The results reported by Cidara Therapeutics, for its lead antifungal candidate rezafungin acetate, which met all of its primary objectives, show that once-weekly intravenous dosing of rezafungin was generally well tolerated and safe in patients with candidemia and/or invasive candidiasis.
According to the company’s report, these results enable Cidara to advance its planned Phase 3 pivotal trials in the treatment of candidemia and invasive candidiasis and the prevention (prophylaxis) of invasive fungal infections in 2018, as the data also showed evidence of the efficacy of rezafungin, which was defined in the trial by clearance of Candida from the blood or other normally sterile sites, resolution of signs related to the infection, investigator assessment of clinical response and overall survival.
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.
Jeffrey Stein, president and chief executive officer of Cidara noted that this is the first time that any antifungal has shown the potential to be a safe and effective once-weekly treatment option for patients with difficult-to-treat and deadly invasive Candida infections, which may enable patients to leave the hospital earlier, saving money and improving care.
“It is especially encouraging to note the consistent trends in relative outcomes improvement among patients on the rezafungin 400/200 regimen as compared to those on the comparator caspofungin. With these data in hand, we can confidently select the dosing regimens for our two upcoming Phase 3 pivotal trials of rezafungin in treatment and prophylaxis,” Stein said.