A subanalysis of a single-group, open-label, phase 2b study found that olorofim, a first-in-class orotomide antifungal agent that does not have U.S. FDA approval, showed efficacy in patients with disseminated coccidioidomycosis (DCM), a rare complication of Valley Fever where the fungus spreads from the lungs to other parts of the body.
The findings show the potential of olorofim as salvage treatment for patients for whom standard-of-care therapies have failed. The findings are published in Annals of Internal Medicine.
Researchers from the Valley Fever Center for Excellence at the University of Arizona and colleagues assessed the safety, tolerability, and effectiveness of oral olorofim in 41 patients aged 16 and older from May 2019 to August 2022. The patients had disseminated DCM that was predicted to be resistant to licensed antifungal agents, had not shown improvement despite use of these medications, had significant drug–drug interactions, or had developed intolerance to antifungal therapy.
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Participants received olorofim either alone or alongside standard care over an 84-day period. By days 42 and 84, about 76% and 73% of patients showed clinical improvement, respectively. The most common side effect was elevated liver enzymes, which was generally managed with monitoring or dose adjustments.
Although the study did not include a comparison group, the researchers say the findings warrant further study.
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