Oral ibrexafungerp provides favorable therapeutic response in patients with fungal disease
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WASHINGTON — More than half of patients being treated with ibrexafungerp for challenging fungal diseases and limited treatment options saw complete or partial treatment response, according to data presented at IDWeek.
“There are limited oral treatment options for patients with fungal infections who fail currently available antifungals or have an infection caused by resistant organisms,” George R. Thompson III, MD, Infectious Disease News Editorial Board Member and professor of clinical medicine at the University of California, Davis, and colleagues wrote.
According to Thompson, ibrexafungerp — an investigational broad-spectrum glucan synthase inhibitor — has shown activity against Candida and Aspergillus species, including resistant strains.
Through a phase 3 open-label, single-arm study of ibrexafungerp called FURI, Thompson and colleagues further assessed the treatment of patients intolerant of standard antifungal therapy or with fungal disease resistant to standard treatments who were given ibrexafungerp.
According to the study, patients were eligible for FURI if they had proven or probable severe mucocutaneous candidiasis, invasive candidiasis, chronic or invasive aspergillosis, with documented evidence of failure, intolerance, or toxicity related to a currently approved standard-of-care antifungal treatment. Patients were also included if they could not receive approved oral antifungal options and continued IV antifungal therapy is clinically undesirable or unfeasible.
As part of FURI, 113 patients were enrolled at 27 facilities in the U.S., U.K. and EU and treated with ibrexafungerp for mucocutaneous or invasive fungal infections between 2016 and 2021. According to the study, 56 patients (49.5%) had invasive candidiasis/candidemia, 32 (28.3%) had mucocutaneous candidiasis, 14 (12.4%) had vulvovaginal candidiasis (VVC) and 11 (9.7%) patients had aspergillosis. An interim analysis showed that ibrexafungerp provided a favorable therapeutic response in patients with challenging fungal disease and limited treatment options.
Data showed that the percent of patients with complete or partial response — or for VVC, clinical improvement — was 58.4%, whereas stable disease was 23.9% and 11.5% had disease progression. Additionally, one death was reported due to underlying causes during FURI, whereas six outcomes were recorded as indeterminate.
“[Oral ibrexafungerp] really appears to provide a favorable therapeutic response for most patients regardless of the fungal pathogen that they had in this study,” Thompson said, during an IDWeek presentation. “So, with that, I think this is really a good option for patients who have failed or are intolerant to currently available regimens, and it is certainly a welcome addition for those who would otherwise need long-term IV therapy.”
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Thompson G, et al. Abstract 871. Presented at: IDWeek; Oct. 1923, 2022. Washington (hybrid meeting).
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