Benzinga | Jul 12, 2021 08:01AM EDT

Cidara Therapeutics Presents New Analyses from Multiple Rezafungin Studies at ECCMID 2021

Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics designed to transform the standard of care for patients facing serious fungal or viral infections, today announced new analyses from multiple studies of rezafungin, Cidara's novel, once-weekly echinocandin, under investigation in Phase 3 development for the treatment of candidemia and invasive candidiasis and prevention of invasive fungal infections, at the 31st European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). Cidara's oral presentation discusses new efficacy data from a sub-analysis of the previously completed STRIVE Phase 2 trial. The scientific program includes three e-Posters on rezafungin and real world echinocandin use.

"We are excited to present data, including new analyses from the STRIVE Phase 2 clinical trial, that reinforce rezafungin's potential as a therapy for the treatment of candidemia and invasive candidiasis," said Taylor Sandison, M.D., M.P.H., chief medical officer of Cidara. "We look forward to corroborating the results of our Phase 2 STRIVE program in our ongoing Phase 3 RESTORE trial in which we are testing whether the once-weekly, high front-loaded dosing of rezafungin can result in improved patient outcomes versus the daily dosing of standard of care. We are making significant progress in advancing the ReSTORE trial, with top-line data expected by the end of 2021."

Alex Soriano, M.D., Ph.D., chief of infectious diseases service, University of Barcelona, added, "There are significant shortcomings related to the current standards of care for fungal infections, defined by high rates of morbidity and mortality, and limited efficacy and therapeutic options, that do not meet the needs of patients. Importantly, if we can clear infections faster, we may be able to improve patient outcomes. Therefore, these data demonstrating significant reduction in time to negative blood culture compared to caspofungin underscore the potential impact of rezafungin on the candidemia and invasive candidiasis treatment landscape, and I look forward to seeing the Phase 3 results later this year."

Cidara's oral presentation, titled "Analysis of Efficacy from STRIVE Phase 2 Trial of Rezafungin Treatment of Candidemia and/or Invasive Candidiasis: Outcomes During Initial Days of Treatment," highlights a new sub-analysis from the STRIVE Phase 2 trial examining efficacy outcomes in the initial days of rezafungin treatment versus standard of care treatment with caspofungin. Key highlights include:

* The percentage of patients with negative blood culture at 24 and 48 hours was higher in the rezafungin group than in the caspofungin group, as were rates of mycological cure and overall success at Day 5.

* There was a statistically significant difference in the time to negative blood culture between rezafungin and caspofungin in patients with more aggressive infection, as defined by a positive blood culture between 12 hours before and 72 hours after enrollment.

* In the STRIVE trial, in more than 200 patients enrolled, safety and tolerability findings were comparable between treatments, consistent with the established safety profile of the echinocandin class.

* The ongoing Phase 3 ReSTORE trial (NCT03667690) will further contribute to the safety and efficacy database on rezafungin.

STRIVE was an international, multicenter, double-blind, trial evaluating the safety, tolerability and efficacy of once-weekly intravenous dosing of rezafungin compared to once-daily dosing of caspofungin in patients with candidemia and/or invasive candidiasis.

Key findings from Cidara's three e-Poster presentations are summarized below.