Genfit to conduct large liver drug trial despite setback

Reuters Health Information: Genfit to conduct large liver drug trial despite setback

Genfit to conduct large liver drug trial despite setback

Last Updated: 2015-03-26

By Bill Berkrot and Ransdell Pierson

(Reuters) - French drugmaker Genfit SA said on Thursday it will begin a late stage trial later this year of its lead treatment for a liver-destroying condition, saying it failed a midstage trial in part due to its inclusion of many patients with a mild form of the disease.

The company said had it excluded data from those patients with the mildest form of the disease known as NASH (non-alcoholic steatohepatitis) its drug, called GFT505, would have been deemed effective in reversing the condition.

Company officials said Genfit would likely include only more seriously ill patients in its planned Phase III trials which will test 1,500 to 2,000 patients.

Due to the unexpected rate of resolution of NASH in patients who received a placebo and the large number of test sites with very few patients, the trial did not reach its intended goal, the company said.

When adjusting for those factors, the results were "quite robust for NASH," Dean Hum, the company's chief scientific officer told Reuters in an interview.

GFT505 also demonstrated a favorable effect on metabolic factors, lowering LDL cholesterol as well as triglycerides and levels of blood glucose. NASH has been closely associated with obesity and diabetes.

Heart disease remains the number one killer of NASH patients and at least one rival experiential treatment, from Intercept Pharmaceuticals, has caused concern because it has raised LDL levels in trials.

"This trial confirms 505 is cardioprotective," Hum said. "This is a clear differentiation between 505 and some other compounds."

Shares of Intercept rose 10% after Thursday's mixed results for the rival Genfit drug.

There are currently no approved treatments for NASH, which affects millions of people, primarily in developed nations.

Several companies are pursuing NASH treatments, including Gilead Sciences Inc and Conatus Pharmaceuticals, which earlier on Thursday said its experimental drug, emricasan, was more effective than a placebo in a mid-stage fatty liver disease study. Its shares jumped more than 26%.

Analysts have said any effective treatment for NASH or the complications it causes, such as fibrosis and cirrhosis, could capture annual sales of $10 billion.

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