Cidara Therapeutics reported positive top-line results from Part B of the global Phase 2 STRIVE trial evaluating antifungal candidate rezafungin in the treatment of patients with candidemia and/or invasive candidiasis. In the STRIVE B trial, rezafungin met all of its objectives for efficacy, safety and tolerability. Rezafungin is being developed as a once-weekly therapy for the first-line treatment and prevention of serious invasive fungal infections.
STRIVE B was an international, multi-center, double-blind clinical trial evaluating the safety, tolerability and efficacy of once-weekly dosing of rezafungin acetate compared to once-daily dosing of caspofungin in patients with candidemia and/or invasive candidiasis. The trial enrolled 91 patients in the microbiological intent-to-treat, or mITT, population. Patients were randomized to receive either 400 mg of rezafungin administered intravenously once weekly for two to four weeks or daily caspofungin administered intravenously according to the approved prescribing information, with an optional step down to oral fluconazole. To align with the chosen dosing regimen in the Phase 3 program, the STRIVE B trial was amended midway to use rezafungin 400 mg for the first week followed by 200 mg once weekly for up to four weeks in total.
Cidara reported topline results from STRIVE A in March of 2018. Topline results from STRIVE B show that patients treated with rezafungin had numerically improved outcomes compared to caspofungin across all efficacy measures at the 400 mg/200 mg dosing regimen. In addition, an analysis combining data across STRIVE Parts A and B also demonstrates that rezafungin achieved meaningful improvement in outcomes compared to caspofungin across all efficacy endpoints at the same 400 mg/200 mg dose. The STRIVE trial was not powered to show statistically significant differences or non-inferiority between treatment arms.
A phase 3 trial, ReSTORE, is underway for the first-line treatment of candidemia and/or invasive candidiasis.
About Invasive Fungal Infections
Invasive fungal infections (IFIs) represent a serious threat to millions of patients worldwide, resulting in more than 1.5 million deaths annually and mortality rates ranging from 15 to 65 percent. These infections continue to be a global health issue, especially for critically ill patients in hospitals and patients with compromised immune systems, including cancer and transplant patients. Approximately 90 percent of IFI-related deaths are associated with Candida, Aspergillus, and Pneumocystis.
Rezafungin is a novel echinocandin antifungal and the only once-weekly drug candidate being developed for the first-line treatment and prevention of serious invasive fungal infections. Rezafungin has a unique pharmacokinetic profile with a prolonged half-life and front-loaded plasma exposure, which in contrast to all other echinocandins, allows for once-weekly IV therapy for inpatient and outpatient use. The U.S. Food and Drug Administration (FDA) has designated rezafungin as a Qualified Infectious Disease Product (QIDP) with Fast Track Status and Orphan Drug Designation related to its use in the treatment of candidemia and invasive candidiasis.