Results from ReSTORE showed the primary endpoints were met with: 1
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: 1 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)
Both the STRIVE and ReSTORE trials demonstrated similar tolerability outcomes for rezafungin and caspofungin and did not reveal any concerning trends in TEAEs or SAEs.1,2
Further data presented at ECCMID assessing the pharmacokinetics of drug interactions between rezafungin and anticancer agents venetoclax or ibrutinib demonstrated that in subjects receiving multiple drug interventions, rezafungin can be given with no dose adjustments due to pharmacokinetics. 3
'The results of both the STRIVE and ReSTORE trials, as well as the pharmacokinetics data, provide clear evidence of the potential impact that rezafungin could have for patients fighting serious and hard to treat invasive Candida infections,' said
Cidara has partnered with
About ReSTORE
ReSTORE (NCT03667690) is a global, multicentre, randomized, double-blind, controlled Phase 3 efficacy and safety study of once weekly rezafungin injections versus an active comparator regimen of caspofungin followed by optional oral fluconazole step-down therapy in subjects with candidemia and/or invasive candidiasis. ReSTORE evaluated one 400 milligram (mg) dose of rezafungin in week 1 followed by 200 mg of rezafungin dosed once-weekly for up to four weeks. The treatment arm was compared to approved daily dosing of caspofungin in a 1:1 randomization (n=98 in each arm).1 It completed enrollment with 199 patients diagnosed with candidemia and/or invasive candidiasis in 66 clinical sites across 18 countries. Study sites in
About STRIVE
STRIVE (NCT02734862) was a global, multicenter, randomized, double-blind Phase 2 study of the safety, tolerability, and efficacy of intravenous rezafungin (n=138)2 versus intravenous caspofungin (n=69)2 followed by optional oral fluconazole step-down in the treatment of subjects with candidemia and/or invasive candidiasis. It was completed with 207 participants enrolled in 63 clinical sites across 10 countries.
About Pharmacokinetics Study
An open-label study of 16 male and 16 female healthy volunteers assessed drug-drug interactions between rezafungin and anticancer agents 280mg ibrutinib or 50mg venetoclax (females only). The two anticancer agents were each given along and with IV rezafungin (400mg followed by once-weekly 200mg).3
About 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 available treatments, the mortality rate for patients with invasive candidiasis remains as high as 40%.4 IC is characterized as a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues, known as candidemia and deep-seated tissue candidiasis.5
About Rezafungin
Rezafungin is a next-generation once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as invasive candidiasis and candidemia. The structure and properties of rezafungin are specifically designed to enhance its efficacy and safety potential for patients. Cidara has completed a Phase 3 clinical trial with rezafungin for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE trial).4
Cidara is also currently conducting a second Phase 3 clinical trial of rezafungin for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (ReSPECT trial).
Rezafungin has been designated a Qualified Infectious Disease Product (QIDP) with Fast Track status by the FDA and has been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in both the
About
Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The Company's portfolio is comprised of new approaches aimed at transforming existing treatment and prevention paradigms, first with its lead Phase 3 antifungal candidate, rezafungin, in addition to drug-Fc conjugates (DFCs) targeting viral and oncology diseases from Cidara's proprietary Cloudbreak platform. Cidara is headquartered in
About
Forward-Looking Statements
This release contains 'forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 'Forward-looking statements' describe future expectations, plans, results, or strategies and are generally preceded by words such as 'anticipates,' 'expect,' 'may,' 'plan' or 'will'. Forward-looking statements in this release include, but are not limited to, statements related to whether an unmet medical need exists for rezafungin; whether rezafungin will be approved for marketing in the US, the
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