A Phase 3 Efficacy and Safety Study of Fosmanogepix for t... | NCT06925321

Studies
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.

NCT06925321

Sponsor

Basilea Pharmaceutica

Status

Recruiting

Last Update Posted

Jun 15, 2026Actual

Enrollment

234Estimated

Phase

Phase 3

Conditions

Invasive Mold Infections

Interventions

Fosmanogepix IV infusion
Standard of care antifungal therapy
Fosmanogepix oral tablet

Countries

United States
Australia
Austria
Belgium
Brazil
Canada
France
Germany
Greece
Israel
Italy
Netherlands
Spain
Taiwan
Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2024-516216-16-00	EU Trial (CTIS) Number

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

YesNCT06433128Available

Start Date

Aug 26, 2025Actual

Primary Completion Date

Feb 2028Estimated

Completion Date

Feb 2028Estimated

First Submitted Date

Mar 27, 2025

First Submission Date that Met QC Criteria

Apr 11, 2025

First Posted Date

Apr 13, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2026

Last Update Posted Date

Jun 15, 2026Actual

Name	Class
Biomedical Advanced Research and Development Authority	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

234Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort A: Experimental Treatment	Experimental	Patients will receive the study drug. Fosmanogepix will be administered as an Intravenous (IV) infusion or in oral form.	Drug: Fosmanogepix IV infusion Drug: Fosmanogepix oral tablet
Cohort A: Comparator Antifungal Treatment	Active Comparator	Best available therapy (BAT) administered as IV or orally per standard guidelines.	Drug: Standard of care antifungal therapy
Cohort B	Experimental	Patients will receive the study drug. Fosmanogepix will be administered as an Intravenous (IV) infusion or in oral form.	Drug: Fosmanogepix IV infusion Drug: Fosmanogepix oral tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fosmanogepix IV infusion	Drug	Fosmanogepix will be administered IV	Cohort A: Experimental Treatment Cohort B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Day 42 all-cause mortality rate		Day 42

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Main Inclusion Criteria:

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.

Main Exclusion Critera:

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.
Moderate or severe hepatic impairment.
Patient who is pregnant or lactating.
Known hypersensitivity to fosmanogepix, manogepix, or any of their excipients.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alison Kuchta, MD	Contact	+41616061243		kuchtaa@basileapharma.com
Marc Engelhardt, MD	Contact	+41797010551		marc.engelhardt@basilea.com

Overall Officials

Name	Affiliation	Role
Alison Kuchta, MD	Basilea Pharmaceutica International Ltd, Allschwil	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham School of Medicine, Department of Medicine	Recruiting	Birmingham	Alabama	35294-0006	United States

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections