(Adds company comment, background)
By Bill Berkrot and Ransdell Pierson
(Reuters) - French drugmaker Genfit SA said on Thursday it will begin a late stage trial later thisyear of its lead treatment for a liver-destroying condition,saying it failed a midstage trial in part due to its inclusionof many patients with a mild form of the disease.
The company said had it excluded data from those patientswith the mildest form of the disease known as NASH(non-alcoholic steatohepatitis) its drug, called GFT505, wouldhave been deemed effective in reversing the condition. Companyofficials said Genfit would likely include only more seriouslyill patients in its planned Phase III trials which will test1,500 to 2,000 patients.
Due to the unexpected rate of resolution of NASH in patientswho received a placebo and the large number of test sites withvery few patients, the trial did not reach its intended goal,the company said.
When adjusting for those factors, the results were "quiterobust for NASH," Dean Hum, the company's chief scientificofficer told Reuters in an interview.
GFT505 also demonstrated a favorable effect on metabolicfactors, lowering bad LDL cholesterol as well as unhealthy bloodfats called triglycerides and levels of blood glucose. NASH hasbeen closely associated with obesity and diabetes.
Heart disease remains the number one killer of NASH patientsand at least one rival experiential treatment, from InterceptPharmaceuticals, has caused concern because it hasraised LDL levels in trials.
"This trial confirms 505 is cardioprotective," Hum said."This is a clear differentiation between 505 and some othercompounds."
Shares of Intercept rose 10 percent after Thursday's mixedresults 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, includingGilead Sciences Inc and Conatus Pharmaceuticals, which earlier on Thursday said its experimental drug,emricasan, was more effective than a placebo in a mid-stagefatty liver disease study. Its shares jumped more than 26percent.
Analysts have said any effective treatment for NASH or thecomplications it causes, such as the scarring known as fibrosisand cirrhosis, could capture annual sales of $10 billion. (Reporting by Ransdell Pierson and Bill Berkrot; Editing byChris Reese and Marguerita Choy)
By Bill Berkrot and Ransdell Pierson
(Reuters) - French drugmaker Genfit SA said on Thursday it will begin a late stage trial later thisyear of its lead treatment for a liver-destroying condition,saying it failed a midstage trial in part due to its inclusionof many patients with a mild form of the disease.
The company said had it excluded data from those patientswith the mildest form of the disease known as NASH(non-alcoholic steatohepatitis) its drug, called GFT505, wouldhave been deemed effective in reversing the condition. Companyofficials said Genfit would likely include only more seriouslyill patients in its planned Phase III trials which will test1,500 to 2,000 patients.
Due to the unexpected rate of resolution of NASH in patientswho received a placebo and the large number of test sites withvery few patients, the trial did not reach its intended goal,the company said.
When adjusting for those factors, the results were "quiterobust for NASH," Dean Hum, the company's chief scientificofficer told Reuters in an interview.
GFT505 also demonstrated a favorable effect on metabolicfactors, lowering bad LDL cholesterol as well as unhealthy bloodfats called triglycerides and levels of blood glucose. NASH hasbeen closely associated with obesity and diabetes.
Heart disease remains the number one killer of NASH patientsand at least one rival experiential treatment, from InterceptPharmaceuticals, has caused concern because it hasraised LDL levels in trials.
"This trial confirms 505 is cardioprotective," Hum said."This is a clear differentiation between 505 and some othercompounds."
Shares of Intercept rose 10 percent after Thursday's mixedresults 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, includingGilead Sciences Inc and Conatus Pharmaceuticals, which earlier on Thursday said its experimental drug,emricasan, was more effective than a placebo in a mid-stagefatty liver disease study. Its shares jumped more than 26percent.
Analysts have said any effective treatment for NASH or thecomplications it causes, such as the scarring known as fibrosisand cirrhosis, could capture annual sales of $10 billion. (Reporting by Ransdell Pierson and Bill Berkrot; Editing byChris Reese and Marguerita Choy)
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