What is the mechanism of action of this treatment?

The most common treatments for Aspergillosis, such as echinocandins (including Rezafungin), work by inhibiting the synthesis of β-(1,3)-D-glucan, an essential component of the fungal cell wall. This inhibition weakens the cell wall, leading to cell lysis and death of the fungus. This mechanism is crucial for Aspergillosis patients because it targets the structural integrity of the fungal cells, making it effective against invasive fungal infections that are difficult to treat and can be life-threatening, especially in immunocompromised individuals.

What side effects are associated with this type of intervention?

Common treatments for Aspergillosis that inhibit β-(1,3)-D-glucan synthesis, such as echinocandins (e.g., caspofungin, micafungin, anidulafungin), are generally well-tolerated. Known side effects include fever, phlebitis at the infusion site, elevated liver enzymes, and gastrointestinal symptoms like nausea and vomiting. Rarely, hypersensitivity reactions may occur. Rezafungin, a novel echinocandin, is expected to have a similar side effect profile, though unique adverse effects are still under investigation.

What prior FDA approvals exist?

Prior FDA approvals for the treatment of Aspergillosis include antifungal agents that inhibit β-(1,3)-D-glucan synthesis, such as echinocandins. Notable drugs in this class include Caspofungin, Micafungin, and Anidulafungin. These agents work by disrupting the fungal cell wall, leading to cell lysis and death. Rezafungin, currently under study, also targets β-(1,3)-D-glucan synthesis, offering a potential new option in this therapeutic category.

What other types of research exist?

Promising novel alternatives to Rezafungin for Aspergillosis patients include: 1) Ibrexafungerp, which also targets β-(1,3)-D-glucan synthesis and has shown efficacy in clinical trials. 2) Olorofim, a novel antifungal that inhibits dihydroorotate dehydrogenase, an enzyme involved in pyrimidine biosynthesis, offering a different mechanism of action. 3) Fosmanogepix, which targets the Gwt1 enzyme, crucial for fungal cell wall integrity. These alternatives are in advanced stages of clinical development and show potential for treating Aspergillosis.

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Echinocandin Antifungal

Rezafungin for Prevention of Fungal Infections (ReSPECT Trial)

Phase 3

Recruiting

Research Sponsored by Cidara Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with specific underlying diseases including acute myeloid leukemia (AML), acute lymphoblastic leukemia, acute undifferentiated leukemia, acute biphenotypic leukemia, chronic myelogenous leukemia, myelodysplastic syndrome, lymphoma, aplastic anemia, myelofibrosis, chronic myelomonocytic leukemia, chronic lymphocytic leukemia, drepanocytosis, red blood cell aplasia, myeloproliferative disorder, unclassified, and multiple myeloma

Receiving myeloablative or reduced-intensity conditioning regimens

Must not have

Diagnosis of chemotherapy-resistant lymphoma

Diagnosed symptomatic heart failure with specific criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 14 (±1 day), day 28 (±1 day), day 60 (±5 days), day 90 (±7 days), and day 120 (±7 days)

Awards & highlights

Pivotal Trial

Summary

This trial is testing if Rezafungin, given through an IV, is safe and effective in preventing serious fungal infections. It focuses on patients who have had blood and marrow transplants, as they are more likely to get these infections. Rezafungin works by stopping the growth of harmful fungi. It is designed for the treatment and prevention of invasive fungal infections with unique chemical stability.

Who is the study for?

Adults over 18 with certain blood diseases like leukemia or lymphoma, undergoing bone marrow transplants, can join this trial. They must have good kidney and liver function, agree to birth control measures if applicable, and not have had recent fungal infections or other specific health issues.

What is being tested?

The study is testing Rezafungin's effectiveness in preventing invasive fungal diseases during bone marrow transplantation compared to standard antifungal drugs like Posaconazole and Fluconazole.

What are the potential side effects?

Rezafungin may cause potential side effects such as allergic reactions, liver enzyme changes, gastrointestinal symptoms (nausea/vomiting), headache, infusion-related reactions, and possibly affect the heart rhythm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a specific blood-related disease.

