Oral Ibrexafungerp Effective & Well-Tolerated in FURI Phase 3 Trial

Investigators of a recent phase 3 trial showed that oral ibrexafungerp (formerly SCY-078) may be a well-tolerated and effective treatment for invasive candidiasis infections that could help patients avoid the need for long-term IV treatment and hospital stays.

Investigators from Medical University of Graz in Austria and Synexis Inc. examined 4 invasive candidiasis cases treated with oral ibrexafungerp as part of the FURI open-label phase 3 trial. The trial is evaluating the safety and efficacy of the treatment for adults with invasive fungal infections who are intolerant of or refractory to standard treatments or for whom long-term IV treatment is not feasible.

“Ibrexafungerp was safe and effective in our patients,” Juergen Prattes, MD, of the Medical University of Graz, Section of Infectious Diseases and Tropical Medicine, told Contagion^®. “Inpatient hospital stay could be shortened significantly.”

The study was accepted for presentation at the 2020 European Congress on Clinical Microbiology and Infectious Diseases (ECCMID), which was canceled due to the coronavirus 2019 (COVID-19) pandemic.

Ibrexafungerp functions similarly to echinocandins, working as an inhibitor of of 1,3-ß-D-glucan synthesis of the fungal cell wall, and offers an oral alternative for treating candida strains resistant to echinocandins.

In the study, 2 of the patients had malignancy, 1 had psoriatic arthritis and 1 had kidney/pancreas transplantation.

The patients were treated with ibrexafungerp for a range of 7-75 days for femoro-tibial osteomyelitis due to C. glabrata and C. albicans (resulting in partial response), candidemia due to C. parapsilosis (full response), intraabdominal abscess due to C. krusei (full response), and oropharyngeal candidiasis due to C. krusei and C. albicans (stable response with persisting thrush).

Diarrhea was the most common adverse events, affecting 3 of the patients and resolving after a couple of days for 2 patients. Other adverse events included nausea, rash and tooth discoloration, each affecting 1 patient.

“Ibrexafungerp may be a valuable oral treatment option in patients with invasive candidiasis, especially in those patients intolerant or refractory to standard antifungal treatment or in whom long term IV treatment is not feasible,” Prattes told Contagion^®.

Candida infections are growing threat and are typically more resistant to current antifungal therapies, raising interest in the development of new treatments.

A multinational, open-label phase 2 study of ibrexafungerp published last year found that a 750 mg daily dose of oral ibrexafungerp was well-tolerated and had a response rate similar to the standard of care (oral fluconazole or IV micafungin). That study tested the drug as a step-down treatment after initial intravenous echinocandin therapy.

An initial assessment of the drug was highlighted at last year’s European Congress for Clinical Microbiology and Infectious Diseases (ECCMID 2019) in Amsterdam, The Netherlands.