RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Basilea Pharmaceutica • ClinicalTrials.gov ID: NCT05421858

Registry updated: 2026-10-19

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Description

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.

Interventions

Fosmanogepix (Drug)
IV infusion
Fosmanogepix (Drug)
Oral tablet
Caspofungin (Drug)
IV infusion
Fluconazole (Drug)
Fluconazole oral capsule
Placebo (Drug)
Matching placebo for caspofungin (IV infusion)
Placebo (Drug)
Matching placebo for fluconazole (oral capsule)
Placebo (Drug)
Matching placebo for fosmanogepix (IV infusion)
Placebo (Drug)
Matching placebo for fosmanogepix (oral tablet)

Eligibility criteria

Inclusion Criteria: 1. Patients ≥ 18 years (or the minimum country-specific age of consent if \> 18) at Screening who have provided signed informed consent indicating that they understand the purpose of, and procedures required for, the study, and are willing to participate in the study. If the patient is unable to consent for himself/herself, a legally authorized representative must provide informed consent on his/her behalf. 2. Diagnosis of candidemia and/or invasive candidiasis based on a blood or non-blood specimen obtained within ≤ 96 hours (4 days) before randomization, and on clinical criteria judged attributable to candidemia/invasive candidiasis occurring at any time from ≤ 12 hours prior to the qualifying positive index culture being taken through 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 Criteria: 1. Existing infection 1. Infection known to be due to Candida krusei, in blood or any other normally sterile site. 2. Inappropriate fungal infection source control. 3. Diagnosis of certain deep-seated Candida infections. 2. Life expectancy of \< 72 hours in the opinion of the investigator. 3. Requirement, or expected requirement, for hemodialysis, peritoneal dialysis, or hemofiltration. 4. Ongoing neurological disorders, including specified conditions presenting with a CTCAE Grade ≥ 2 (neurological symptoms that are considered to be a consequence of the current episode of candidemia / invasive candidiasis are not exclusionary). 5. 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 opportunistic infection within 6 months prior to Screening. 6. Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or make the patient inappropriate for the study. 7. Current use of any prohibited concomitant medications or those unwilling/unable to use a permitted concomitant medication. 8. Received \> 2 days (\> 48 hours) equivalent of prior systemic antifungal treatment at approved doses and frequency to treat the current episode of candidemia and/or invasive candidiasis (e.g., \> 2 doses of a once daily antifungal agent or \> 4 doses of a twice daily antifungal agent), within the 96 hours prior to randomization (except for non-susceptible Candida spp. and for patients who develop candidemia or invasive candidiasis while on prophylaxis with an azole or amphotericin B). 9. Previous administration with an investigational drug or investigational vaccine within 30 days or 5 half-lives preceding the first dose of study drug used in this study (whichever is longer). 10. Prior participation in this or any previous study of fosmanogepix. 11. Moderate or severe hepatic impairment, known active viral hepatitis B or C, ALT or AST ≥ 5 × ULN or total bilirubin \> 3 × ULN unless this is due to isolated hyperbilirubinemia or documented Gilbert's syndrome. 12. Female patient is pregnant or lactating. 13. Known hypersensitivity to fosmanogepix, manogepix, caspofungin, any echinocandin, fluconazole or to any of their excipients. 14. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and Sponsor and Sponsor delegate employees directly involved in the conduct of the study and their family members.

