SCYNEXIS Announces Positive Results of Oral Ibrexafungerp to Treat Severe Fungal Infections

SCYNEXIS announced positive results from the third interim efficacy analysis of the ongoing open-label Phase 3 FURI study and the first interim analysis of the ongoing open-label Phase 3 CARES study.

The global, open-label Phase 3 FURI study is designed to evaluate oral ibrexafungerp as a salvage treatment for patients with a variety of difficult-to-treat mucocutaneous and invasive fungal infections that are refractory to, intolerant of current standards of care, or require a non-azole oral step-down therapy for the treatment of azole-resistant species. The global, open-label Phase 3 CARES study is focused on hospitalized patients with invasive candidiasis caused by the emerging Candida auris, an organism that is often multi-drug resistant, associated with high mortality and classified by the Centers for Disease Control and Prevention (CDC) as an Urgent Threat to public health. Furthermore, Candida auris has been shown to easily spread through contact in healthcare facilities, causing difficult-to-control outbreaks. Increased C. auris cases globally have been associated with higher rates of hospitalization due to the COVID pandemic.

Each study is intended to support a potential future NDA submission through the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD).

A Data Review Committee (DRC) of independent experts assessed the efficacy of oral ibrexafungerp in a third cohort of 33 patients from the FURI study and 10 patients from the CARES study. The third interim analysis of the FURI study showed that antifungal activity was consistently positive across all interim analyses with oral ibrexafungerp showing clinical benefit in 30 out 33 patients, and no patient with progression of disease. On an aggregate basis, oral ibrexafungerp showed clinical benefits in 86.5% of patients (64 out 74), with 46 patients achieving a complete or partial response and 18 patients achieving a stable disease response. Of the 74 treated patients, only five did not respond to ibrexafungerp treatment, one patient died of an underlying condition unrelated to the treatment and four patients were considered indeterminate.

Analysis of the CARES study found that 80% (8 out 10) patients with invasive candidiasis and candidemia, due to C. auris, experienced a complete response, and one patient died of an underlying condition unrelated to the treatment and one patient was considered indeterminate.

Oral ibrexafungerp exhibited a positive safety profile and was well-tolerated, with gastrointestinal issues cited as the most common treatment-related adverse events. There were no safety signals warranting changes to the studies.

“The consistently positive results from these analyses demonstrate the potential of oral ibrexafungerp to provide a flexible treatment option for combating serious life-threatening fungal infections, including those caused by the frequently drug-resistant Candida auris,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “The need for new anti-infectives capable of fighting the most resistant pathogens has never been more urgent as we confront the ongoing COVID-19 global pandemic. Ibrexafungerp is a versatile antifungal agent with potential to be a transformative therapy for multiple indications in both the hospital and community settings. It is currently under regulatory review for the treatment of vaginal yeast infections and, if approved, could be the first new antifungal class in more than two decades.”

“The strong results observed across the FURI and CARES trials are highly consistent with what has been previously reported despite the diversity of medical conditions and organisms being treated. We believe these results are indicative of ibrexafungerp’s broad-spectrum activity, which could provide a new valuable treatment option for patients suffering from a range of severe and often life-threatening fungal infections. We believe ibrexafungerp is the first investigational agent with reported clinical data in patients with C. auris infections and, given the historical difficulty of treating this pathogen, the results are particularly promising. We look forward to evaluating additional data as these trials continue to enroll patients,” David Angulo, M.D., Chief Medical Officer of SCYNEXIS, said.