Mundipharma and Cidara Therapeutics, Inc. presented data from the Phase 3 ReSTORE clinical trial of rezafungin in the treatment of candidemia and/or invasive candidiasis at the 32nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). The data, presented in a late-breaking poster, showed non-inferiority for rezafungin dosed once-weekly compared to caspofungin, the current standard of care, dosed once-daily, for both primary endpoints. Results from ReSTORE showed the primary endpoints were met with: 23.7% all-cause mortality on day 30 for rezafungin compared to 21.3% for caspofungin (difference, 2.4; 95% CI for risk difference -9.7 to 14.4*) global cure on day 14 of 59.1% for rezafungin and 60.6% for caspofungin (difference, -1.1; 95% CI for risk difference -14.9* to 12.7) *To meet the pre-specified limit of non-inferiority, the upper (for all-cause mortality) and lower (for global cure) 95% confidence limits for the difference between arms must be within 20%.

Both endpoints met the pre-specified 20% limit, establishing non-inferiority. Further data from the ReSTORE trial demonstrated high rates of early mycological efficacy with rezafungin: negative blood culture at 24 hours was 53.7% for rezafungin versus 46.2% for caspofungin and 74.2% versus 64.1% at 48 hours median time to negative blood culture was 23.9 hours for rezafungin versus 27.0 hours for caspofungin (p=0.175) Additional data from an oral late-breaking presentation at ECCMID from an integrated analysis of the Phase 2 STRIVE and Phase 3 ReSTORE data of rezafungin in the treatment of candidemia and/or invasive candidiasis, supports the analysis of ReSTORE2: 18.7% all-cause mortality on day 30 for rezafungin compared to 19.4% for caspofungin (weighted mortality difference, -1.5%; 95% CI: -10.7 to 7.7, stratified analysis by study) percentage of subjects with negative blood culture at 24 hours was 60.0% for rezafungin versus 49.1% for caspofungin and 77.7% versus 63.5% at 48 hours median time to negative blood culture was 22.3 hours for rezafungin versus 26.3 hours for caspofungin (p=0.0051).