Shionogi and F2G report Phase 3 results for oral antifungal olorofim
Singapore, Oct. 22 -- Shionogi and F2G have reported detailed results from the global Phase 3 OASIS study evaluating investigational oral antifungal olorofim against AmBisome, followed by standard of care, in adults with invasive aspergillosis.
The randomised study enrolled 225 patients whose infections could not be treated appropriately with mould-active azole therapies or had failed to respond to them. Patients were allocated two to one to receive olorofim or the comparator regimen.
OASIS met its primary endpoint of non-inferiority for all-cause mortality at Day 42, using a prespecified margin of 20 percentage points. Mortality was 23.8% with olorofim and 24.3% with the comparator, a difference of -0.5 percentage points.
The companie...
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