Interim analysis of phase III FURI study of ibrexafungerp shows positive results in fungal infections.- Scynexis

Scynexis announced positive results from the first interim efficacy analysis of the ongoing FURI study, a Phase III open-label study evaluating oral ibrexafungerp (formerly SCY 078) as a salvage treatment in patients with difficult-to-treat mucocutaneous and invasive fungal infections that are refractory to or intolerant of currently available standards of care. An independent expert panel (Data Review Committee) assessed the efficacy of ibrexafungerp in the first 20 treated patients.

Oral ibrexafungerp showed clinical benefits in 17 out of 20 patients, with 11 patients achieving a complete or partial response and six patients a stable disease response. Only two patients did not respond to ibrexafungerp treatment and the outcome for one patient was considered indeterminate. Along with demonstrating the ability to treat fungal infections in vulnerable patients who failed other therapies, these preliminary results support continued patient enrollment in the FURI study to build toward a future New Drug Application (NDA) submission and potential approval through the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD).

Oral ibrexafungerp was well-tolerated, with the most common treatment-related adverse events being gastrointestinal. There were no deaths due to progressive fungal disease and no safety signals warranting changes in the study. The company plans to provide additional details and patient cases of this interim analysis at an upcoming scientific meeting.