Cidara Therapeutics, Inc. (Nasdaq: CDTX), 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.”
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.
It was just announced two days ago that the FDA had granted fast-track and Qualified Infectious Disease Product (QIDP) designations to rezafungin for for the prevention of invasive fungal infections in adults undergoing allogeneic bone marrow transplantation. Cidara previously announced QIDP designation for rezafungin for the treatment of invasive fungal infections caused by Candida.
Over 90 percent of invasive fungal infections begin in the hospital setting. Invasive candidiasis and candidemia comprise the majority of invasive fungal infections in intensive care units, internal medicine and hematology wards within hospitals. Invasive candida infections are considered to be serious and life-threatening and are associated with high rates of morbidity and mortality. According to the Centers for Disease Control and Prevention (CDC) surveillance data, the 30-day all-cause mortality among people with candidemia is approximately 30 percent.
Rezafungin is a novel antifungal echinocandin being developed as a once-weekly, high-exposure therapy for the 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. Rezafungin is being studied to address unmet needs in the treatment of candidemia and invasive candidiasis as well as for prophylaxis (prevention) of invasive fungal infections, including Candida, Aspergillus and Pneumocystis in patients undergoing an allogeneic bone marrow transplant. In the recent Phase 2 STRIVE trial, data showed that once-weekly intravenous dosing of rezafungin was generally well tolerated and safe in patients with candidemia and/or invasive candidiasis.
The company reported topline results from its Ph II STRIVE trial in March of 2018. While Rezafungin met primary endpoints, investors were not initially impressed with the overall results.
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