Genfit has told investors that it does not expect the COVID-19 pandemic to “significantly delay” the unblinding of its phase 3 nonalcoholic steatohepatitis (NASH) data. The database was locked at the end of February but will only be unblinded after the FDA has provided feedback.
France’s Genfit disclosed the need to wait on FDA feedback before taking a look at the phase 3 data last month, triggering a drop in its stock price. At that time, Genfit said it was delaying the unblinding “to incorporate the latest FDA insights expected by the end of March.” With March now almost over, Genfit has provided an update on the situation.
In the latest update, Genfit said that it does not “currently anticipate that the COVID-19 situation will significantly delay receipt of this feedback.” FierceBiotech is awaiting clarification from Genfit, but the comment, and timing of its release, suggests the feedback will be later than originally expected.
How much later has implications for Genfit’s efforts to bring elafibranor to market in NASH. Genfit thinks the results from the 1,000 or so patients in the locked database will support FDA approval, but that will remain uncertain until the feedback is shared and the data are unblinded and analyzed.
Intercept Pharmaceuticals, the one company Genfit is trailing in the NASH race, has also faced some COVID-19 disruption, with the FDA delaying an advisory committee meeting to discuss its filing from April to June. Intercept has a PDUFA action date of June 26.
While Genfit thinks COVID-19 is unlikely to significantly set back the unblinding of its data, other parts of its operation face more disruption. Genfit has paused all phase 1 trials of elafibranor. The studies “are necessary to support the elafibranor NDA submission for NASH,” Genfit said. Genfit has also paused enrollment in a phase 2 liver fat study and put the initiation of a phase 2 NASH combination trial and a phase 3 primary biliary cholangitis (PBC) program on hold.
In the face of the disruption, Genfit is trying to ensure its studies can hit the ground running when the pandemic subsides. Work toward the phase 2 combination trial and phase 3 PBC study is ongoing, and “all supporting activities pertaining to continuation of ongoing studies or the initiation of new studies will continue.”