Outcomes of Oral Ibrexafungerp in Subjects with Intraabdominal Candidiasis from a Phase 3 Study (FURI)

Author(s):
David Kriesel; Thomas Chen; Nkechi Azie

Background:

Intraabdominal Candidiasis (IAC) is the second most common form of invasive candidiasis after candidemia. Candida albicans is still the most common organism causing IAC, but the number of non-albicans Candida species causing IAC is growing. Tissue penetration has been identified as a limitation of echinocandin treatment.

Hypothesis:

Ibrexafungerp (IBX) is a glucan synthase inhibitor with excellent tissue penetration and oral bioavailability. We review outcomes of 17 subjects with IAC from the FURI study (NCT03059992).

Methods:

FURI is an ongoing Phase 3 open-label single-arm study of oral IBX for the treatment of adult subjects with fungal diseases, refractory, resistant to or intolerant of Standard of Care (SoC) antifungal therapies. IAC subjects were eligible for enrolment if they had proven or probable invasive candidiasis with or without candidemia and met protocol defined criteria for refractoriness, resistance or intolerance. Subjects received a loading dose of oral IBX  750 mg BID for 2 days followed by 750 mg QD with a duration of therapy for a minimum of 14 days and up to 180 days. Global response at End of Treatment (EOT) was adjudicated by an independent data review committee (DRC).

Results:

17 subjects had a diagnosis of IAC. 82% (14/17) were enrolled based on refractoriness to current treatment, and 71% (10/14) of refractory patients had previously failed to an echinocandin therapy. There were 19 Candida isolates identified in the 17 subjects. The predominant organism was C. glabrata 42% (8/19) with non-albicans Candida isolates (C. glabrata, C. krusei, C. tropicalis) predominant 67% (12/19). Outcomes for these subjects were as follows: Complete or Partial Response was 53% (9/17), Stable Disease was 41% (7/17) and Progression of Disease 6% (1/17). One subject died during the study and was attributed to other causes and not their fungal disease.

Conclusions:

Preliminary analysis of these 17 cases indicate that oral IBX is a promising orally available option for the treatment of IAC patients with limited therapeutic options.