangitis. The primary endpoint of that study was changed at week 12 in serum alkaline phosphatase (ALP) from baseline. That endpoint was met in both doses. It also met a key secondary endpoint, a composite endpoint of serum ALP, an ALP decrease and total bilirubin. The company stated at the time, “On this endpoint, elafibranor achieved the substantially higher response rates of 67 percent for 80 mg and 79 percent for 120 mg as compared to 6.7 percent for placebo.”
On February 2, the company released its 2018 full-year financial report. Its cash position was 207.2 million euros.
“The lead programs in our clinical and diagnostic pipeline, in particular, the later-stage ones in NASH and PBC, have moved forward considerably and met our corporate 2018 milestones,” stated Jean-Francois Mouney, chairman and chief executive officer of Genfit. “We completed enrollment for the interim analysis cohort of our Phase III RESOLVE-IT trial of elafibranor in NASH, achieved positive results in the Phase II trial of elafibranor in PBC and accomplished significant milestones in the regulatory and commercial development of our biomarker program, leading to the signature of a licensing agreement with LabCorp in early January this year.”
Because NASH has so many similarities to other common disorders, it often is undiagnosed. Because of this, Genfit has worked to develop a liver diagnostic test. LabCorp is currently the largest clinical diagnostic laboratory company in the U.S., and possibly the world.
Genfit developed a novel, non-invasive test specifically for NASH using a blood sample. On January 3, it signed the licensing deal with LabCorp, headquartered in Burlington, NC. The deal is with LabCorp’s Covance drug development business.
“LabCorp and Covance will be able to leverage our experience in clinical trial biomarkers and diagnostics development to validate the NIS4 algorithm,” stated Marcia Eisenberg, LabCorp Diagnostics’ chief scientific officer. “We are well-positioned to expand access to NIS4 to the global clinical research community through this agreement. Forward-thinking collaborations like this one enable early and efficient validation of diagnostics that have the potential to significantly impact patients with serious, life-changing unmet medical needs, including NASH.”