PARIS, June 27 Fri Jun 27, 2014 11:56am EDT
PARIS, June 27 (Reuters) - Genfit said regulators had ruled the French biotech company could pursue a mid-stage Phase 2b clinical study on its daily oral drug candidate for treating non-alcoholic steatohepatitis, or NASH, a condition that damages the liver.
The independent Data and Safety Monitoring Board (DSMB) recommended continuing the trial on diabetic and non-diabetic patients in Europe and the United States, after reviewing data collected so far, Genfit said in a statement on Friday.
"The DSMB does not raise any safety concern which might jeopardize the security of the patients and provides its unrestricted approval to continue the Phase 2b clinical trial in NASH," Genfit said.
Genfit launched the trial of the drug, known as GFT505, for treating NASH in September 2012 after obtaining Food and Drug Administration (FDA) approval to perform the study in the United States. First data on the drug's effectiveness should be available in mid-January 2015, Genfit said. (Reporting by James Regan; Editing by David Holmes)
PARIS, June 27 (Reuters) - Genfit said regulators had ruled the French biotech company could pursue a mid-stage Phase 2b clinical study on its daily oral drug candidate for treating non-alcoholic steatohepatitis, or NASH, a condition that damages the liver.
The independent Data and Safety Monitoring Board (DSMB) recommended continuing the trial on diabetic and non-diabetic patients in Europe and the United States, after reviewing data collected so far, Genfit said in a statement on Friday.
"The DSMB does not raise any safety concern which might jeopardize the security of the patients and provides its unrestricted approval to continue the Phase 2b clinical trial in NASH," Genfit said.
Genfit launched the trial of the drug, known as GFT505, for treating NASH in September 2012 after obtaining Food and Drug Administration (FDA) approval to perform the study in the United States. First data on the drug's effectiveness should be available in mid-January 2015, Genfit said. (Reporting by James Regan; Editing by David Holmes)
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