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

An Interventional Efficacy and Safety Phase 3 Double-blind 2-arm Study to Investigate IV Followed by Oral Fosmanogepix Compared With IV Caspofungin Followed by Oral Fluconazole in Adult Participants With Candidemia and/or Invasive Candidiasis

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.

Study Overview

• Status: Recruiting
• Conditions: Candidemia; Candidiasis, Invasive
• Intervention / Treatment: Drug: Fluconazole; Drug: Fosmanogepix; Drug: Fosmanogepix; Drug: Placebo; Drug: Placebo; Drug: Placebo; Drug: Placebo; Drug: Caspofungin

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

• Study Contact: Name: Manuel Häckl, MD; Phone Number: +41 76 302 53 10; Email: manuel.haeckl@basilea.com
• Study Contact Backup: Name: Marc Engelhardt, MD; Phone Number: +41 79 701 0551; Email: marc.engelhardt@basilea.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1199ABB
    • Recruiting
    • Buenos Aires Italian Hospital, Department of Infectious Diseases
  • Buenos Aires, Argentina, B1641
    • Recruiting
    • Central Hospital de San Isidro Melchor Posse
  • Córdoba, Argentina, X5016KEH
    • Recruiting
    • Cordoba Private University Hospital, Department of Infectious Diseases
  • La Plata, Argentina, B1900
    • Recruiting
    • Italian Hospital of La Plata, Department of Infectious Diseases
  • Mendoza, Argentina, M5500IDN
    • Recruiting
    • Central Hospital Mendoza
  • Rosario, Argentina, S2000CVB
    • Recruiting
    • British Sanatorium SA
• Australia
  • Clayton, Australia, 3168
    • Recruiting
    • Monash Medical Center Clayton
  • New South Wales
    • Sydney, New South Wales, Australia, 2145
      • Recruiting
      • Westmead Hospital
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Recruiting
      • Princess Alexandra Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Recruiting
      • The Alfred Hospital
    • Melbourne, Victoria, Australia, 3000
      • Recruiting
      • Peter MacCallum Cancer Center, State
    • Parkville, Victoria, Australia, 3050
      • Recruiting
      • Royal Melbourne Hospital
• Austria
  • Graz, Austria, 1100
    • Recruiting
    • University Hospital Graz, Department of Internal Medicine
  • Linz, Austria, 4021
    • Recruiting
    • Kepler University Hospital GmbH, Department of Pulmonology, Clinical Department of Infectious Diseases
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University Vienna
  • Vienna, Austria, 1100
    • Recruiting
    • Hospital Favoriten, Department of Internal Medicine IV - Infectious Diseases and Tropical Medicine
• Belgium
  • Bruges, Belgium, 8000
    • Recruiting
    • General Hospital Saint-Jan
  • Brussels, Belgium, 1090
    • Recruiting
    • University Hospital Brussels
  • Brussels, Belgium, 1200
    • Recruiting
    • Saint Luc University Hospital, Department of Internal Medicine
  • Brussels, Belgium, B-1070
    • Recruiting
    • Erasme Hospital, Department of Infectious and Tropical Diseases
  • Hasselt, Belgium, 3500
    • Recruiting
    • Jessa Hospital
  • Leuven, Belgium, 3000
    • Recruiting
    • University Hospitals Leuven, Campus Gasthuisberg, Department of Infectious Diseases
  • Yvoir, Belgium, 5530
    • Suspended
    • UCL Mont-Godinne University Hospitals
• Brazil
  • São Paulo, Brazil, 08270-070
    • Recruiting
    • Santa Marcelina Hospital
  • Paraná
    • Curitiba, Paraná, Brazil, 80810-040
      • Recruiting
      • Hospital Our Lady of Grace
    • Curitiba, Paraná, Brazil, 80060-900
      • Recruiting
      • HC-UFPR
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
      • Recruiting
      • Porto Alegre Clinical Hospital (HCPA), Infectious Diseases / Internal Medicine
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Recruiting
      • Pontifical University Of Rio Grande Do Sul (PUCRS) - St. Luke Hospital
• Bulgaria
  • Plovdiv, Bulgaria, 4004
    • Recruiting
    • Eurohospital University Hospital
  • Sofia, Bulgaria, 1606
    • Recruiting
    • University Medical Center "N. I. Pirogov", Burns and Plastic Surgery Clinic
  • Sofia, Bulgaria, 1606
    • Recruiting
    • University Medical Center "N. I. Pirogov", Clinic of Purulent-Septic Surgery
