ReSTORE Phase III trial of rezafungin in candidaemia and invasive candidiasis published in The Lancet
Cidara Therapeutics announced the peer-reviewed publication of data from the completed pivotal ReSTORE Phase III clinical trial evaluating the efficacy and safety of its once-weekly antifungal candidate rezafungin as a potential treatment for candidemia and invasive candidiasis
The data, published in The Lancet titled, “Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): a multicentre, double-blind, double-dummy, randomised phase III trial,” demonstrate the statistical noninferiority of rezafungin dosed once-weekly, versus the current standard of care caspofungin, dosed once-daily.
Cidara reported positive topline results from ReSTORE in December 2021. Rezafungin met the primary endpoint for the FDA New Drug Application submission of all-cause mortality at Day 30, and also met the primary endpoint for the European Medicines Agency (EMA) Marketing Authorization Application (MAA) submission of global cure at Day 14. In the study, researchers evaluated one 400 milligram (mg) dose of rezafungin for the first week followed by 200 mg of rezafungin dosed once-weekly for up to four weeks in total. Rezafungin was generally well tolerated and had a similar safety profile to caspofungin.
See: "Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): a multicentre, double-blind, double-dummy, randomised phase 3 trial." Prof George R Thompson et al. The Lancet Published:November 25, 2022 DOI:https://doi.org/10.1016/S0140-6736(22)02324-8
The FDA has accepted for filing and granted Priority Review to Cidara’s NDA for rezafungin for the treatment of candidemia and invasive candidiasis. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 22, 2023, enabled by rezafungin’s designation as a Qualified Infectious Disease Product (QIDP) and has indicated that the application will be discussed during a scheduled meeting of the Antimicrobial Drugs Advisory Committee on January 24, 2023.
Related news and insights
Genentech, a member of the Roche Group announced positive results from the Phase III INAVO120 study of the investigational therapy, inavolisib, in combination with palbociclib (Ibrance) and fulvestrant as a potential first-line treatment option for people with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer
Exelixis, Inc. announced the initiation of STELLAR-305, a phase II/III pivotal trial evaluating zanzalintinib in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN)