Cidara Therapeutics, Inc., a biotechnology company developing novel anti-infectives including immunotherapies, today announced that the first trial site has been activated for ReSTORE, a Phase 3 clinical trial evaluating the efficacy and safety of the company's lead antifungal, rezafungin, to treat candidemia and invasive candidiasis. Rezafungin is a novel echinocandin antifungal being developed as a once-weekly, high-exposure therapy for the treatment and prevention of serious invasive fungal infections.
"Given the compelling data from our Phase 2 program, we are very pleased to initiate our global Phase 3 program of rezafungin," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "Difficult-to-treat, invasive Candida infections are associated with a high mortality and affect the most vulnerable patients. Rezafungin has the potential to be the first new antifungal approved for this indication in over a decade and, given how the drug works, it has the potential to improve outcomes for patients and allow them to leave the hospital earlier, resulting in reduced healthcare costs."
ReSTORE is a global, randomized, double-blind, controlled Phase 3 pivotal clinical trial evaluating the efficacy and safety of once-weekly intravenous dosing of rezafungin compared to once-daily dosing of caspofungin in patients with candidemia and/or invasive candidiasis. The trial design will be similar to the company's Phase 2 STRIVE study, which met its primary safety and efficacy objectives. The ReSTORE trial is designed to evaluate one rezafungin dosing regimen of 400 milligrams (mg) for the first week followed by 200 mg of rezafungin once weekly for up to four weeks in total. This treatment arm will be compared to caspofungin in a 1:1 randomization.
The primary efficacy endpoint of ReSTORE, which will be used for a U.S. Food and Drug Administration (FDA) New Drug Application submission, is all-cause mortality at day 30. The primary efficacy endpoint for the European Medicines Agency (EMA) is expected to be global response at day 14.
"I am very enthusiastic about the initiation of this important trial of rezafungin as a once-weekly echinocandin which may offer a new solution for patients and physicians to treat serious invasive Candida infections," said Cornelius J. Clancy, M.D., Associate Professor of Medicine and Director of the Mycology Research Unit and XDR Pathogen Lab at the University of Pittsburgh. "There is an urgent and growing need for new therapeutic approaches for these infections, which typically afflict highly vulnerable patients, including those who are critically ill and have compromised immune systems. Rezafungin has the potential to overcome the significant limitations associated with current standards of care such as sub-optimal dosing, increasing resistance, drug-drug interactions and toxicities, all of which complicate therapy in patients who are already ill."
The ReSTORE trial will enroll approximately 184 modified intent-to-treat, or mITT, patients and is expected to generate topline data in 2020. This global trial is anticipated to be conducted at approximately 100 clinical trial centers across the United States, Europe, Asia and Australia.