Positive results in Phase III trial of candidemia and invasive candidiasis

pharmafile | December 15, 2021 | News story | Research and Development  

Cidara Therapeutics and Mundipharma have announced positive topline data from the ReSTORE Phase III clinical trial, evaluating the efficacy and safety of the once-weekly antifungal candidate rezafungin as a potential first-line treatment for candidemia and invasive candidiasis.

Invasive candidiasis (IC) continues to be an area of significant unmet need, especially for critically ill patients in hospitals, and patients with compromised immune systems. Despite a number of available treatments, mortality rates are as high as 40%. IC is an infection that can be caused by various species of Candida yeast. Unlike other Candida infections, IC is a serious, progressive, and potentially fatal infection that can affect the blood (fungemia), heart, brain, eyes, bones, and other parts of the body.

“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,” said Jeffrey Stein, PhD, president and  CEO of Cidara. “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. With the results of both the STRIVE and ReSTORE trials now in hand, which together form our registration package, we intend to file our NDA with the FDA and other regulators outside the US, in mid-2022.”

“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,” Brian Sheehan, PhD, chief scientific officer at Mundipharma said.

Ana Ovey

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