Rezafungin Gets Fast Track, QIDP Status for Prevention of Invasive Fungal Infections
Cidara Therapeutics announced that the Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations to rezafungin for the prevention of invasive fungal infections in adults undergoing allogeneic bone marrow transplantation. Previously, rezafungin was granted QIDP for the treatment of invasive fungal infections caused by Candida.
Rezafungin, a novel broad-spectrum antifungal belonging to the echinocandin class, is being developed as a once-weekly, high-exposure therapy for the treatment of serious invasive fungal infections, including candidemia and invasive candidiasis, as well as for prophylaxis of invasive fungal infections due to common fungal pathogens (Candida, Aspergillus, and Pneumocystis).
The Phase 3 ReSPECT prophylaxis trial of rezafungin in patients undergoing allogeneic bone marrow transplantation is anticipated to start in the first quarter of 2019. The trial will compare rezafungin in a 90-day prophylaxis regimen vs a 2-drug regimen (an azole antifungal + sulfamethoxazole/trimethoprim) given once daily for 90 days; the primary outcome measure of the study will be fungal-free survival.
“We now have the opportunity to expedite the development of rezafungin to address significant unmet needs both in the prevention of invasive fungal infections in immunocompromised patients undergoing bone marrow transplantation, as well as for the treatment of patients with existing severe invasive fungal infections," stated Jeffrey Stein, PhD, president and CEO of Cidara.
For more information visit Cidara.com.