A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.
An Interventional Phase 3, Open-label, Two-cohort Study to Investigate the Efficacy and Safety of Fosmanogepix in Adult Patients With Invasive Mold Infections Caused by Aspergillus Spp., Fusarium Spp., Lomentospora Prolificans, Mucorales Fungi, or Other Multidrug Resistant Molds
1 other identifier
interventional
234
11 countries
44
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of fosmanogepix (administered IV or oral) for the treatment of adult patients with invasive mold infections. The study is looking for patients who have been diagnosed with invasive mold infections. The maximum study duration will be approximately 8 months, including a target study treatment duration of 84 days which can be extended up to 180 days and follow-up period. The patient will be assigned to one of two treatment cohorts: Cohort A (primary therapy): Patients will receive either the study drug or institutional standard of care antifungal treatment. Cohort B (salvage treatment; i.e. treatment given after patients did not respond to previous treatments or did not tolerate them): Patients will receive the study drug The primary aim is to compare the all cause mortality with a fixed threshold at Day 42.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2025
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2025
CompletedFirst Posted
Study publicly available on registry
April 13, 2025
CompletedStudy Start
First participant enrolled
August 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
April 22, 2026
April 1, 2026
2.4 years
March 27, 2025
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Day 42 all-cause mortality rate
Day 42
Secondary Outcomes (11)
Proportion of patients with overall response of treatment success
Day 42, Day 84 and up to 180 days
Proportion of patients with clinical response of treatment success
Day 42, Day 84 and up to 180 days
Proportion of patients with mycological response of eradication or presumed eradication
Day 42, Day 84 and up to 180 days
Proportion of patients with radiological response of complete response or partial response
Day 42, Day 84 and up to 180 days
All-cause mortality rate at Day 84
Day 84
- +6 more secondary outcomes
Study Arms (3)
Cohort A: Experimental Treatment
EXPERIMENTALPatients will receive the study drug. Fosmanogepix will be administered as an Intravenous (IV) infusion or in oral form.
Cohort A: Comparator Antifungal Treatment
ACTIVE COMPARATORBest available therapy (BAT) administered as IV or orally per standard guidelines.
Cohort B
EXPERIMENTALPatients will receive the study drug. Fosmanogepix will be administered as an Intravenous (IV) infusion or in oral form.
Interventions
Fosmanogepix will be administered IV
Standard of care antifungal therapy will be administered in accordance with their respective product labels and/or standard practice guidelines
Fosmanogepix will be administered orally.
Eligibility Criteria
You may qualify if:
- Diagnosis of proven or probable Invasive mold infection (IMI) defined in accordance with the Revision and Update of the Consensus Definitions of Invasive Fungal Disease from the EORTC/MSGERC as adapted for this study and caused by Aspergillus spp. (in patients with limited treatment options), Fusarium spp., Lomentospora prolificans, Mucorales fungi, or other multi-drug resistant molds.
- Patient's condition allows for appropriate infection source control measures.
- Refractory hematologic malignancy.
- Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
- Coronavirus disease 2019 (COVID-19) associated mucormycosis.
- Invasive fungal disease caused by more than one fungal pathogen is not permitted in Cohort A but is permitted in Cohort B.
- Patients with a Karnofsky Performance Status \< 20 at Screening.
- Requirement, or anticipated requirement, for hemodialysis, peritoneal dialysis, or hemofiltration.
- Patients with known human immunodeficiency virus infection.
- Ongoing neurological disorders.
- Patients receiving hospice/comfort care only.
- Other medical or psychiatric condition.
- Current use of any prohibited concomitant medication(s).
- Current/ previous administration of an investigational drug within 30 days.
