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

Summary

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.

Conditions

• Candidemia
• Candidiasis, Invasive

Interventions

DRUG

Fosmanogepix

IV infusion

DRUG

Fosmanogepix

Oral tablet

DRUG

Caspofungin

IV infusion

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)

Sponsors & Collaborators

• Biomedical Advanced Research and Development Authority

  collaborator FED

• Basilea Pharmaceutica

  lead INDUSTRY

Principal Investigators

• Manuel Häckl, MD · Basilea Pharmaceutica International Ltd, Allschwil

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-11

Primary Completion

2028-01-30

Completion

2028-01-30

FDA Drug

Yes

Countries

• United States
• Argentina
• Australia
• Austria
• Belgium
• Brazil
• Bulgaria
• China
• Colombia
• France
• Germany
• Greece
• Israel
• Italy
• Singapore
• South Africa
• South Korea
• Spain
• Taiwan
• Thailand

Study Locations