Latest candidemia/invasive candidiasis research published in Clinical Infectious Diseases leading to drug approval
Benefit of rezafungin compared with caspofungin in patients with candidemia/invasive candidiasis
Read the full study published in Clinical Infectious Diseases here.
Background
Candidemia and invasive candidiasis are the most common fungal infections associated within healthcare settings, and are especially common among critically ill subjects. These infections are serious, with a mortality rate of around 40% after 30 days post-diagnosis [1-3].
Currently, the recommended therapy is daily intravenous echinocandins followed by oral azoles for several weeks depending on the site of infection and response to therapy [4]. The daily intravenous therapy is a challenge because it may prolong hospitalization or increase the complexity of outpatient therapy – availability of weekly echinocandin therapy in outpatient settings benefits patient access and adherence, improving their quality of life and decreasing hospital costs.
The availability of weekly echinocandin therapy helps patients to continue echinocandin therapy as outpatients, improving their quality and decreasing hospital costs.
Rezafungin, developed by Cidara Therapeutics, Inc., is the first echinocandin antifungal approved in more than 10 years and it is the first to be administrated intravenously “weekly” in contrast to previous echinocandins that are administered daily. PSI’s Director of Medical Monitoring for Infectious Diseases, Dr. Cecilia Dignani, co-authored the publication of a preplanned analysis of the phase 3 trial results in Clinical Infectious Diseases [5].
In short
The ReSTORE trial evaluated once-weekly rezafungin vs. intravenous daily caspofungin (the standard of care for candidemia) in patients aged ≥18 years with candidemia and/or invasive candidiasis. The primary results of the trial were published in the Lancet in 2023 [6]. Findings from the preplanned analysis of patients from the ReSTORE trial with a positive culture close to randomization suggested comparable efficacy and safety outcomes, with potential early clinical effects associated with rezafungin [5]:
Global cure
At Day 5, 55% (21/38) patients in the rezafungin group had a global cure response, compared with 43.5% (20/46) in the caspofungin group
At Day 14, 55% (21/38) patients in the rezafungin group had a global cure response, compared with 50% (23/46) in the caspofungin group
Mycological eradication
At Day 5, 71% (27/38) patients in the rezafungin group had mycological eradication, compared with 50% (23/46) in the caspofungin group
At Day 14, 63% (24/38) patients in the rezafungin group had mycological eradication, compared with 54% (25/46) in the caspofungin group
All-cause mortality
At Day 30, all-cause mortality was 26.3% (10/38) of patients in the rezafungin group, and 21.7% (10/46) patients in the caspofungin group
Safety
Most patients had ≥1 treatment-emergent adverse event during the course of the trial: 92.1% (35/38) patients in the rezafungin group, and 85% (39/46) patients in the caspofungin group
The potential impact of early eradication of candidemia, especially in patients without many other options for treatment, has important implications in preventing dissemination of Candida to other sites and reducing the likelihood of the emergence of resistance. The FDA and EMA agreed and approved rezafungin on the basis of the ReSTORE trial.
Cidara’s breakthrough treatment for candidemia and invasive candidiasis represents a huge step forward in the world of antifungals. Their drive and ambition led to the first new approval of an antifungal in ten years. I’m thrilled that so many patients will benefit now from this highly efficacious therapy that allows rapid resolution of the infection with a convenient weekly dosing. Not only in the hospital, but also in the outpatient setting, reducing burden to the patient, and to the healthcare system.
Footnote: In 2024, Cidara entered an asset purchase agreement with Mundipharma for the divestiture of rezafungin, allowing Mundipharma to continue to conduct further phase 3 trials, while Cidara is able to focus on its promising pipeline therapies.
Abbreviations
EMA, European Medicines Agency;
FDA, Food and Drug Administration
References
1. Schuster, S.J., et al., Loss of CD20 expression as a mechanism of resistance toSoriano, A., et al., Invasive candidiasis: current clinical challenges and unmet needs in adult populations. J Antimicrob Chemother, 2023. 78(7): p. 1569–1585. 2. Koehler, P., et al., Morbidity and mortality of candidaemia in Europe: an epidemiologic meta-analysis. Clin Microbiol Infect, 2019. 25(10): p. 1200–1212. 3. Hoenigl, M., et al., Guideline adherence and survival of patients with candidaemia in Europe: results from the ECMM Candida III multinational European observational cohort study. Lancet Infect Dis, 2023. 23(6): p. 751–761. 4. Cornely, O.A., et al., Global guideline for the diagnosis and management of candidiasis: an initiative of the ECMM in cooperation with ISHAM and ASM. Lancet Infect Dis, 2025. 25(5): p. e280–e293. 5 .Soriano, A., et al., Treatment Outcomes Among Patients With a Positive Candida Culture Close to Randomization Receiving Rezafungin or Caspofungin in the ReSTORE Study. Clin Infect Dis, 2024. 79(3): p. 672–681. 6. Thompson, G.R., 3rd, 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. 401(10370): p. 49–59.
