Shionogi & Co (TYO:4507) and F2G reported positive late-stage trial results for their antifungal pill olorofim, tested in patients with invasive aspergillosis who cannot use standard azole treatments.
The trial found that olorofim worked just as well as the current intravenous treatment, with similar survival rates at 42 days-about 76% of patients in both groups were still alive, according to a Tokyo bourse filing on Thursday.
Importantly, the new pill caused far fewer side effects, especially kidney-related problems, which are a major concern with existing therapies.
The drug already holds FDA Breakthrough status, and the companies now plan to file for regulatory approval in the US, Europe, and Asia.
If approved, this would be the first new class of antifungal medicine in over 20 years, offering a much-needed oral alternative for vulnerable patients with weak immune systems.