Safety and Pharmacokinetics of Isavuconazole
Invasive fungal infections are associated with significant morbidity, mortality, and health care costs in patients with haematologic malignancies.
Allogeneic haematopoietic stem cell transplantation and chemotherapy-associated neutropenia place patients with acute myeloid leukaemia (AML) at risk of developing invasive fungal infection. Aspergillus spp. and Candida spp. are the predominant fungal pathogens in patients with acute leukaemia. However, other moulds, such as the Mucorales, Scedosporium spp., and Fusarium spp., are emerging as pathogens in this clinical setting and are associated with high substantial mortality and unacceptable mortality rates. Because invasive fungal infections are often difficult to diagnose, and delays in treatment can significantly increase the risk of mortality, antifungal prophylaxis has become a commonly used strategy in patients at high risk of IFIs. However, that approach is only applicable to patients identified in advance of carrying a high risk of infection.
FungiResearch was founded after a common open-label, sequential-cohort, phase 2 study was successfully completed to assess the safety and tolerability and to define the phase 3 dosing scheme of the new antifungal Isavuconazole.
Isavuconazole is a novel triazole antifungal now licensed for the treatment of aspergillosis and mucormycosis. The phase 2 development programme of Isavuconazole anchored in a prophylactic setting as the fastest way determining pharmacokinetics (PK) and safety in a target patient population with a high medical need.