• China
  • Beijing, China, 100029
    • Recruiting
    • China-Japan Friendship Hospital
  • Bengbu, China, 233099
    • Recruiting
    • The First Affiliated Hospital of Bengbu Medical College
  • Chengdu, China, 610041
    • Recruiting
    • West China Hospital, Sichuan University
  • Guangzhou, China, 510180
    • Recruiting
    • Guangzhou First People's Hospital
  • Guangzhou, China, 510230
    • Recruiting
    • The First Affiliated Hospital of Guangzhou Medical University
  • Hangzhou, China, 310014
    • Recruiting
    • Zhejiang Provincial People's Hospital
  • Hangzhou, China, 310006
    • Recruiting
    • Zhejiang Provincal Hospital of Chinese Medicine
  • Hangzhou, China, 310016
    • Recruiting
    • Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
  • Lishui, China, 323000
    • Recruiting
    • Lishui People's Hospital
  • Liuzhou, China, 530021
    • Recruiting
    • Liuzhou People's Hospital
  • Nanchang, China, 330006
    • Recruiting
    • The 1st Affiliated Hospital of Nanchang University
  • Qingyuan, China, 511518
    • Recruiting
    • Qingyuan People's Hospital
  • Shanghai, China, 200040
    • Recruiting
    • Huashan Hospital
  • Shenzhen, China, 518112
    • Recruiting
    • Shenzhen Third People's Hospital
  • Tianjin, China, 301617
    • Recruiting
    • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
  • Wuhan, China, 430014
    • Recruiting
    • Central Hospital of Wuhan
  • Wuxi, China, 214023
    • Recruiting
    • Wuxi People's Hospital
  • Zhengzhou, China, 471003
    • Recruiting
    • The First Affiliated Hospital of Henan University of Science and Technology
• Colombia
  • Armenia, Colombia, 630004
    • Recruiting
    • Cardiomet CEQUIN Foundation, Department of Nephrology
  • Medellín, Colombia, 050015
    • Recruiting
    • Luz Castro de Gutierrez Medellin General Hospital, Research Center
  • Medellín, Colombia, 050034
    • Recruiting
    • Pablo Tobon Uribe Hospital
  • Medellín, Colombia, 050012
    • Recruiting
    • Hospital Alma Mater de Antioquia
  • Montería, Colombia, 230002
    • Recruiting
    • High Technology Medical Institute S.A.S, IMAT S.A.S.
  • Rionegro, Colombia, 54040
    • Recruiting
    • Somer Clinic
• France
  • Amiens, France, 80054
    • Recruiting
    • Amiens Picardie University Hospital - South, Intensive Care Unit (ICU)
  • Argenteuil, France, 95107
    • Recruiting
    • Victor Dupouy Hospital Center Argenteuil, Intensive Care Unit
  • Marseille, France, 13015
    • Suspended
    • Marseille Nord University Hospitals - AP-HM, Medical Intensive Care Unit, Acute Respiratory Distress and Severe Infections
  • Nantes, France, 44000
    • Recruiting
    • Nantes University Hospital Center - Hotel Dieu Hospital, Department of Infectious and Tropical Diseases
  • Rennes, France, 35000
    • Recruiting
    • Rennes University Hospital Center - Hospital Pontchaillou
  • Tours, France, 37000
    • Recruiting
    • Tours Regional University Hospital Center
• Germany
  • Heidelberg, Germany, 69120
    • Recruiting
    • University Hospital Heidelberg, Clinic for Anesthesiology
  • Baden-Wurttemberg
    • Ulm, Baden-Wurttemberg, Germany, 89081
      • Recruiting
      • University Hospital Ulm, Comprehensive Infectious Diseases Center Ulm (CIDCU)
  • Bavaria
    • Regensburg, Bavaria, Germany, 93053
      • Recruiting
      • University Hospital Regensburg
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60590
      • Recruiting
      • Frankfurt University Clinic
    • Giessen, Hesse, Germany, 35392
      • Recruiting
      • University Hospital Giessen and Marburg GmbH
  • North Rhine-Westphalia
    • Cologne, North Rhine-Westphalia, Germany, 50937
      • Recruiting
      • University Hospital Cologne, Department of Internal Medicine I, Clinical Study Centre II for Infectious Diseases
• Greece
  • Athens, Greece, 11527
    • Recruiting
    • "Sotiria" Chest Diseases Hospital of Athens
  • Athens, Greece, PC 10676
    • Recruiting
    • General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit
  • Athens, Greece, 115 27
    • Recruiting
    • "LAIKO" General Hospital
  • Heraklion, Greece, 715 00
    • Recruiting
    • University General Hospital of Heraklion
