The committee overseeing Genfit’s registration-directed Phase III trial testing its drug in a fatty-liver disease without any approved treatments has recommended that the trial move forward.
The Lille, France-based company said Tuesday that the data safety monitoring board for the Phase III RESOLVE-IT study of elafibranor in nonalcoholic steatohepatitis (NASH) recommended that it continue without any modifications, supporting that the drug is generally safe and well-tolerated. The recommendation was the seventh in which the DSMB recommended that the study continue without any modification or discontinuation, based on a review of safety data, including for patients who have received the drug for as long as three years.
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Shares of Genfit were up 8.3% on the Euronext Paris exchange and 3.5% on the Nasdaq following the news.
The company plans to announce top-line interim results for the study in the first quarter of next year and will file for Food and Drug Administration and European Medicines Agency approval by the end of 2020 if they are positive. If approved, elafibranor would be the first drug to win approval for resolution of NASH without worsening of fibrosis.
“This seventh, favorable DSMB review is further confirmation that our RESOLVE-IT trial can continue without modification, keeping us on track for an NDA filing by the end of 2020,” said Genfit Chief Medical Officer Carol Addy in a statement, referring to a New Drug Application, used to seek FDA approval for pharmaceutical drugs. “It strengthens our confidence that elavibranor is generally safe and well-tolerated, which is paramount for drugs that are intended to treat a chronic and silent disease such as NASH.”
In a note to investors Tuesday, B. Riley FBR analyst Mayank Mamtani wrote that Genfit’s announcement bodes favorably for the RESOLVE-IT readout.
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The news comes a day after another company, New York-based Intercept Pharmaceuticals, said the FDA had accepted and granted priority review to its application for the drug obeticholic acid for the treatment of liver fibrosis due to NASH. The company is seeking accelerated approval based on interim results of the Phase III REGENERATE study, announced earlier this year. By Tuesday afternoon, shares of the company had risen 14.3 percent over their Friday closing price.
NASH is a severe form of nonalcoholic fatty liver disease, or NAFLD, and accounts for 20% of the 25% adults estimated to have have NAFLD, according to the American Liver Foundation. NASH is distinguished from NAFLD in that it includes swelling or inflammation of the liver that can lead to fibrosis, which itself can progress to cirrhosis.
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