Rezafugin Effective, Safe for the Treatment of Candidemia, Invasive Candidiasis: Presented at ASM Microbe

By Brian Hoyle

ATLANTA -- June 12, 2018 -- Rezafungin demonstrated safety and efficacy comparable to standard care in the treatment of Candidemia and invasive Candidiasis, according to a study presented here at ASM Microbe 2018.

The rezafungin 400 mg/200 mg once-weekly dosing regimen had the highest efficacy in all assessment.

“These results support the use of rezafungin for further clinical study in a phase 3 study,” reported George Thompson, MD, University of California at Davis, Sacramento, California, and colleagues.

The STRIVE trial evaluated the safety, tolerability, and efficacy of intravenously administered rezafungin in patients with candidemia or invasive candidiasis in North America and Europe. The 107 participants were randomised rezafungin 400 mg once weekly for up to 4 weeks (group 1; n = 35), rezafungin 400 mg followed by 200 mg once weekly for up to 4 weeks (group 2; n = 36), or, as a comparator, a daily injection of caspofungin (group 3; n = 28). The latter subjects could switch to oral fluconazole if they wished.

Overall success, defined as a clinical cure and lack of detection of the fungus at day 14 of treatment, was 58% in group 1, 71% in group 2, and 64% in group 3. The respective failure rates were 21%, 19%, and 29%. Clinical cure as assessed by the principal investigator was 76%, 77%, and 71%, respectively.

Thirty-day mortality rates were 15.2% in group 1, 3.2% % in group 2, and 10.7% in group 3. Treatment-emergent adverse events were evident in 87% of the patients in group 1, 94% in group 2, and 82% in group 3. Drug-related discontinuation involved 11%, 3%, and 3% of the patients in groups 1, 2, and 3, respectively. Serious adverse events occurred in 37%, 50%, and 39%, respectively.

“Overall, the safety and tolerability of rezafungin were similar to that of caspofungin,” the authors reported. “ Most patients experienced at least 1 treatment-emergent adverse event.”

There were 2 serious adverse events possibly related to the study drug.

STRIVE was not statistically powered to demonstrate superiority or non-inferiority.

Funding for this study was provided by Cidara Therapeutics.

ASM Microbe is the joint meeting of the American Society for Microbiology and the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).

[Presentation title: Clinical Efficacy and Safety of Rezafungin (CD101): Results From STRIVE, a Randomized, Double-blind, Multicenter, Phase 2 Study in the Treatment of Candidemia and/or Invasive Candidiasis. Abstract AARLB21]

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