  • Piraeus, Greece, 185 36
    • Suspended
    • Tzaneio General Hospital
  • Thessaloniki, Greece, 54642
    • Recruiting
    • General Hospital of Thessaloniki "Ippokratio"
• Israel
  • Haifa, Israel, 3109601
    • Recruiting
    • Rambam Health Care Campus, Institute of Infectious Diseases
  • Holon, Israel, 58100
    • Recruiting
    • Edith Wolfson Medical Center, Department of Infectious Diseases
  • Ramat Gan, Israel, 52621
    • Recruiting
    • Chaim Sheba Medical Center, Department of Infectious Diseases
  • Tel Aviv, Israel, 6423906
    • Recruiting
    • The Tel Aviv Sourasky Medical Center, Infectious Diseases Unit
  • Ẕerifin, Israel, 7033001
    • Recruiting
    • Shamir Medical Center, Department of Infectious Diseases
• Italy
  • Cuneo, Italy, 12100
    • Recruiting
    • Hospital "S. Croce e Carle"
  • Genoa, Italy, 16132
    • Recruiting
    • IRCCS Policlinic Hospital San Martino
  • Milan, Italy, 20162
    • Recruiting
    • Big Metropolitan Hospital Niguarda Regional Health Authority
  • Milan, Italy, 20122
    • Recruiting
    • Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
  • Milan, Italy, 20132
    • Recruiting
    • Hospital San Raffaele, IRCCS
  • Modena, Italy, 41124
    • Recruiting
    • University Polyclinic Hospital of Modena
  • Pavia, Italy, 27100
    • Recruiting
    • Polyclinic San Matteo, IRCCS
  • Pisa, Italy, 56124
    • Recruiting
    • University Hospital of Pisa
  • Siena, Italy, 53100
    • Recruiting
    • AOU Senese
  • Trieste, Italy, 34125
    • Recruiting
    • Giuliano Isontina University Health Authority
• Singapore
  • Singapore, Singapore, 169608
    • Recruiting
    • Singapore General Hospital
  • Singapore, Singapore, 308433
    • Recruiting
    • Tan Tock Seng Hospital
  • Singapore, Singapore, 119074
    • Recruiting
    • National University Hospital
• South Africa
  • Johannesburg, South Africa, 2092
    • Recruiting
    • Helen Joseph Hospital
  • Johannesburg, South Africa, 2193
    • Suspended
    • Milpark Hospital
  • Pretoria, South Africa, 0084
    • Recruiting
    • University of Pretoria / Steve Biko Academic Hospital
  • Pretoria, South Africa, 0084
    • Withdrawn
    • Ryexo Clinical Research
  • Umhlanga, South Africa, 4320
    • Recruiting
    • Practice of R Moodley and MI Sarvan - Umhlanga
• South Korea
  • Daegu, South Korea, 41944
    • Recruiting
    • Kyungpook National University Hospital
  • Seoul, South Korea, 03722
    • Recruiting
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 06351
    • Recruiting
    • Samsung Medical Center
  • Suwon, South Korea, 16499
    • Recruiting
    • Ajou University Hospital
• Spain
  • Barakaldo, Spain, 48903
    • Recruiting
    • University Hospital Cruces
  • Andalusia
    • Seville, Andalusia, Spain, 41009
      • Recruiting
      • University Hospital Virgen Macarena
    • Seville, Andalusia, Spain, 41014
      • Recruiting
      • University Hospital Nuestra Senora de Valme
  • Catalonia
    • Barcelona, Catalonia, Spain, 08003
      • Recruiting
      • Hospital del Mar, Department of Infectious Diseases
    • Barcelona, Catalonia, Spain, 08035
      • Recruiting
      • University Hospital Vall d'Hebron, Intensive Care Unit (ICU)
    • Barcelona, Catalonia, Spain, 08036
      • Suspended
      • Hospital Clinic of Barcelona, Department of Infectious Diseases
  • Madrid
    • Madrid, Madrid, Spain, 28034
      • Recruiting
      • University Hospital Ramon y Cajal, Department of Infectious Diseases
• Taiwan
  • Kaohsiung City, Taiwan, 807377
    • Recruiting
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung City, Taiwan, 833401
    • Recruiting
    • Kaohsiung Chang Gung Memorial Hospital
  • New Taipei City, Taiwan, 220
    • Recruiting
    • Far Eastern Memorial Hospital
  • Taichung, Taiwan, 407219
    • Recruiting
    • Taichung Veterans General Hospital
  • Taichung, Taiwan, 404327
    • Recruiting
    • China Medical University Hospital
  • Taipei, Taiwan, 112201
    • Recruiting
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 11000
    • Recruiting
    • Taipei Medical University Hospital
  • Taoyuan City, Taiwan, 333
    • Recruiting
    • Linkou Chang Gung Memorial Hospital
