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

Basilea Pharmaceutica

Status and phase: Begins enrollment this month; Phase 3

Conditions: Invasive Mold Infections

Treatments: Drug: Fosmanogepix oral tablet; Drug: Standard of care antifungal therapy; Drug: Fosmanogepix IV infusion

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT06925321

FMGX-CS-302

Details and patient eligibility

About

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.

Enrollment: 219 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

1. 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.
2. Patient's condition allows for appropriate infection source control measures.

Main Exclusion Critera:

1. Refractory hematologic malignancy.
2. Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
3. COVID-19 associated mucormycosis.
4. Invasive fungal disease caused by more than one fungal pathogen are not permitted in Cohort A but are permitted in Cohort B.
5. Patients with a Karnofsky Performance Status < 20 at Screening.
6. Requirement, or anticipated requirement, for hemodialysis, peritoneal dialysis, or hemofiltration.
7. Patients with known human immunodeficiency virus infection.
8. Ongoing neurological disorders.
9. Patients receiving hospice/comfort care only.
10. Other medical or psychiatric condition.
11. Current use of any prohibited concomitant medication(s).
12. Current/ previous administration of an investigational drug within 30 days.
13. Prior enrollment in this or any previous study of fosmanogepix.
14. Moderate or severe hepatic impairment.
15. Patient who is pregnant or lactating.
16. Known hypersensitivity to fosmanogepix, manogepix, or any of their excipients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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219 participants in 3 patient groups

Cohort A: Experimental Treatment

Experimental group

Description:

Patients will receive the study drug. Fosmanogepix will be administered as an Intravenous (IV) infusion or in oral form.

Treatment:

Drug: Fosmanogepix IV infusion

Drug: Fosmanogepix oral tablet

Cohort A: Comparator Antifungal Treatment

Active Comparator group

Description:

Best available therapy (BAT) administered as IV or orally per standard guidelines.

Treatment:

Drug: Standard of care antifungal therapy

Cohort B

Experimental group

Description:

Patients will receive the study drug. Fosmanogepix will be administered as an Intravenous (IV) infusion or in oral form.

Treatment:

Drug: Fosmanogepix IV infusion

Drug: Fosmanogepix oral tablet