Shares of one of the companies potentially close to having a therapy on the market for nonalcoholic steatohepatitis fell Friday after the firm said it would delay unblinding of data from its double-blind Phase III trial.
Lille, France-based Genfit said Thursday that it had delayed unblinding of data from the Phase III RESOLVE-IT study of elafibranor in NASH as it awaits comments from the Food and Drug Administration. The company expects to receive the agency’s feedback by the end of next month and plans to announce topline interim results from its study in the weeks thereafter.
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Genfit’s stock was down 3.7% on the Euronext Paris and Nasdaq markets following the news.
It’s not the first time Genfit has delayed the announcement of data from the trial. In September, the company delayed its readout for RESOLVE-IT from the end of 2019 to the first quarter of this year.
In a note to investors Friday, B. Riley FBR analyst Mayank Mamtani wrote that it was encouraging that the latest delay is not related to analysis of the trial’s primary endpoint, namely NASH resolution without worsening of fibrosis. However, he wrote, the delay means that data the company can use to seek FDA approval will not be disclosed until the second quarter of this year, and “a second delay doesn’t generally help the case in building investor confidence.”
If RESOLVE-IT shows positive results and leads to FDA approval, elafibranor would presumably hit the market next year.
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The delay relates to a meeting the company had in December with the FDA to discuss secondary endpoints in RESOLVE-IT that relate to measures like cholesterol, triglycerides and HbA1c blood sugar. Mamtani noted that companies developing NASH drugs, such as Madrigal Pharmaceuticals, are increasingly including such metabolic parameters into their clinical trial protocols.
NASH is a form of nonalcoholic fatty liver disease characterized by accumulation of fat in the liver, leading to inflammation and fibrosis that can ultimately lead to cirrhosis.
The company most likely to be the first to have a drug on the market for NASH is New York-based Intercept Pharmaceuticals, whose drug, obeticholic acid, is currently under FDA review.
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