Positive phase III results for elafibranor in NASH are expected later this year, and the company wants an experienced marketer in charge going forward.
Genfit focuses on the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver-related diseases. Its lead candidate elafibranor (GFT505) is a medication for non-alcoholic steatohepatitis (NASH), a degenerative liver disease with limited treatment options. The drug demonstrated therapeutic efficacy in a phase IIb study in NASH and is currently being evaluated in the RESOLVE-IT phase III study. A readout of the results for the trial is expected later in 2019.
The company anticipates positive results from the latest study and expects to file for marketing approval for elafibranor in the not-too-distant future.
As Genfit moves through the later stages of development and commercialization, it will have a new CEO. Co-founder Jean-François Mouney, who has been the firm’s CEO, is stepping down. Executive Vice President of Marketing and Commercial Development Pascal Prigent, who has experience on the marketing side, will be taking his place. Mouney will remain Chairman of the company. Prigent, who previously served as VP of Marketing for GlaxoSmithKline’s vaccines division, joined Genfit in May 2019.
There was initially some confusion regarding Mouney’s departure being announced just before the reporting of the NASH study results, with concerns being raised about the possibility that the results were not positive. The confusion has been largely dissipated in response to the company’s explanation for Prigent’s promotion, which is intended to facilitate the advance of elafibranor to and beyond commercialization.
Elafibranor is also being developed as a treatment for primary biliary cholangitis (PBC), an autoimmune disease of the liver. In a phase II study, it was shown that two different doses of elafibranor resulted in 67% and 79% responses rates against the composite endpoint used in the trial for currently marketed drug Ocaliva (obeticholic acid, Intercept Pharmaceuticals), which elicited a 47% response rate.