Invasive Aspergillosis

What is Invasive Aspergillosis?

Invasive aspergillosis is a serious fungal infection caused by Aspergillus species and kills more than half of a million people each year worldwide. (REF)(REF)(REF). Aspergillus invades the lungs of immunocompromised patients and can spread to the bloodstream and other key organs leading to a high mortality rate of 30-80% (REF).

Current treatment guidelines recommend the use of azoles as the initial first-line therapy. However, patients face unsatisfactory clinical outcomes, with resistance to the standard of care, voriconazole, that can be as high as 20% (REF) and require long treatment durations. Current therapies also often exhibit drug-drug interactions, and the recent emergence of azole resistant A. fumigatus, one of the major causes of aspergillosis is increasingly becoming a clinical concern worldwide. Currently, aspergillosis cases are becoming an increasing problem among patients in the intensive care unit (ICU) suffering from COVID-19 (REF)”

Ibrexafungerp for Invasive Aspergillosis

Due to the significant rate of resistance, combination antifungal therapy is recommended as first-line treatment for patients suspected of invasive aspergillosis in some countries. We believe that ibrexafungerp's broad activity against Aspergillus spp., including azole-resistant strains, along with its minimal drug-drug interactions, high tissue penetration into the lungs and oral formulation allowing for convenient long-term administration, may make it an ideal candidate for use as combination therapy. Oral ibrexafungerp, if approved in combination with standard of care for the treatment of invasive aspergillosis, would allow patients to receive the required combination treatment of two agents with different mechanisms of action for the full six to twelve weeks of therapy, potentially improving patient outcomes. 

We are currently enrolling patients into our SCYNERGIA Study, a randomized, double-blind Phase 2 study of oral ibrexafungerp in combination with voriconazole (SoC) compared to voriconazole alone, in patients with invasive pulmonary aspergillosis.

Pre-Clinical Results

Pre-clinical results to date have been encouraging, indicating that combination therapy of ibrexafungerps (formerly SCY-078) and standard of care resulted in better efficacy vs. monotherapy for all efficacy parameters, including lower pulmonary infarct score and significant survival improvement.

If the combination of ibrexafungerp and standard of care is approved for the treatment of invasive Aspergillus infections and provides a significant improvement in clinical outcomes, ibrexafungerp as a combination therapy could replace the azole as the treatment of choice for this difficult-to-treat infection.

We reported data showing synergistic activity of ibrexafungerp in combination with an azole in both in vitro and in vivo models of invasive aspergillosis. A combination of ibrexafungerp and an azole would allow patients with invasive aspergillosis to receive this combination for the full 6 to 12 weeks of therapy, possibly leading to better outcomes.

Clinical Development Plan

Clinical Development Plan