- Prior enrollment in this or any previous study of fosmanogepix.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
University of Alabama at Birmingham School of Medicine, Department of Medicine
Birmingham, Alabama, 35294-0006, United States
City of Hope
Duarte, California, 91010, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095-1690, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
University of Kentucky Medical Center, Division of Infectious Diseases
Lexington, Kentucky, 40506, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21231, United States
University of Michigan Health System (UMHS) - A. Alfred Taubman Health Care Center
Ann Arbor, Michigan, 48109-5000, United States
Karmanos Cancer Institute - Detroit
Detroit, Michigan, 48201, United States
University of Minnesota, M Health Fairview Medical Center
Minneapolis, Minnesota, 55455, United States
Washington University School of Medicine, Infectious Diseases Clinical Research Unit
St Louis, Missouri, 63110, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Duke University Medical Center, Duke Infectious Diseases
Durham, North Carolina, 27710, United States
The University of Texas Health Science Center at Houston, Department of Internal Medicine
Houston, Texas, 77030, United States
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Monash Medical Center Clayton
Clayton, 3168, Australia
The Alfred Hospital
Melbourne, 3004, Australia
Peter MacCallum Cancer Center
Melbourne, 3050, Australia
Royal Melbourne Hospital
Parkville, 3050, Australia
Princess Alexandra Hospital
Woolloongabba, 4102, Australia
Kepler University Hospital GmbH, Department of Internal Medicine IV - Pulmonology
Linz, 4021, Austria
Medical University Vienna, Department of Internal Medicine I, Clinical Department of Infections and Tropical Medicine
Vienna, 1090, Austria
Charleroi Grand Hospital (GHDC) - Les Viviers Site
Charleroi, 6000, Belgium
University Hospitals Leuven, Campus Gasthuisberg, Department of Hematology
Leuven, 3000, Belgium
UCL Mont-Godinne University Hospitals
Yvoir, 5530, Belgium
University of Alberta
Edmonton, Alberta, T6G 2R3, Canada
Juravinski Hospital - Hamilton Health Sciences
Hamilton, Ontario, L8V 1C3, Canada
Vancouver Coastal Health Research Institute (VCHRI)
Vancouver, V5Z 1M9, Canada
Nantes University Hospital Center - Hotel Dieu Hospital, Department of Infectious and Tropical Diseases
Nantes, 44000, France
University Medical Center of Johannes Gutenberg University Mainz
Mainz, Rhineland-Palatinate, 55131, Germany
Rambam Health Care Campus, Institute of Infectious Diseases
Haifa, 3109601, Israel
Chaim Sheba Medical Center, Department of Infectious Diseases
Ramat Gan, 52621, Israel
The Tel Aviv Sourasky Medical Center, Infectious Diseases Unit
Tel Aviv, 6423906, Israel
Shamir Medical Center, Department of Infectious Diseases
Ẕerifin, 7033001, Israel
Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
Milan, 20122, Italy
University Polyclinic Hospital of Modena
Modena, 41124, Italy
Polyclinic San Matteo, IRCCS
Pavia, 27100, Italy
University Hospital of Pisa
Pisa, 56126, Italy
Giuliano Isontina University Health Authority
Trieste, 34125, Italy
Radboud University Medical Center (Radboudumc), Department of Intensive Care
Nijmegen, 6525GA, Netherlands
Erasmus Medical Center, Deoartment of Infectious Diseases
Rotterdam, 3015 GD, Netherlands
University Hospital Virgen Macarena
Seville, Andalusia, 41009, Spain
Hospital del Mar, Department of Infectious Diseases
Barcelona, Catalonia, 08003, Spain
University Hospital Cruces
Barakaldo, 48903, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
University Hospital Ramon y Cajal, Department of Infectious Diseases
Madrid, 28034, Spain
Faculty of Medicine, Siriraj Hospital
Bangkok, 10700, Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200, Thailand
Songklanagarind Hospital
Hat Yai, 90110, Thailand
Srinagarind Hospital
Khon Kaen, 40002, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alison Kuchta, MD
Basilea Pharmaceutica International Ltd, Allschwil
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
March 27, 2025
First Posted
April 13, 2025
Study Start
August 26, 2025
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
February 1, 2028
Last Updated
April 22, 2026
Record last verified: 2026-04