Conditions

Candidemia Candidiasis, Invasive

Locations

University of Alabama at Birmingham School of Medicine, Department of Medicine — Birmingham, Alabama, United States
City of Hope — Duarte, California, United States
David Geffen School of Medicine at UCLA — Los Angeles, California, United States
UC Davis Medical Center — Sacramento, California, United States
Emory University Hospital - Clifton Road — Atlanta, Georgia, United States
Augusta University Medical Center — Augusta, Georgia, United States
Indiana University Methodist Hospital — Indianapolis, Indiana, United States
University of Kentucky College of Medicine — Lexington, Kentucky, United States
Johns Hopkins Hospital — Baltimore, Maryland, United States
University of Michigan Health System (UMHS) - A. Alfred Taubman Health Care Center — Ann Arbor, Michigan, United States
DMC Harper University Hospital — Detroit, Michigan, United States
Henry Ford Hospital, Department of Medicine, Division of Infectious Diseases — Detroit, Michigan, United States
University of Minnesota — Minneapolis, Minnesota, United States
Washington University School of Medicine, Infectious Diseases Clinical Research Unit — St Louis, Missouri, United States
Weill Cornell Medical College - NewYork-Presbyterian Hospital — New York, New York, United States
University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
University of Pennsylvania School of Medicine — Philadelphia, Pennsylvania, United States
UPMC Presbyterian — Pittsburgh, Pennsylvania, United States
Houston Methodist Hospital - Texas Medical Center — Houston, Texas, United States
The University of Texas Health Science Center at Houston — Houston, Texas, United States
U.T. MD Anderson Cancer Center — Houston, Texas, United States
University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
Carilion Clinic — Roanoke, Virginia, United States
Central Hospital de San Isidro Melchor Posse — Buenos Aires, Argentina
Buenos Aires Italian Hospital, Department of Infectious Diseases — Buenos Aires, Argentina
Cordoba Private University Hospital, Department of Infectious Diseases — Córdoba, Argentina
Italian Hospital of La Plata, Department of Infectious Diseases — La Plata, Argentina
Central Hospital Mendoza — Mendoza, Argentina
British Sanatorium SA — Rosario, Argentina
Westmead Hospital — Sydney, New South Wales, Australia
Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
Peter MacCallum Cancer Center, State — Melbourne, Victoria, Australia
The Alfred Hospital — Melbourne, Victoria, Australia
Royal Melbourne Hospital — Parkville, Victoria, Australia
Monash Medical Center Clayton — Clayton, Australia
University Hospital Graz, Department of Internal Medicine — Graz, Austria
Kepler University Hospital GmbH, Department of Pulmonology, Clinical Department of Infectious Diseases — Linz, Austria
Medical University Vienna — Vienna, Austria
Hospital Favoriten, Department of Internal Medicine IV - Infectious Diseases and Tropical Medicine — Vienna, Austria
General Hospital Saint-Jan — Bruges, Belgium
University Hospital Brussels — Brussels, Belgium
Saint Luc University Hospital, Department of Internal Medicine — Brussels, Belgium
Erasme Hospital, Department of Infectious and Tropical Diseases — Brussels, Belgium
Jessa Hospital — Hasselt, Belgium
University Hospitals Leuven, Campus Gasthuisberg, Department of Infectious Diseases — Leuven, Belgium
UCL Mont-Godinne University Hospitals — Yvoir, Belgium
HC-UFPR — Curitiba, Paraná, Brazil
Hospital Our Lady of Grace — Curitiba, Paraná, Brazil
Porto Alegre Clinical Hospital (HCPA), Infectious Diseases / Internal Medicine — Porto Alegre, Rio Grande do Sul, Brazil
Pontifical University Of Rio Grande Do Sul (PUCRS) - St. Luke Hospital — Porto Alegre, Rio Grande do Sul, Brazil
Santa Marcelina Hospital — São Paulo, São Paulo, Brazil
Eurohospital University Hospital — Plovdiv, Bulgaria
University Medical Center "N. I. Pirogov", Burns and Plastic Surgery Clinic — Sofia, Bulgaria
University Medical Center "N. I. Pirogov", Clinic of Purulent-Septic Surgery — Sofia, Bulgaria
China-Japan Friendship Hospital — Beijing, China
The First Affiliated Hospital of Bengbu Medical College — Bengbu, China
West China Hospital, Sichuan University — Chengdu, China
The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, China
Guangzhou First People's Hospital — Guangzhou, China
The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, China
Zhejiang Provincal Hospital of Chinese Medicine — Hangzhou, China
Zhejiang Provincial People's Hospital — Hangzhou, China
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine — Hangzhou, China
Lishui People's Hospital — Lishui, China
Liuzhou People's Hospital — Liuzhou, China
The 1st Affiliated Hospital of Nanchang University — Nanchang, China
Qingyuan People's Hospital — Qingyuan, China
Huashan Hospital — Shanghai, China
Shenzhen Third People's Hospital — Shenzhen, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences — Tianjin, China
Central Hospital of Wuhan — Wuhan, China
Zhongnan Hospital of Wuhan University — Wuhan, China
Wuxi People's Hospital — Wuxi, China
The First Affiliated Hospital of Henan University of Science and Technology — Zhengzhou, China
Cardiomet CEQUIN Foundation, Department of Nephrology — Armenia, Colombia
Hospital Alma Mater de Antioquia — Medellín, Colombia
Luz Castro de Gutierrez Medellin General Hospital, Research Center — Medellín, Colombia
Pablo Tobon Uribe Hospital — Medellín, Colombia
High Technology Medical Institute S.A.S, IMAT S.A.S. — Montería, Colombia
Somer Clinic — Rionegro, Colombia
Amiens Picardie University Hospital - South, Intensive Care Unit (ICU) — Amiens, France
Victor Dupouy Hospital Center Argenteuil, Intensive Care Unit — Argenteuil, France
Marseille Nord University Hospitals - AP-HM, Medical Intensive Care Unit, Acute Respiratory Distress and Severe Infections — Marseille, France
Nantes University Hospital Center - Hotel Dieu Hospital, Department of Infectious and Tropical Diseases — Nantes, France
Rennes University Hospital Center - Hospital Pontchaillou — Rennes, France
Tours Regional University Hospital Center — Tours, France
University Hospital Ulm, Comprehensive Infectious Diseases Center Ulm (CIDCU) — Ulm, Baden-Wurttemberg, Germany
University Hospital Regensburg — Regensburg, Bavaria, Germany
Frankfurt University Clinic — Frankfurt am Main, Hesse, Germany
University Hospital Giessen and Marburg GmbH — Giessen, Hesse, Germany
University Hospital Cologne, Department of Internal Medicine I, Clinical Study Centre II for Infectious Diseases — Cologne, North Rhine-Westphalia, Germany
University Hospital Heidelberg, Clinic for Anesthesiology — Heidelberg, Germany
"LAIKO" General Hospital — Athens, Greece
"Sotiria" Chest Diseases Hospital of Athens — Athens, Greece
General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit — Athens, Greece
University General Hospital of Heraklion — Heraklion, Greece
Tzaneio General Hospital — Piraeus, Greece
General Hospital of Thessaloniki "Ippokratio" — Thessaloniki, Greece
Rambam Health Care Campus, Institute of Infectious Diseases — Haifa, Israel
Edith Wolfson Medical Center, Department of Infectious Diseases — Holon, Israel
Chaim Sheba Medical Center, Department of Infectious Diseases — Ramat Gan, Israel
The Tel Aviv Sourasky Medical Center, Infectious Diseases Unit — Tel Aviv, Israel
Shamir Medical Center, Department of Infectious Diseases — Ẕerifin, Israel
Hospital "S. Croce e Carle" — Cuneo, Italy
IRCCS Policlinic Hospital San Martino — Genoa, Italy
Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda — Milan, Italy
Hospital San Raffaele, IRCCS — Milan, Italy
Big Metropolitan Hospital Niguarda Regional Health Authority — Milan, Italy
University Polyclinic Hospital of Modena — Modena, Italy
Polyclinic San Matteo, IRCCS — Pavia, Italy
University Hospital of Pisa — Pisa, Italy
AOU Senese — Siena, Italy
Giuliano Isontina University Health Authority — Trieste, Italy
National University Hospital — Singapore, Singapore
Singapore General Hospital — Singapore, Singapore
Tan Tock Seng Hospital — Singapore, Singapore
Helen Joseph Hospital — Johannesburg, South Africa
Milpark Hospital — Johannesburg, South Africa
Ryexo Clinical Research — Pretoria, South Africa
University of Pretoria / Steve Biko Academic Hospital — Pretoria, South Africa
Practice of R Moodley and MI Sarvan - Umhlanga — Umhlanga, South Africa
Kyungpook National University Hospital — Daegu, South Korea
Severance Hospital, Yonsei University Health System — Seoul, South Korea
Samsung Medical Center — Seoul, South Korea
Ajou University Hospital — Suwon, South Korea
University Hospital Virgen Macarena — Seville, Andalusia, Spain
University Hospital Nuestra Senora de Valme — Seville, Andalusia, Spain
Hospital del Mar, Department of Infectious Diseases — Barcelona, Catalonia, Spain
University Hospital Vall d'Hebron, Intensive Care Unit (ICU) — Barcelona, Catalonia, Spain
Hospital Clinic of Barcelona, Department of Infectious Diseases — Barcelona, Catalonia, Spain
University Hospital Ramon y Cajal, Department of Infectious Diseases — Madrid, Madrid, Spain
University Hospital Cruces — Barakaldo, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan
Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan
Far Eastern Memorial Hospital — New Taipei City, Taiwan
China Medical University Hospital — Taichung, Taiwan
Taichung Veterans General Hospital — Taichung, Taiwan
National Taiwan University Hospital — Taipei, Taiwan
Taipei Medical University Hospital — Taipei, Taiwan
Taipei Veterans General Hospital — Taipei, Taiwan
Linkou Chang Gung Memorial Hospital — Taoyuan City, Taiwan
Vajira Hospital — Bangkok, Thailand
Siriraj Hospital — Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital — Chiang Mai, Thailand
Songklanagarind Hospital — Hat Yai, Thailand
Srinagarind Hospital — Khon Kaen, Thailand

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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