Olarofim Shows Non-Inferiority to AmBisome® in Invasive Aspergillosis Study

MANCHESTER, United Kingdom and OSAKA, Japan, Oct. 21, 2026 /CourierPR/ -- F2G Ltd and Shionogi & Co., Ltd have announced the results of a global Phase 3 OASIS study evaluating the investigational oral antifungal olorofim against AmBisome® followed by standard of care (AmBisome®+SOC) in patients with invasive aspergillosis. The study, which will be featured in a late-breaking oral presentation at IDWeek 2026 on October 22, 2026, showed that olorofim was non-inferior to AmBisome®+SOC, with a Day 42 all-cause mortality rate of 23.8% for olorofim versus 24.3% for AmBisome®+SOC.

The OASIS study randomized 225 patients, with 151 in the olorofim arm and 74 in the AmBisome®+SOC arm. The primary endpoint of the study, Day 42 all-cause mortality, met its non-inferiority margin within a pre-specified 20% margin. Specifically, the rate of all-cause mortality at Day 42 for olorofim was 23.8% (36/151) compared to 24.3% (18/74) for AmBisome®+SOC, with a difference of -0.5% and a 95% confidence interval (CI) of -13.1 to 10.8%.

The study also showed similar efficacy rates in key secondary endpoints. At Day 42, the Mycoses Study Group - European Organization for Research and Treatment of Cancer (MSG-EORTC) global response was 26.5% (40/151) for olorofim versus 31.1% (23/74) for AmBisome®+SOC. By Day 84, the global response rate was 30.5% (46/151) for olorofim and 28.4% (21/74) for AmBisome®+SOC.

The study also demonstrated that olorofim had a lower rate of drug-related adverse events. Only 35.8% (54/151) of patients in the olorofim arm experienced at least one drug-related adverse event, compared to 63.9% (46/72) in the AmBisome®+SOC arm. Furthermore, olorofim showed a lower rate of serious drug-related adverse events, with 4.0% (6/151) of patients experiencing such events, compared to 18.1% (13/72) in the AmBisome®+SOC arm.

Olorofim, a first-in-class antifungal with a novel mechanism of action, is the first such advance in over 20 years.

The results of the OASIS study build on previous Phase 2b data, which showed efficacy and good tolerability in patients with few or no treatment options for a range of invasive fungal diseases, including invasive aspergillosis.

Shionogi and F2G are collaborating to develop and commercialize olorofim, with Shionogi having commercial responsibility for olorofim in Europe and Asia, and F2G in North America and territories outside Shionogi’s regions. The company anticipates resubmitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) by the end of 2026.