Mundipharma and Cidara Therapeutics report positive Phase III results into candidemia treatment
pharmafile | April 26, 2022 | News story | Medical Communications |
Mundipharma and Cidara Therapeutics have presented data from the Phase III ReSTORE trial of rezafungin, in the treatment of candidemia and/or invasive candidiasis.
The data show non-inferiority for rezafungin dosed once-weekly compared to caspofungin, the current standard of care, dosed once-daily, for both primary endpoints.
“The results of both the STRIVE and ReSTORE trials, as well as the pharmacokinetics data, provide clear evidence of the potential impact that rezafungin could have for patients fighting serious and hard to treat invasive Candida infections,” said Jeffrey Stein, PhD, President and CEO of Cidara. “We look forward to submitting our NDA to the FDA in mid-2022 and subsequent ex-US submissions, and to making a difference in the lives of patients.”
Oliver Cornely investigator in the ReSTORE trial and Professor of Internal Medicine at the University of Cologne, Germany, added, “As the mortality rate for patients with invasive candidiasis remains high there is a real unmet need for new treatment options to address this serious disease. Rezafungin could be the first new treatment option for patients with candidemia or invasive candidiasis for over 10 years.”
Brian Sheehan, PhD, CSO at Mundipharma, added, “We are extremely pleased that these data presented today may help pave the way for once-weekly rezafungin to help critically ill patients with invasive Candida infections. The results from these important trials provide initial evidence that the unique pharmacokinetic/pharmacodynamic profile of rezafungin may lead to quicker fungal clearance for patients with Candida infections.”
Mundipharma has commercial rights to rezafungin outside the US and Japan.
Lina Adams