• Thailand
  • Bangkok, Thailand, 10700
    • Recruiting
    • Siriraj Hospital
  • Bangkok, Thailand, 10300
    • Recruiting
    • Vajira Hospital
  • Chiang Mai, Thailand, 50200
    • Recruiting
    • Maharaj Nakorn Chiang Mai Hospital
  • Hat Yai, Thailand, 90110
    • Recruiting
    • Songklanagarind Hospital
  • Khon Kaen, Thailand, 40002
    • Recruiting
    • Srinagarind Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0006
      • Recruiting
      • University of Alabama at Birmingham School of Medicine, Department of Medicine
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope
    • Los Angeles, California, United States, 90095
      • Recruiting
      • David Geffen School of Medicine at UCLA
    • Sacramento, California, United States, 95817
      • Recruiting
      • UC Davis Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University Hospital - Clifton Road
    • Augusta, Georgia, United States, 30912-5563
      • Recruiting
      • Augusta University Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University Methodist Hospital
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • Recruiting
      • University of Kentucky College of Medicine
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5000
      • Recruiting
      • University of Michigan Health System (UMHS) - A. Alfred Taubman Health Care Center
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Hospital, Department of Medicine, Division of Infectious Diseases
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • DMC Harper University Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine, Infectious Diseases Clinical Research Unit
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medical College - NewYork-Presbyterian Hospital
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Recruiting
      • University of North Carolina at Chapel Hill
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-6243
      • Recruiting
      • University of Pennsylvania School of Medicine
    • Pittsburgh, Pennsylvania, United States, 15213-2582
      • Recruiting
      • UPMC Presbyterian
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
    • Houston, Texas, United States, 77030
      • Recruiting
      • U.T. MD Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Hospital - Texas Medical Center
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • University of Texas Health Science Center at San Antonio
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Recruiting
      • Carilion Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fosmanogepix IV/oral; Fosmanogepix will be administered as an Intravenous (IV) infusion given directly into a vein. There is an option to switch from the IV infusion to the oral form of fosmanogepix which is taken by mouth. Matching placebos for caspofungin and fluconazole will also be administered (a placebo does not have any medicine in it but looks just like the caspofungin and fluconazole).	Drug: Fosmanogepix; IV infusion; Drug: Fosmanogepix; Oral tablet; Drug: Placebo; Matching placebo for caspofungin (IV infusion); Drug: Placebo; Matching placebo for fluconazole (oral capsule); Drug: Placebo; Matching placebo for fosmanogepix (IV infusion); Drug: Placebo; Matching placebo for fosmanogepix (oral tablet)
Active Comparator: Caspofungin IV/ Fluconazole oral; Caspofungin will be administered as an intravenous (IV) infusion given directly into a vein. There is an option to switch from the IV infusion to oral fluconazole which is taken by mouth. Matching placebos for fosmanogepix will also be administered (a placebo does not have any medicine in it but looks just like the medicine fosmanogepix being studied).	Drug: Fluconazole; Fluconazole oral capsule; Drug: Placebo; Matching placebo for caspofungin (IV infusion); Drug: Placebo; Matching placebo for fluconazole (oral capsule); Drug: Placebo; Matching placebo for fosmanogepix (IV infusion); Drug: Placebo; Matching placebo for fosmanogepix (oral tablet); Drug: Caspofungin; IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients alive at Day 30	Day 30
Proportion of patients with an overall response of treatment success at end of study treatment (EOST)	EOST (up to Day 42)

