A phase 2b study subanalysis indicates that olorofim may provide a treatment option for patients with disseminated Valley Fever who have failed standard therapies.
RT’s Three Key Takeaways:
- Salvage Treatment Potential: Olorofim showed clinical improvement in over 70% of patients with disseminated Valley Fever who were resistant or intolerant to existing antifungal medications.
- Targeted Efficacy: The drug specifically addresses disseminated coccidioidomycosis, a complication where the infection spreads from the lungs to other parts of the body.
- Manageable Safety Profile: While elevated liver enzymes were the most common side effect observed in the study, they were generally managed through monitoring or dose adjustments.
Researchers from the Valley Fever Center for Excellence at the University of Arizona found that olorofim, a first-in-class orotomide antifungal agent, showed efficacy in treating disseminated coccidioidomycosis (DCM), according to a study published in Annals of Internal Medicine.
DCM is a rare complication of Valley Fever where the fungus spreads from the lungs to other parts of the body. Olorofim, which does not currently have FDA approval, showed potential as a salvage treatment for patients for whom standard-of-care therapies have failed.
The study assessed the safety, tolerability, and effectiveness of oral olorofim in 41 patients aged 16 and older between May 2019 and August 2022. The participants had disseminated DCM that was predicted to be resistant to licensed antifungal agents, had not shown improvement despite the use of these medications, had significant drug–drug interactions, or had developed intolerance to antifungal therapy.
Participants received olorofim either alone or alongside standard care over an 84-day period. By day 42, approximately 76% of patients showed clinical improvement, and 73% showed improvement by day 84, according to the research.
The most common side effect observed was elevated liver enzymes. These instances were generally managed with monitoring or dose adjustments.
Although the study did not include a comparison group, the findings warrant further study, said Fariba M Donovan, corresponding author.
