Refractory Invasive Fungal Infections

Refractory Invasive Fungal Infections

Life-threatening invasive fungal infections kill more than one million people in hospitals each year worldwide. (REF). Opportunistic infections caused by common fungal strains including Candida and Aspergillus can be life-threatening to people with compromised immune systems, such as those who are undergoing chemotherapy as a cancer treatment or those with organ transplants, immune disorders, diabetes, and advanced HIV infection (REF).

Ibrexafungerp for refractory invasive fungal infections

To address this, we are enrolling patients in our refractory invasive fungal infections (rIFI) programs, which are comprised of two global open-label Phase 3 studies (FURI and CARES) of oral ibrexafungerp for the treatment of invasive fungal infections.

The FURI study is a global Phase 3 study evaluating 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 CARES study is a global Phase 3 study evaluating oral ibrexafungerp for the treatment of invasive candidiasis caused by Candida auris, a new and emerging pathogen that is resistant to most antifungals, difficult to identify, can persist on surfaces in healthcare environments and spreads easily in a hospital setting with a high mortality rate of 30-60% (REF)”

Clinical Trial Results

Clinical Trial Results

Clinical Trial Results

Clinical Trial Results

Clinical Development Plan

Clinical Development Plan

Data from these studies will support a potential future NDA submission through the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD).  FDA’s LPAD guidance suggests smaller, shorter or fewer clinical trials may be sufficient to support approval to treat a serious infection in a limited population with unmet needs.