Latest candidemia/invasive candidiasis research published in Clinical Infectious Diseases leading to drug approval
Benefit of rezafungin compared with caspofungin in patients with candidemia/invasive candidiasis
Read the full study published in Clinical Infectious Diseases here.
Background
Candidemia and invasive candidiasis are the most common fungal infections associated within healthcare settings, and are especially common among critically ill subjects. These infections are serious, with a mortality rate of around 40% after 30 days post-diagnosis [1-3].
Currently, the recommended therapy is daily intravenous echinocandins followed by oral azoles for several weeks depending on the site of infection and response to therapy [4]. The daily intravenous therapy is a challenge because it may prolong hospitalization or increase the complexity of outpatient therapy – availability of weekly echinocandin therapy in outpatient settings benefits patient access and adherence, improving their quality of life and decreasing hospital costs.
The availability of weekly echinocandin therapy helps patients to continue echinocandin therapy as outpatients, improving their quality and decreasing hospital costs.
Rezafungin, developed by Cidara Therapeutics, Inc., is the first echinocandin antifungal approved in more than 10 years and it is the first to be administrated intravenously “weekly” in contrast to previous echinocandins that are administered daily. PSI’s Director of Medical Monitoring for Infectious Diseases, Dr. Cecilia Dignani, co-authored the publication of a preplanned analysis of the phase 3 trial results in Clinical Infectious Diseases [5].
In short
The ReSTORE trial evaluated once-weekly rezafungin vs. intravenous daily caspofungin (the standard of care for candidemia) in patients aged ≥18 years with candidemia and/or invasive candidiasis. The primary results of the trial were published in the Lancet in 2023 [6]. Findings from the preplanned analysis of patients from the ReSTORE trial with a positive culture close to randomization suggested comparable efficacy and safety outcomes, with potential early clinical effects associated with rezafungin [5]:
The potential impact of early eradication of candidemia, especially in patients without many other options for treatment, has important implications in preventing dissemination of Candida to other sites and reducing the likelihood of the emergence of resistance. The FDA and EMA agreed and approved rezafungin on the basis of the ReSTORE trial.
Footnote: In 2024, Cidara entered an asset purchase agreement with Mundipharma for the divestiture of rezafungin, allowing Mundipharma to continue to conduct further phase 3 trials, while Cidara is able to focus on its promising pipeline therapies.
Abbreviations
EMA, European Medicines Agency;
FDA, Food and Drug Administration
References
1. Schuster, S.J., et al., Loss of CD20 expression as a mechanism of resistance toSoriano, A., et al., Invasive candidiasis: current clinical challenges and unmet needs in adult populations. J Antimicrob Chemother, 2023. 78(7): p. 1569–1585.
2. Koehler, P., et al., Morbidity and mortality of candidaemia in Europe: an epidemiologic meta-analysis. Clin Microbiol Infect, 2019. 25(10): p. 1200–1212.
3. Hoenigl, M., et al., Guideline adherence and survival of patients with candidaemia in Europe: results from the ECMM Candida III multinational European observational cohort study. Lancet Infect Dis, 2023. 23(6): p. 751–761.
4. Cornely, O.A., et al., Global guideline for the diagnosis and management of candidiasis: an initiative of the ECMM in cooperation with ISHAM and ASM. Lancet Infect Dis, 2025. 25(5): p. e280–e293.
5 .Soriano, A., et al., Treatment Outcomes Among Patients With a Positive Candida Culture Close to Randomization Receiving Rezafungin or Caspofungin in the ReSTORE Study. Clin Infect Dis, 2024. 79(3): p. 672–681.
6. Thompson, G.R., 3rd, 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. 401(10370): p. 49–59.
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