6/29/23, 1:13 AM ReSTORE Pathway Feedback Search Clinical Topics Home Studies ReSTORE ReSTORE Disease Invasive candidiasis Trial question Is rezafungin noninferior to caspofungin in patients with candidemia and invasive candidiasis? Study design Multi-center Double blinded RCT Population Characteristics of study participants 41.0% female N = 199 59.0% male 199 patients (81 female, 118 male) Inclusion criteria: adult patients with systemic signs and mycological confirmation of candidemia or invasive candidiasis Key exclusion criteria: septic arthritis in a prosthetic joint; osteomyelitis; chronic disseminated candidiasis; severe hepatic impairment; severe ataxia; tremor; or neuropathy Interventions N=100 rezafungin (400 mg in week 1, followed by 200 mg weekly, for a total of two to four doses for no more than 4 weeks) N=99 caspofungin (70 mg loading dose on day 1, followed by 50 mg daily for no more than 4 weeks) https://web.pathway.md/studies/rec9vPU4TpyYscblP 1/2 6/29/23, 1:13 AM ReSTORE Pathway Primary outcome Global cure at day 14 61.0 % 61 59 45.8 % 30.5 % Difference not exceeding nonferiority margin 15.3 % 0.0 % Rezafungin Caspofungin Difference not exceeding nonferiority margin in global cure at day 14 (59% vs. 61%; ARD -2, 95% CI -4 to 0) Secondary outcomes No significant difference in death or unknown survival status at day 30 (24% vs. 21%; AD 3%, 95% CI -0.01 to 6.01) Safety outcomes No significant differences in serious adverse events, 1 treatment-emergent adverse event. Conclusion In adult patients with systemic signs and mycological confirmation of candidemia or invasive candidiasis, rezafungin was noninferior to caspofungin with respect to global cure at day 14. Reference George R Thompson rd, Alex Soriano, Oliver A Cornely et al. Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): a multicentre, double-blind, double- dummy, randomised phase 3 trial. Lancet. 2023 Jan 7;401(10370):49-59. Open reference URL https://web.pathway.md/studies/rec9vPU4TpyYscblP 2/2