Mundipharma and Cidara Therapeutics’ rezafungin has been granted an orphan drug designation from the European Commission for the treatment of invasive candidiasis (IC).
IC is a severe and life-threatening form of Candida infection of the bloodstream and/or deep or visceral tissues.
Although there are a number of available treatments for IC, mortality rates can be as high as 40%.
Rezafungin is a novel once-weekly echinocandin – this is a class of antifungal drugs that are designed to inhibit β (1, 3)-D- glucan synthase, an enzyme which plays a key role in the integrity of the fungal cell wall.
Mundipharma and Cidara Therapeutic’s drug is currently in Phase III development to evaluate its safety, tolerability and efficacy for the treatment of candidemia and IC compared to caspofungin.
Rezafungin is also being evaluated in another Phase III trial versus the standard antimicrobial regimen used to prevent invasive fungal disease due to Candida, Aspergillus and Pneumocystis in participants undergoing allogeneic blood and marrow transplantation.
“Orphan drug designation is an important milestone in the development of rezafungin, which is currently in Phase III clinical trials,” said Brian Sheehan, chief scientific officer of Mundipharma.
“Fungal infections still pose a major threat to the lives of hospitalised or immunocompromised patients. We are proud that patients affected with invasive candidiasis may have an additional treatment option to treat this potentially life-threatening condition,” he added.
