Invasive aspergillosis is a serious fungal infection caused by Aspergillus species that kills more than half of a million people each year worldwide. 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 to 80%.
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% 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 a rapidly growing problem among patients in the intensive care unit suffering from COVID-19.
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 and 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.
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.