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I am undergoing intense or moderate bone marrow preparation treatment.

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I agree to follow the required contraception measures.

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I am receiving a bone marrow transplant from a matched or partially matched donor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My lymphoma has not responded to chemotherapy.

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I have been diagnosed with heart failure that causes symptoms.

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My lung function is below normal levels.

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I am taking medication that could severely affect my nervous system.

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I am not taking any medication or supplement that badly interacts with standard infection treatments.

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I have had a bone marrow transplant from a donor.

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I have a severe movement disorder or nerve damage.

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I am HIV positive.

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My AML is not currently in remission.

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I experience significant unsteadiness, shaking, or numbness.

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I have or might have a fungal infection diagnosed in the last 4 weeks.

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I am scheduled for a stem cell transplant using my own cells.

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I am scheduled to receive a cord blood transplant.

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I have been diagnosed with liver cirrhosis.

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My body weight is over 130 kilograms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 14 (±1 day), day 28 (±1 day), day 60 (±5 days), day 90 (±7 days), and day 120 (±7 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 14 (±1 day), day 28 (±1 day), day 60 (±5 days), day 90 (±7 days), and day 120 (±7 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 14 (±1 day), day 28 (±1 day), day 60 (±5 days), day 90 (±7 days), and day 120 (±7 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Noninferior Fungal-Free Survival (US FDA)

Superior Fungal-Free Survival (EMA)

Secondary study objectives

Compare Discontinuation for Toxicity or Intolerance

Compare Fungal-Free Survival with or without a Diagnosis of Clinically Significant GVHD

Compare Mortality

+3 more

Other study objectives

Compare Antifungal Prophylaxis

Compare Incidence of IFD

Compare Infections Caused by TMP/SMX-Sensitive Organisms

+14 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group 1: Rezafungin for InjectionExperimental Treatment3 Interventions

Subjects in Rezafungin treatment group will receive a 400 mg loading dose in Week 1, followed by 200 mg once weekly, for a total of 13 weeks. Subjects will receive oral placebo for standard antimicrobial regimen (SAR) azole prophylaxis and oral placebo for SAR anti-Pneumocystis pneumonia (PCP) prophylaxis in accordance with the respective SAR dosing regimens for each. For subjects who are switched to a SAR IV regimen, oral placebo for SAR azole prophylaxis will be changed to IV placebo. There is no IV option for SAR anti-PCP prophylaxis.

Group II: Group 2: Oral AntifungalActive Control3 Interventions

Subjects randomized to the SAR will receive either fluconazole or posaconazole as the first-line SAR as per site's standard practice. Fluconazole will be administered orally at once daily doses of 400 mg for 13 weeks. Posaconazole will be administered orally as 300 mg twice daily on the first day and 300 mg once daily thereafter for 13 weeks. Azole-based antifungal therapy (fluconazole or posaconazole) can be switched from oral therapy to IV therapy if there is oral intolerance, at the discretion of the Investigator. Subjects who started on fluconazole SAR may be switched to posaconazole at the discretion of the Investigator if they develop acute clinically significant GVHD; In addition, subjects in the SAR group will receive anti PCP prophylaxis with oral TMP/SMX (80 mg TMP/ 400 mg SMX) once daily. There is no IV option for SAR anti-PCP prophylaxis.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oral Placebo

2017

Completed Phase 4

~4590

Rezafungin for Injection

2018

Completed Phase 3

~200

Intravenous Placebo

2016

Completed Phase 3

~2720

0 / 19Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Aspergillosis, such as echinocandins (including Rezafungin), work by inhibiting the synthesis of β-(1,3)-D-glucan, an essential component of the fungal cell wall. This inhibition weakens the cell wall, leading to cell lysis and death of the fungus. This mechanism is crucial for Aspergillosis patients because it targets the structural integrity of the fungal cells, making it effective against invasive fungal infections that are difficult to treat and can be life-threatening, especially in immunocompromised individuals.