Phase III FURI study of ibrexafungerp shows positive clinical results in multiple fungal infections – Scynexis

Scynexis announced an oral presentation of analyses of interim data from its ongoing Phase III FURI study showing favorable clinical activity of oral Brexafemme (ibrexafungerp) in severe hospital-based fungal infections across multiple serious fungal infections. Data from an interim analysis of the combined data of 74 patients from the Phase III FURI clinical study evaluating oral ibrexafungerp for the treatment of patients with refractory candidiasis, patients who were intolerant to the standard of care, or patients who were unable to receive an approved oral antifungal option (e.g., susceptibility of the organism) and a continued IV antifungal therapy was clinically undesirable or unfeasible, found that oral ibrexafungerp provided an overall favorable therapeutic response in patients with 13 distinct types of fungal infections. Of the 74 patients treated with oral ibrexafungerp 62.1% showed complete or partial response, 24.3% achieved stable disease, 6.8% showed progressive disease, and 5.4% were indeterminate. One patient died due to an unrelated cause.

In the subset analysis by disease area, patients treated with ibrexafungerp who showed complete or partial response included those with: candidemia – 72.7% (8/11); intra-abdominal infections 58.3% (7/12) Candida infections of the bones and joints – 62.5% (5/8); and oropharyngeal candidiasis – 64.3% (9/14).

In addition, results from studies of oesophageal candidiasis (EC) and oropharyngeal candidiasis (OPC) were presented. These are infections that can be treated in the outpatient setting and are treated with oral azole therapy. When these patients fail oral azole therapy, they have limited intravenous treatment options and no oral options. The presentation highlights a sub-analysis of 24 patients (83.3% were refractory) from the Phase III FURI study with esophageal candidiasis (EC) or oropharyngeal candidiasis (OPC) treated with oral ibrexafungerp. Of these patients, 62.5% showed complete or partial response, 29.2% achieved stable disease and 16.7% showed progressive disease. The compilation and disease subset analyses are being presented during IDWeek, taking place virtually September 29 – October 3, 2021.