A once-weekly treatment for deadly fungal infections from Cidara Therapeutics and Mundipharma, rezafungin demonstrated positive results in its phase 3 clinical trial.
Today, Cidara Therapeutics and Mundipharma reported positive results from the phase 3 clinical trial of their once-weekly antifungal injectable, rezafungin, to treat candidemia and invasive candidiasis.
Administered once a week, rezafungin demonstrated statistical non-inferiority as compared to a daily dose of caspofungin, the current standard of care.
In the phase 3 ReSTORE trial, rezafungin met the US Food and Drug Administration’s (FDA) New Drug Application (NDA) primary endpoint of all-cause mortality at day 30. Additionally, rezafungin met the primary endpoint for the European Medicines Agency’s (EMA) Marketing Authorization Application (MAA) submission of global cure at Day 14.
Jeffrey Stein, PhD, president and CEO of Cidara, said, “The results of the ReSTORE trial reinforce our belief that rezafungin has the potential to have a significant impact on the care of patients battling difficult-to-treat and often deadly invasive Candida infections. We are pleased by the overall efficacy and safety results including the data on early efficacy outcomes and ICU stay.”
ReSTORE (NCT03667690) is a global, randomized, double-blind, controlled phase 3 study. ReSTORE enrolled 187 patients diagnosed with candidemia and/or invasive candidiasis in 132 clinical sites across 18 countries. The ReSTORE trial evaluated 1 400 mg loading dose of rezafungin for the first week, and 200 mg of rezafungin once a week for up to 4 weeks. The rezafungin treatment arm was compared to once daily caspofungin in a 1:1 randomization.
At day 14, rezafungin had a global cure of 59.1%, as compared to caspofungin’s cure rate of 60.6%. Rezafungin dramatically reduced the length of ICU stay, for an average of 5 days versus 14.5 days for caspofungin patients.
Rezafungin is a once-a-week echinocandin in development to treat and prevent serious fungal infections like candidemia and invasive candidiasis. Rezafungin is designed to improve upon existing treatments to advance the efficacy and safety potential for patients. In addition to the ReSTORE trial, Cidara is currently conducting the phase 3 ReSPECT trial to analyze rezafungin’s ability to prevent invasive fungal disease in patients undergoing allogenic blood and marrow transplantation.
Rezafungin was designated a Qualified Infectious Disease Product (QIDP) with Fast Track status by the FDA, and was granted Orphan Drug Designation to treat invasive candidiasis in the US and EU.
“With the results of both the STRIVE and ReSTORE trials now in hand, which together form our registration package, we intend to file our NDA with the FDA and other regulators outside the US, in mid-2022,” Stein said.