Ibrexafungerp is the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids.
It has broad spectrum activity encompassing Candida, Aspergillus, Pneumocystis, Dimorphic fungi and mucorales, including multi-drug resistant (MDR) species and pan resistant species such as Candida auris. Ibrexafungerp combines the well-established activity of glucan synthase inhibitors with the flexibility of oral and IV formulations, offering a broad use across different settings (in-patient and out-patient).
Ibrexafungerp has the potential to be an essential therapy in the treatment of multiple serious fungal infections:
Fungicidal vs. Candida
High concentrations in tissues of interest, except CNS
~2,000 subjects exposed
Low risk of drug-drug interactions
Qualified Infectious Disease Product (QIDP), Fast Track and Orphan Drug status for invasive candidiasis and aspergillosis
Ibrexafungerp is an investigational drug. Items listed above illustrate ibrexafungerp target attributes.
Open-Label Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients with Refractory or Intolerant Fungal Diseases.
Open-Label Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients with Candidiasis Caused by Candida Auris.
A Phase 2 multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Coadministration of ibrexafungerp with voriconazole in Patients with Invasive Pulmonary Aspergillosis.
Global Phase 3 study to evaluate the efficacy, safety and tolerability of oral ibrexafungerp as a step-down therapy from an intravenous (IV) echinocandin in patients with invasive candidiasis (IC), including candidemia, a Candida infection in the blood.
Phase 3b, open-label, multicenter study to evaluate the efficacy, safety and tolerability of oral ibrexafungerp as a treatment for complicated vulvovaginal candidiasis (VVC) in patients who have failed treatment with fluconazole, based on mycological and clinical outcomes.