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Shionogi & F2G have reported data from the global, adjudicator-blinded P-III (OASIS) trial evaluating oral olorofim (150mg, BID on Day 1, then 90mg, BID; up to 84 days) vs IV AmBisome (3mg/kg, QD) followed by SoC in adults (N=225; 2:1) with invasive aspergillosis for whom mould-active azole therapy was inappropriate or ineffective; data will be featured as a late-breaking oral presentation at IDWeek 2026 on Oct 22, 2026
The trial met its 1EP of non-inferiority (20% margin), with Day 42 all-cause mortality (ACM) of 23.8% vs 24.3% (difference: -0.5%); Day 84 ACM was 32.5% vs 29.7%, & MSG-EORTC global response was 26.5% vs 31.1% at Day 42 & 30.5% vs 28.4% at Day 84; olorofim-treated pts were discharged earlier (17 vs 28 days)
Drug-related AEs occurred in 35.8% vs 63.9% of pts (serious: 4.0% vs 18.1%), driven by fewer drug-related renal AEs (1.3% vs 22.2%), while DILI events were similar (4.6% vs 4.2%); F2G plans to resubmit an NDA to the US FDA by the end of 2026, while Shionogi will submit in Europe & Asia; olorofim is a first-in-class oral orotomide antifungal
Ref: Shionogi | Image: Shionogi & F2G | Press Release
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The post Shionogi and F2G Report P-III (OASIS) Trial Data of Olorofim for Invasive Aspergillosis appeared first on PharmaShots.
