Iqirvo failed as a treatment for the fatty liver disease MASH, but the drug is now FDA approved in primary biliary cholangitis. An Intercept Pharmaceuticals drug already treats this rare liver disease and Gilead Sciences is poised to compete with its PBC drug approaching an FDA decision this summer.
Liver disease remains the focus of Genfit, despite a high-profile clinical trial failure in the fatty liver disease NASH. The company is building out its pipeline by acquiring Versantis, a clinical-stage biotech whose most advanced drug candidate brings a novel approach to treating a deadly chronic liver disease complication that has no FDA-approved therapies.
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Ipsen is paying €120 million up front to acquire global rights to elafibranor, a Genfit drug that fell short as a treatment for NASH, but is currently in Phase 3 testing in another liver disease, primary biliary cholangitis. Meanwhile, Genfit is adding an early-stage drug candidate to its own pipeline via a separate transaction.
The company said it was formally terminating the Phase III study of the drug elafibranor in NASH and refocus its development of the drug on another disease, primary biliary cholangitis, as well as a diagnostic for NASH.
The French drugmaker said Monday that its Phase III study of elafibranor failed to meet its primary and key secondary endpoints. Analysts remarked that this extends the lead of the drug likely to get the first NASH approval, Intercept's obeticholic acid.
Shares of the French company fell more than 3% Friday following news it would delay unblinding data from the Phase III study of elafibranor. This marks the second delay of data since September and means it will likely be announced in the second quarter rather than the first.
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These are four companies that currently have drugs in Phase III development for nonalcoholic steatohepatitis or have them under Food and Drug Administration review.
In an interview at the BIO CEO & Investor Conference in New York Monday, CEO Pascal Prigent said barriers to access rather than reimbursement represent the biggest concern for NASH drugs like elafibranor. As a ballpark estimate, a list price in the $10,000 range is possible.
In a note to investors, an analyst wrote that the news bodes well for the company's anticipated Phase III readout for the drug, elafibranor. Another company, Intercept Pharmaceuticals, said the FDA had accepted its application for its investigational NASH drug, obeticholic acid.
The French company, developing a drug to treat nonalcoholic steatohepatitis, or NASH, announced the pricing of its shares at $20.32 apiece.
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The company, one of several developing drugs for the growing fatty liver disease, said in an SEC filing that it would sell its shares at $26.33 apiece.
From clinical trial saturation to a suspiciously strong placebo effect: Here are some of the major challenges facing biopharma companies in pursuit of the first FDA-approved therapy for non-alcoholic steatohepatitis (NASH).