Cidara Therapeutics Inc. (NASDAQ: CDTX) and Mundipharma have announced topline results from the vital ReSTORE third phase clinical study evaluating the safety and efficacy of its once per week antifungal candidate rezafungin as a potential first-line therapy for invasive candidiasis and candidemia.
ReSTORE achieved the primary endpoint of all-cause mortality
Rezafungin achieved the primary endpoint of all-cause mortality at Day 30, supporting the FDA New Drug Application (NDA) submission and the primary endpoint of global cure at Day 14 for the European Medicines Agency (EMA) Marketing Authorization Application submission. Both results showed that rezafungin dosed weekly was statistically non-inferior to caspofungin dosed daily, the current standard of therapy. In addition, Rezafungin was typically well accepted, and its safety profile was similar to that of caspofungin.
Cidara CEO Jeffery Stein said, “The results of the ReSTORE trial reinforce our belief that rezafungin has the potential to have a significant impact on the care of patients battling difficult-to-treat and often deadly invasive Candida infections. We are pleased by the overall efficacy and safety results including the data on early efficacy outcomes and ICU stay. We would like to thank all of the investigators and their site staff for their relentless hard work and dedication, as well as the patients who made it possible for us to generate these data.”
Rezafungin could present a treatment alternative once approved
ReSTORE study principal investigator George Thompson commented, “Those of us treating deadly fungal infections have been anticipating these data and if rezafungin is approved it could be an important new option for the care of our patients. I’m excited that the data from the ReSTORE trial support a potential place for once-weekly rezafungin in the treatment of critically ill patients both inside and outside the hospital.”
Mundipharma Chief SAcientific Officer Brian Sheehan stated, “We are thrilled to announce these data that support the potential use of once-weekly rezafungin which, if approved, will be the first new treatment option for patients with candidemia and/or invasive candidiasis in over a decade.”
