Ibrexafungerp Shows Favorable Response to Candida Infections in FURI Initial Assessment

Candida is making front-page headlines in the mainstream media, demonstrating that the emerging threat has only continued to grow. It is an important fact that infections caused by non-albicans Candida are serious, as they are occurring more frequently in clinical settings and are typically more resistant to current antifungal therapies.

Ibrexafungerp (formerly SCY-078) is a novel intravenous/oral broad-spectrum glucan synthase inhibitor (triterpenoid) antifungal that is being developed by SCYNEXIS to treat infections caused by Candida, Aspergillus, and Pneumocystis, including resistant strains.

Oral ibrexafungerp is currently being evaluated in a phase 3 open-label, single-arm study called FURI. The trial is evaluating the agent for the treatment of fungal diseases in patients who are 18 years and older and who are intolerant of or refractory to standard antifungal therapies.

An independent data review committee has released an initial assessment of treatment response for the first 20 patients of the trial who have completed therapy. The results of the initial assessment were presented in an oral abstract session at the European Congress for Clinical Microbiology and Infectious Diseases (ECCMID 2019).

At the conference, Contagion® spoke to an author of the abstract, Jose Vazquez, MD, chief of infectious disease at Medical College of Georgia, who is also a member of the Contagion® Editorial Advisory Board (see video).

The study participants were enrolled at 14 treatment centers across 4 countries. Individuals with “proven or probable, invasive or severe mucocutaneous candidiasis and documented evidence of failure of, intolerance to, or toxicity related to a currently approved standard-of-care antifungal treatment or could not receive approved oral antifungal options (eg, susceptibility of the organism) and a continued intravenous (IV) antifungal therapy was undesirable or unfeasible” were eligible for enrollment.

The 20 patients who were included in the initial assessment results had esophageal candidiasis, intra-abdominal abscesses, and oropharyngeal candidiasis, candidemia, endocarditis, and mediastinitis, among other infections.

The data review committee adjudicated 11 of the 20 participants (55%) as achieving a complete or partial response. Additionally, 6 patients (30%) were regarded as maintaining stable disease, 2 patients (10%) were noted to have progression of disease, and 1 case was considered as indeterminate.

More specifically, infection with C glabrata resulted in 6 complete and partial responses, 3 stable disease cases, and 2 progressive diseases cases. Infection with C kruseii resulted in 1 complete and partial response and 2 stable disease cases. C albicans led to 2 complete and partial responses and 1 stable disease case. For C parapsilosis, 1 complete and partial response was noted, as was 1 case of an unidentified pathogen.

According to the investigators, the agent was well-tolerated overall with the most common adverse event being of gastrointestinal origin. No deaths due to progression of disease were noted.

“Preliminary analysis of these 20 cases indicate that oral ibrexafungerp provides a favorable therapeutic response in the majority of patients with difficult to treat Candida [species] infections, including those caused by non-albicans Candida species,” the investigators concluded.

The study, “Favorable Response to Oral Ibrexafungerp (formerly SCY-078) in Patients with Refractory Fungal Diseases, Interim Analysis by Pathogen from a Phase 3 Open-label Study (FURI),” was presented in an oral abstract presentation on April 15, 2019, at ECCMID 2019 in Amsterdam, the Netherlands.