PARIS, June 27 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)