Life-Threatening Infections
Invasive candidiasis
Immunocompromised patients vulnerable to some of the worst fungal infections.
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:
- Empiric treatment in the hospital for suspected cases
- Confirmed treatment in the hospital, typically for Intensive Care Unit (ICU), surgical patients and immunocompromised patients as well as patients using a central venous line
- Initial intravenous (IV) therapy for about five days (depending on the risk factors of the patient) with oral step-down for about two weeks
Ibrexafungerp for invasive candidiasis
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:
- Broad in vitro and in vivo anti-Candida activity
- Active against azole- and most echinocandin-resistant Candida strains, including multidrug resistant strains, including C. auris
- Developing in both oral and IV formulations, allowing first-line treatment and oral step-down with the same agent
- Fungicidal activity vs. Candida
- High tissue penetration, leading to high concentrations in the organs commonly affected by fungal infections
Deadly diseases.
Enormous unmet need.
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:
- The Centers of Disease Control and Prevention (CDC) has listed fluconazole-resistant Candida as a serious threat requiring prompt and sustained action and has also identified a rise in echinocandin resistance, especially among Candida glabrata.
- The CDC has issued an extraordinary alert for healthcare facilities and providers to be on the lookout for patients with C. auris, a multidrug-resistant strain with high mortality.
- The World Health Organization (WHO) recently published its first ever list of fungal “priority pathogens” of the 19 fungi that represent the greatest threat to public health. According to WHO, populations at greatest risk of invasive fungal infections include those with cancer, HIV/AIDS, organ transplants, chronic respiratory disease, and post-primary tuberculosis infection.
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.
Investigating ibrexafungerp as a step-down therapy for invasive candidiasis
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.
Clinical trials
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.
Our data on invasive infections
SCYNEXIS regularly presents key infectious disease study data at top medical meetings.
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