F2G and Shionogi report positive Phase 3 results for oral antifungal olorofim in invasive aspergillosis

Product / Tech Impact 4
โดย GlobeNewswire·Read original
Summary · why it matters

F2G and Shionogi announced that the global Phase 3 OASIS study of the investigational oral antifungal olorofim met its primary endpoint of non-inferiority against AmBisome followed by standard of care in patients with invasive aspergillosis refractory to or unsuitable for azole therapy. The all-cause mortality rate at Day 42 was 23.8% for olorofim and 24.3% for the comparator arm, a difference of -0.5 percentage points with a 95% confidence interval of -13.1 to 10.8%. Drug-related treatment-emergent adverse events occurred in 35.8% of olorofim patients versus 63.9% in the AmBisome arm, with the difference mainly driven by a higher rate of renal events in the comparator group. If approved, olorofim would be the first novel mechanism agent for invasive aspergillosis in more than 20 years. F2G and Shionogi plan to submit the data to regulators, with F2G responsible for the U.S. and Shionogi for Europe and Asia.

Impact on stocks 1

Biotech & Genomic Medicine · 1 stocks
Shionogi & Co., Ltd.
4507
▲ PositiveTechnologyrelevance

Positive Phase 3 results for olorofim, a novel antifungal, with Shionogi responsible for European and Asian commercialization.

Theme Impact 1

Off-coverage companies 1

F2G LtdPrivate▲ Positive
Technologyrelevance

F2G's investigational oral antifungal olorofim met primary endpoint in Phase 3 study, supporting regulatory submission in the U.S.

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