450 Participants Needed

Fosmanogepix for Candida Blood Infection

Recruiting at 80 trial locations
PC
MH
ME
Overseen ByMarc Engelhardt, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Fosmanogepix) for the potential treatment of candidemia and/or invasive candidiasis, a life-threatening fungal infection caused by several species of yeast called Candida.The study is seeking patients who have a diagnosis of candidemia and/or invasive candidiasis.Two-thirds of all patients will receive the study medication fosmanogepix Intravenous (IV) infusion followed by optional fosmanogepix tablets. One-third of all patients will receive a standard of care regimen of caspofungin Intravenous (IV) infusion followed by optional fluconazole capsules.Fosmanogepix or caspofungin will first be given as an Intravenous (IV) infusion directly into a vein in the arm each day at the study clinic. Fosmanogepix tablets or fluconazole capsules will be taken orally by mouth daily either at the study clinic, or at home if patients are well enough to be discharged from the hospital.The treatment effect in patients receiving fosmanogepix to those receiving caspofungin/ fluconazole will be compared. The primary aim is to show that fosmanogepix is not inferior (not worse) to caspofungin/ fluconazole with a noninferiority margin of 15%.The duration of study treatment and number of study visits will vary depending on how long the patient will be treated for the infection. Treatment will continue for a maximum of 6 weeks depending on when the infection is cleared and whether other symptoms related to the infection have improved. There will also be a follow-up visit 6 weeks after the study treatment was stopped.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you cannot use any prohibited medications during the study. It's best to discuss your current medications with the study team to see if they are allowed.

Is Fosmanogepix safe for human use?

Fosmanogepix has been shown to be safe and well-tolerated in clinical trials, with no treatment-related adverse events reported in patients with candidemia (a type of blood infection) caused by Candida auris. It has been tested in both intravenous and oral forms, and participants in these studies did not experience significant safety issues.12345

What makes the drug Fosmanogepix unique for treating Candida blood infections?

Fosmanogepix is unique because it has a novel mechanism of action that targets the fungal cell wall, which is different from traditional antifungal drugs like azoles and echinocandins. This makes it potentially effective against Candida strains that have developed resistance to other treatments.678910

What data supports the effectiveness of the drug Fosmanogepix for treating Candida blood infections?

Research shows that Fosmanogepix is effective in treating Candida blood infections, with a study reporting an 89% success rate in clearing the infection without additional antifungals. It is also well-tolerated and has broad-spectrum activity against various fungi, including those resistant to standard treatments.123411

Who Is on the Research Team?

MH

Manuel Häckl, MD

Principal Investigator

Basilea Pharmaceutica International Ltd, Allschwil

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with candidemia or invasive candidiasis who understand the study and agree to participate. They must have had a diagnosis within 4 days before joining the trial and be able to undergo necessary procedures like removing catheters if needed.

Inclusion Criteria

I have been diagnosed with a Candida infection in my blood or other parts of my body within the last 4 days.
I can undergo procedures to control infection, including removing any catheters if needed.

Exclusion Criteria

I am currently pregnant or breastfeeding.
Prior participation in this or any previous study of fosmanogepix.
I am allergic to fosmanogepix, manogepix, caspofungin, echinocandins, fluconazole, or their ingredients.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either fosmanogepix or caspofungin as an IV infusion, with an option to switch to oral tablets or capsules

Up to 6 weeks
Daily visits for IV infusion, with potential for home administration of oral medication

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks
1 follow-up visit

What Are the Treatments Tested in This Trial?

Interventions

  • PF-07842805
Trial Overview The trial tests Fosmanogepix, comparing it against standard treatments Caspofungin/Fluconazole for fungal infections caused by Candida. Patients will receive either IV infusions followed by oral tablets of the study drug or standard care, aiming to prove Fosmanogepix is at least as effective.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Fosmanogepix IV/oralExperimental Treatment2 Interventions
Group II: Caspofungin IV/ Fluconazole oralActive Control3 Interventions

PF-07842805 is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Fosmanogepix for:
🇪🇺
Approved in European Union as Fosmanogepix for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Basilea Pharmaceutica

Lead Sponsor

Trials
53
Recruited
9,900+

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Biomedical Advanced Research and Development Authority

Collaborator

Trials
108
Recruited
574,000+

Published Research Related to This Trial

Fosmanogepix, an antifungal prodrug, was found to be safe and well tolerated in a Phase 1b study involving 21 adult patients with acute myeloid leukemia (AML) and neutropenia, with no serious adverse events leading to discontinuation.
The pharmacokinetics of fosmanogepix were comparable to previous studies in healthy volunteers, indicating consistent absorption and elimination, which supports its potential use in treating invasive fungal diseases during chemotherapy.
Phase 1b safety and pharmacokinetics of intravenous and oral fosmanogepix in patients with acute myeloid leukaemia and neutropenia.Cornely, OA., Ostermann, H., Koehler, P., et al.[2023]
Fosmanogepix (FMGX) demonstrated a high treatment success rate of 89% in a study of 9 participants with candidemia caused by Candida auris, indicating its efficacy against this resistant fungal infection.
The treatment was well-tolerated with no reported adverse events, suggesting that FMGX is a safe option for patients with limited antifungal treatment alternatives.
Clinical Efficacy and Safety of a Novel Antifungal, Fosmanogepix, in Patients with Candidemia Caused by Candida auris: Results from a Phase 2 Trial.Vazquez, JA., Pappas, PG., Boffard, K., et al.[2023]
Fosmanogepix, currently in Phase 2 trials, is a promising antifungal that effectively targets invasive fungal infections caused by Candida, Aspergillus, and other rare molds, showing significant in vivo efficacy in various animal models.
Its unique mechanism of action allows it to remain effective against resistant strains of fungi, and it has high oral bioavailability (>90%), making it easy to switch between intravenous and oral forms without losing effectiveness.
Fosmanogepix: A Review of the First-in-Class Broad Spectrum Agent for the Treatment of Invasive Fungal Infections.Shaw, KJ., Ibrahim, AS.[2021]

Citations

Phase 1b safety and pharmacokinetics of intravenous and oral fosmanogepix in patients with acute myeloid leukaemia and neutropenia. [2023]
Clinical Efficacy and Safety of a Novel Antifungal, Fosmanogepix, in Patients with Candidemia Caused by Candida auris: Results from a Phase 2 Trial. [2023]
Fosmanogepix: A Review of the First-in-Class Broad Spectrum Agent for the Treatment of Invasive Fungal Infections. [2021]
Clinical safety and efficacy of novel antifungal, fosmanogepix, for the treatment of candidaemia: results from a Phase 2 trial. [2023]
Antimicrobial activity of manogepix, a first-in-class antifungal, and comparator agents tested against contemporary invasive fungal isolates from an international surveillance programme (2018-2019). [2021]
Manogepix (APX001A) Displays Potent In Vitro Activity against Human Pathogenic Yeast, but with an Unexpected Correlation to Fluconazole MICs. [2021]
Efficient Recovery of Candida auris and Five Other Medically Important Candida Species from Blood Cultures Containing Clinically Relevant Concentrations of Antifungal Agents. [2023]
Candida osteomyelitis as a complication of parenteral nutrition in an infant. Successful treatment with flucytosine. [2013]
[Restropective investigation about the treatment of candidaemia in a French university hospital in 2004]. [2020]
Aetiology and antifungal susceptibility of yeast bloodstream infections in a Hungarian university hospital between 1996 and 2000. [2020]
The identification of Meyerozyma guilliermondii from blood cultures and surveillance samples in a university hospital in Northeast Turkey: A ten-year survey. [2022]
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