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma concentrations versus time of fosmanogepix (prodrug) and manogepix (active moiety)	Day 3: 0, 3, 6, 9 and 24 hours post-dose; Day 7, 14, 21, 28, 35; EOST: 72 and 192 hours post-dose
Proportion of patients with an overall response of treatment success at Day 14	Day 14
Proportion of patients with an overall response of treatment success at end of IV treatment (EOIV)	up to Day 42
Proportion of patients with an overall response of treatment success (sustained) at follow-up 6 weeks after EOST	approximately up to 12,5 weeks
Time to first negative blood culture in patients on fosmanogepix compared to caspofungin/fluconazole	Baseline up to follow-up 6-weeks after EOST (approximately up to 12,5 weeks)
Incidence of treatment-emergent adverse event (TEAEs), serious adverse events (SAEs), treatment-related adverse events (AEs), adverse events of special interest (AESI)and AEs leading to discontinuation	Screening up to follow-up 6-weeks after EOST (approximately up to 12,5 weeks)
Number of patients with clinically significant laboratory abnormalities	Baseline up to follow-up 6-weeks after EOST (approximately up to 12,5 weeks)
Number of patients with abnormal neurological examination findings	Baseline up to follow-up 6-weeks after EOST (approximately up to 12,5 weeks)
Assessment of 12-lead electrocardiogram (ECGs)	Baseline up to follow-up 6-weeks after EOST (approximately up to 12,5 weeks)
Proportion of patients with an overall response of treatment success at Day 7	Day 7
Proportion of patients with clinical response of success at Day 7, 14, EOIV, EOST, Follow-up 6- weeks after EOST	Day 14, EOIV (up to Day 42), EOST (up to Day 42), Follow-up 6-weeks after EOST]
Proportion of patients with mycological response of eradication or presumed eradication at Day 7, 14, EOIV, EOST, Follow-up 6-weeks after EOST	Day 14, EOIV (up to Day 42), EOST (up to Day 42), Follow-up 6-weeks after EOST

Collaborators and Investigators

• Sponsor: Basilea Pharmaceutica
• Collaborators: Biomedical Advanced Research and Development Authority
• Investigators: Study Director: Manuel Häckl, MD, Basilea Pharmaceutica International Ltd, Allschwil

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2024
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): January 30, 2028

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 16, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Candida; Fungal infection; Anti-fungal; Yeast
• Additional Relevant MeSH Terms: Invasive Fungal Infections; Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections and Mycoses; Candidiasis; Fungemia; Pathological Conditions, Signs and Symptoms; Mycoses; Candidemia; Candidiasis, Invasive; Torulopsis; Peptides; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Lipids; Azoles; Peptides, Cyclic; Lipopeptides; Triazoles; Echinocandins; Caspofungin; Fluconazole
• Other Study ID Numbers: FMGX-CS-301; 2022-500455-23-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No