Invasive candidiasis (IC) is a serious fungal infection caused by various Candida species and occurs most frequently in immunocompromised patients. Candida is the most common cause of healthcare-associated bloodstream infections in the U.S. The overall mortality rate of invasive candidiasis remains over 30%, despite therapy.
Current treatment options are limited to only three antifungal classes, with the few therapies becoming increasingly ineffective due to a rise in drug resistant strains.
The current treatment protocol for IC includes:
We are developing ibrexafungerp as an oral antifungal step-down therapy for the treatment of multiple invasive fungal infections. Ibrexafungerp’s unique combination of attributes potentially enable it to address significant unmet medical needs in treating IC:
Despite existing antifungal agents, mortality in this high-risk patient population remains high (up to 30%). Additionally, the increasing emergence of drug-resistant Candida strains has created an urgent need for new treatments:
Current treatment guidelines for IC recommend the use of IV echinocandins as first-line therapy for empiric and confirmed cases. If approved for the treatment of IC, ibrexafungerp may provide an alternative to current IV echinocandin use and may fulfill the significant current unmet needs in the oral maintenance setting.
SCYNEXIS is conducting a Phase 3 global study (MARIO) to evaluate the efficacy, safety and tolerability of oral ibrexafungerp as a step-down therapy from an IV echinocandin in patients with IC, including candidemia, a Candida infection in the blood.
If approved, oral ibrexafungerp would be the first non-azole oral therapy available for invasive candidiasis and would enable an IV-to-oral transition with a consistent mechanism of action. Like IV-only echinocandins, oral ibrexafungerp acts via glucan synthase inhibition, a mechanism which has been demonstrated to be the most effective for treating invasive Candida diseases. IC is a systemic infection typically affecting patients with an underlying disease or condition, such as those who are post-transplant, post-surgery, in intensive care units, or those receiving immunosuppressive treatments. IC has a high mortality rate and often involves the blood and other organs, such as liver, spleen and bone.
SCYNEXIS is researching the efficacy of ibrexafungerp in fighting refractory invasive fungal infections. Two of our key global open-label Phase 3 studies of oral ibrexafungerp for the treatment of invasive fungal infections are focused in this area.