A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.

Last updated: May 13, 2025
Sponsor: Basilea Pharmaceutica
Overall Status: Active - Recruiting

Phase

3

Condition

Systemic Candidiasis

Vaginal Infection

Systemic Fungal Infections

Treatment

Caspofungin

PF-07842805

Fluconazole

Clinical Study ID

NCT05421858
FMGX-CS-301
2022-500455-23-00
2021-003656-16
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients ≥ 18 years (or the minimum country-specific age of consent if > 18) atScreening who have provided signed informed consent indicating that they understandthe purpose of, and procedures required for, the study, and are willing toparticipate in the study. If the patient is unable to consent for himself/herself, alegally authorized representative must provide informed consent on his/her behalf.

  2. Diagnosis of candidemia and/or invasive candidiasis based on a blood or non-bloodspecimen obtained within ≤ 96 hours (4 days) before randomization, and on clinicalcriteria judged attributable to candidemia/invasive candidiasis occurring at anytime from ≤ 12 hours prior to the qualifying positive index culture being takenthrough to randomization.

  3. Patient's condition allows for appropriate infection source control measures,including removal of pre-existing intravascular catheters and devices, if necessary.

Exclusion

Exclusion Criteria:

  1. Existing infection

  2. Infection known to be due to Candida krusei, in blood or any other normallysterile site.

  3. Inappropriate fungal infection source control.

  4. Diagnosis of certain deep-seated Candida infections.

  5. Life expectancy of < 72 hours in the opinion of the investigator.

  6. Requirement, or expected requirement, for hemodialysis, peritoneal dialysis, orhemofiltration.

  7. Ongoing neurological disorders, including specified conditions presenting with aCTCAE Grade ≥ 2 (neurological symptoms that are considered to be a consequence ofthe current episode of candidemia / invasive candidiasis are not exclusionary).

  8. Patients with known human immunodeficiency virus infection, who have CD4+ count < 200/mm3 or viral load > 400 copies/mL), or who have had an active opportunisticinfection within 6 months prior to Screening.

  9. Other medical or psychiatric condition or laboratory abnormality that may increasethe risk of study participation or make the patient inappropriate for the study.

  10. Current use of any prohibited concomitant medications or those unwilling/unable touse a permitted concomitant medication.

  11. Received > 2 days (> 48 hours) equivalent of prior systemic antifungal treatment atapproved doses and frequency to treat the current episode of candidemia and/orinvasive candidiasis (e.g., > 2 doses of a once daily antifungal agent or > 4 dosesof a twice daily antifungal agent), within the 96 hours prior to randomization (except for non-susceptible Candida spp. and for patients who develop candidemia orinvasive candidiasis while on prophylaxis with an azole or amphotericin B).

  12. Previous administration with an investigational drug or investigational vaccinewithin 30 days or 5 half-lives preceding the first dose of study drug used in thisstudy (whichever is longer).

  13. Prior participation in this or any previous study of fosmanogepix.

  14. Moderate or severe hepatic impairment, known active viral hepatitis B or C, ALT orAST ≥ 5 × ULN or total bilirubin > 3 × ULN unless this is due to isolatedhyperbilirubinemia or documented Gilbert's syndrome.

  15. Female patient is pregnant or lactating.

  16. Known hypersensitivity to fosmanogepix, manogepix, caspofungin, any echinocandin,fluconazole or to any of their excipients.

  17. Investigator site staff directly involved in the conduct of the study and theirfamily members, site staff otherwise supervised by the investigator, and Sponsor andSponsor delegate employees directly involved in the conduct of the study and theirfamily members.

Study Design

Total Participants: 450
Treatment Group(s): 5
Primary Treatment: Caspofungin
Phase: 3
Study Start date:
December 11, 2024
Estimated Completion Date:
January 30, 2028

Connect with a study center

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Monash Medical Center Clayton

    Clayton, 3168
    Australia

    Active - Recruiting

  • Kepler University Hospital GmbH, Department of Pulmonology, Clinical Department of Infectious Diseases

    Linz, 4021
    Austria

    Active - Recruiting

  • Hospital Favoriten, Department of Internal Medicine IV - Infectious Diseases and Tropical Medicine

    Vienna, 1100
    Austria

    Active - Recruiting

  • Medical University Vienna

    Vienna, 1090
    Austria

    Active - Recruiting

  • General Hospital Saint-Jan

    Brugge, 8000
    Belgium

    Active - Recruiting

  • Erasme Hospital, Department of Infectious and Tropical Diseases

    Brussels, B-1070
    Belgium

    Active - Recruiting

  • Saint Luc University Hospital, Department of Internal Medicine

    Brussels, 1200
    Belgium

    Active - Recruiting

  • University Hospital Brussels

    Brussels, 1090
    Belgium

    Active - Recruiting

  • Jessa Hospital

    Hasselt, 3500
    Belgium

    Active - Recruiting

  • University Hospitals Leuven, Campus Gasthuisberg, Department of Infectious Diseases

    Leuven, 3000
    Belgium

    Active - Recruiting

  • UCL Mont-Godinne University Hospitals

    Yvoir, 5530
    Belgium

    Active - Recruiting

  • Eurohospital University Hospital

    Plovdiv, 4004
    Bulgaria

    Active - Recruiting

  • University Medical Center "N. I. Pirogov"

    Sofia, 1606
    Bulgaria

    Site Not Available

  • University Medical Center "N. I. Pirogov", Burns and Plastic Surgery Clinic

    Sofia, 1606
    Bulgaria

    Active - Recruiting

  • University Medical Center "N. I. Pirogov", Clinic of Purulent-Septic Surgery

    Sofia, 1606
    Bulgaria

    Active - Recruiting

  • Amiens Picardie University Hospital - South, Intensive Care Unit (ICU)

