March 27, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Loos, France-based Genfit , whose U.S. headquarters are in Cambridge, Mass., announced yesterday that after massaging the data in a recent clinical trial, it hopes to continue with a late-stage trial later this year.
took a beating on the news. Shares were selling on Feb. 20, 2015 at a high of $69.09, and had been on a bit of a slow downward slide anyway, dropped from $50.85 on March 26, 2015 to a current price of $31.87.
The company announced topline results of its Phase II Golden-505 trial for non-alcoholic steatohepatitis (NASH) for its drug GFT505. Original data failed to meet the endpoints due to several factors. First, an unexpectedly high number of patients receiving placebo received “resolution of NASH.” Second, a high number of test sites had very few patients. Third, after analyzing the data, the company excluded data from patients who had the mildest form of NASH, because it skewed the data in too positive a fashion.
The results of the study were “quite robust for NASH,” after adjusting for those factors, said Dean Hum, Genfit’s chief scientific officer, in a statement.
The compound did show positive cardiovascular and metabolic effects, including lowering LDL cholesterol, the so-called “bad” cholesterol, as well as reducing triglycerides and blood glucose levels. “This trial confirms 505 is cardioprotective,” Hum said in a statement. “This is a clear differentiation between 505 and some other compounds.”
The company’s conclusion of the trial was “GFT505 120mg meets the primary endpoint: Reversal on NASH without worsening of fibrosis…” As a result, Genfit plans to present the data to the U.S. Food and Drug Administration (FDA) and Europe’s European Medicines Agency (EMA) in hopes of proceeding to a Phase III clinical trial.
There are no current treatments for NASH, which can cause fibrosis and cirrhosis. Analyst predict that if a company could develop a treatment, annual sales could hit $10 billion. Other companies working on treatments for NASH include Gilead Sciences, Inc. Intercept Pharmaceuticals and Conatus Pharma.
Analysts express concern about how the results will affect the company’s efforts, despite the conclusion Genfit makes after manipulating the data. “It will be difficult for Genfit to negotiate a partnership with a pharmaceutical company over the next six months,” said Arnaud Guerin, an analyst at Portzamparc Societe de Bourse SA in Nantes, France in a statement.
Michael Yee, an analyst with RBC Capital Markets, noted in a statement that he wasn’t sure he completely understood what Genfit meant after their data manipulation, but said, “anything that is positive only after slicing the data in different ways is not usually that good. However, the good news for Genfit may be the benign safety, at least according to limited data in the press release.”
It seems unlikely the data will expedite Phase III approval, but the company may be focusing on the cardiovascular and metabolic effects tied to fewer adverse side effects to push the drug into the next stage of evaluation.
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