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

Purpose

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.

Condition

  • Invasive Mold Infections

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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. Coronavirus disease 2019 (COVID-19) associated mucormycosis.

4. Invasive fungal disease caused by more than one fungal pathogen is not permitted in
Cohort A but is 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
An open-label, 2-cohort study
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort A: Experimental Treatment 		Patients will receive the study drug. Fosmanogepix will be administered as an Intravenous (IV) infusion or in oral form.
  • Drug: Fosmanogepix IV infusion
    Fosmanogepix will be administered IV
  • Drug: Fosmanogepix oral tablet
    Fosmanogepix will be administered orally.
Active Comparator
Cohort A: Comparator Antifungal Treatment 		Best available therapy (BAT) administered as IV or orally per standard guidelines.
  • Drug: Standard of care antifungal therapy
    Standard of care antifungal therapy will be administered in accordance with their respective product labels and/or standard practice guidelines
Experimental
Cohort B 		Patients will receive the study drug. Fosmanogepix will be administered as an Intravenous (IV) infusion or in oral form.
  • Drug: Fosmanogepix IV infusion
    Fosmanogepix will be administered IV
  • Drug: Fosmanogepix oral tablet
    Fosmanogepix will be administered orally.

Recruiting Locations

University of Alabama at Birmingham School of Medicine, Department of Medicine
Birmingham, Alabama 35294-0006

City of Hope
Duarte, California 91010

David Geffen School of Medicine at UCLA
Los Angeles, California 90095-1690

UC Davis Medical Center
Sacramento, California 95817

University of Kentucky Medical Center, Division of Infectious Diseases
Lexington, Kentucky 40506

Johns Hopkins Hospital
Baltimore, Maryland 21231

University of Michigan Health System (UMHS) - A. Alfred Taubman Health Care Center
Ann Arbor, Michigan 48109-5000

Karmanos Cancer Institute - Detroit
Detroit, Michigan 48201

University of Minnesota, M Health Fairview Medical Center
Minneapolis, Minnesota 55455

Washington University School of Medicine, Infectious Diseases Clinical Research Unit
St Louis, Missouri 63110

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27514

Duke University Medical Center, Duke Infectious Diseases
Durham, North Carolina 27710

The University of Texas Health Science Center at Houston, Department of Internal Medicine
Houston, Texas 77030

UT MD Anderson Cancer Center
Houston, Texas 77030

More Details

Status
Recruiting
Sponsor
Basilea Pharmaceutica

Study Contact

Alison Kuchta, MD
+41616061243
kuchtaa@basileapharma.com