    Amiens, 80054
    France

    Active - Recruiting

  • Victor Dupouy Hospital Center Argenteuil, Intensive Care Unit

    Argenteuil, 95107
    France

    Active - Recruiting

  • Nantes University Hospital Center - Hotel Dieu Hospital, Department of Infectious and Tropical Diseases

    Nantes, 44000
    France

    Active - Recruiting

  • Tours Regional University Hospital Center

    Tours, 37000
    France

    Active - Recruiting

  • University Hospital Ulm, Comprehensive Infectious Diseases Center Ulm (CIDCU)

    Ulm, Baden-Wuerttemberg 89081
    Germany

    Active - Recruiting

  • University Hospital Cologne, Department of Internal Medicine I, Clinical Study Centre II for Infectious Diseases

    Cologne, North Rhine-Westphalia 50937
    Germany

    Active - Recruiting

  • University Hospital Heidelberg, Clinic for Anesthesiology

    Heidelberg, 69120
    Germany

    Active - Recruiting

  • "LAIKO" General Hospital

    Athens, 115 27
    Greece

    Active - Recruiting

  • "Sotiria" Chest Diseases Hospital of Athens

    Athens, 11527
    Greece

    Active - Recruiting

  • General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit

    Athens, PC 10676
    Greece

    Active - Recruiting

  • Tzaneio General Hospital

    Piraeus, 185 36
    Greece

    Active - Recruiting

  • General Hospital of Thessaloniki "Ippokratio"

    Thessaloniki, 54642
    Greece

    Active - Recruiting

  • Rambam Health Care Campus, Institute of Infectious Diseases

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Edith Wolfson Medical Center, Department of Infectious Diseases

    Holon, 58100
    Israel

    Active - Recruiting

  • Chaim Sheba Medical Center, Department of Infectious Diseases

    Ramat Gan, 52621
    Israel

    Active - Recruiting

  • The Tel Aviv Sourasky Medical Center, Infectious Diseases Unit

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

  • Shamir Medical Center, Department of Infectious Diseases

    Zerifin, 7033001
    Israel

    Active - Recruiting

  • Hospital "S. Croce e Carle"

    Cuneo, 12100
    Italy

    Active - Recruiting

  • IRCCS Policlinic Hospital San Martino

    Genoa, 16132
    Italy

    Active - Recruiting

  • Hospital San Raffaele, IRCCS

    Milan, 20132
    Italy

    Active - Recruiting

  • Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda

    Milan, 20122
    Italy

    Active - Recruiting

  • Polyclinic San Matteo, IRCCS

    Pavia, 27100
    Italy

    Active - Recruiting

  • University Hospital of Pisa

    Pisa, 56124
    Italy

    Active - Recruiting

  • Giuliano Isontina University Health Authority

    Trieste, 34125
    Italy

    Active - Recruiting

  • Kyungpook National University Hospital

    Daegu, 41944
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Ajou University Hospital

    Suwon, 16499
    Korea, Republic of

    Active - Recruiting

  • Ryexo Clinical Research

    Pretoria, 0084
    South Africa

    Active - Recruiting

  • University of Pretoria / Steve Biko Academic Hospital

    Pretoria, 0084
    South Africa

    Active - Recruiting

  • Practice of R Moodley and MI Sarvan - Umhlanga

    Umhlanga, 4320
    South Africa

    Active - Recruiting

  • University Hospital Nuestra Senora de Valme

    Seville, Andalusia 41014
    Spain

    Active - Recruiting

  • University Hospital Virgen Macarena

    Seville, Andalusia 41009
    Spain

    Active - Recruiting

  • Hospital Clinic of Barcelona, Department of Infectious Diseases

    Barcelona, Catalonia 08036
    Spain

    Active - Recruiting

  • Hospital del Mar, Department of Infectious Diseases

    Barcelona, Catalonia 08003
    Spain

    Active - Recruiting

  • University Hospital Ramon y Cajal, Department of Infectious Diseases

    Madrid, Community Of Madrid 28034
    Spain

    Active - Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, 807377
    Taiwan

    Active - Recruiting

  • Far Eastern Memorial Hospital

    New Taipei City, 220
    Taiwan

    Active - Recruiting

  • China Medical University Hospital

    Taichung, 404327
    Taiwan

    Active - Recruiting

  • Taichung Veterans General Hospital

    Taichung, 407219
    Taiwan

    Active - Recruiting

  • Taipei Medical University Hospital

    Taipei, 11000
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei, 112201
    Taiwan

    Active - Recruiting

  • Linkou Chang Gung Memorial Hospital

    Taoyuan City, 333
    Taiwan

    Active - Recruiting

  • Siriraj Hospital

    Bangkok, 10700
    Thailand

    Active - Recruiting

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200
    Thailand

    Active - Recruiting

  • Songklanagarind Hospital

    Hat Yai, 90110
    Thailand

    Active - Recruiting

  • UC Davis Medical Center

    Sacramento, California 95817
    United States

    Active - Recruiting

  • Emory University Hospital - Clifton Road

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Indiana University Methodist Hospital

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • University of Kentucky College of Medicine

    Lexington, Kentucky 40506
    United States

    Active - Recruiting

  • Henry Ford Hospital, Department of Medicine, Division of Infectious Diseases

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Washington University School of Medicine, Infectious Diseases Clinical Research Unit

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

  • Houston Methodist Hospital - Texas Medical Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

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