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Study of fosmanogepix compared to standard antifungal drugs for treating invasive mold infections in adults

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on treating invasive mold infections caused by various types of fungi, including Aspergillus, Fusarium, Lomentospora prolificans, and Mucorales fungi. The main treatment being tested is fosmanogepix, which will be given both as an infusion into a vein and as tablets by mouth. The study will compare fosmanogepix with other antifungal medications including voriconazole, anidulafungin, amphotericin B, rezafungin, micafungin, caspofungin, isavuconazole, posaconazole, and terbinafine.

The purpose of this research is to evaluate how well fosmanogepix works and how safe it is for treating adults who have serious fungal infections. The study will look at whether the treatment helps patients survive and recover from their infections. The treatment period can last up to 180 days, depending on how each patient responds.

During the study, doctors will monitor patients' progress through various tests and examinations. They will check how well the infection responds to treatment by looking at clinical symptoms, laboratory tests, and imaging scans. They will also carefully track any side effects that may occur during treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive fosmanogepix through an intravenous (IV) infusion, which means the medication will be given directly into your vein

    The IV infusion will last 3 hours

    Blood samples will be collected before the infusion and at 3, 6, and 9 hours after the start of the infusion on day 3

    A final blood sample will be taken at 24 hours, before the day 4 dose

  2. Step 2

    Transition to oral medication

    Starting from day 7, you will begin taking fosmanogepix tablets by mouth

    Blood samples will be collected on days 7, 14, 28, and 42 to measure medication levels

  3. Step 3

    Monitoring and evaluation period

    Your response to treatment will be evaluated on day 42 and day 84

    Doctors will assess your clinical condition, perform laboratory tests, and take images to check your progress

    Regular examinations will include heart monitoring (ECG) and neurological checks

    Any side effects will be recorded throughout the treatment period

  4. Step 4

    Final assessment

    After completing treatment, you will have a follow-up period lasting 6 weeks

    Final blood samples will be collected 72 hours (±1 day) and 192 hours (±2 days) after your last dose

    The total duration of your participation may be up to 8 months

Who can join the trial?

10 criteria

  • Must be an adult (18 years or older)
  • Must have a confirmed diagnosis of invasive mold infection (a serious fungal infection that has spread inside the body) caused by specific types of fungi:
    • Aspergillus species (in patients with limited treatment options)
    • Fusarium species
    • Lomentospora prolificans
    • Mucorales fungi
    • Other molds that are resistant to multiple medications
    • The infection must be either:
      • Proven (confirmed through laboratory tests)
      • Probable (highly likely based on medical evidence)
      • Must be in a condition that allows doctors to properly treat the source of the infection
      • Both men and women may participate in the study

Who cannot join the trial?

15 criteria

  • Age below 18 years
  • Pregnancy or breastfeeding
  • Known severe allergic reactions to medications similar to the study drug
  • Severe liver problems (as determined by blood tests)
  • Severe kidney problems requiring dialysis (a procedure to filter blood when kidneys don't work properly)
  • Active cancer treatment that might interfere with the study medication
  • Taking other medications that could interact with the study drug
  • Unable to take oral medications
  • Participation in another clinical trial within the past 30 days
  • Having any condition that, in the opinion of the study doctor, would make participation unsafe
  • History of aspergillosis (fungal infection) that is resistant to all available treatments
  • Severe heart conditions or unstable heart disease
  • History of organ transplantation
  • Active or chronic hepatitis B or C infection
  • Known HIV infection with inadequate immune system function
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Investigated drugs

Fosmanogepix is an antifungal medication being studied for treating serious fungal infections. It works against various types of mold infections that can be difficult to treat with other medications. This new drug is specifically designed to fight against invasive infections caused by different types of molds, including Aspergillus, Fusarium, and other resistant fungi. It may provide a treatment option for patients who have limited choices due to drug resistance or who haven't responded well to other antifungal treatments.

What is already known about the treatment

Fosmanogepix - A novel antifungal medication administered intravenously for the treatment of severe invasive mold infections, particularly in cases involving Aspergillus, Fusarium, Lomentospora prolificans, and Mucorales fungi. Currently undergoing Phase 3 clinical trials, this medication represents a promising treatment option for patients with limited therapeutic alternatives, especially those facing multidrug-resistant mold infections. Fosmanogepix works by targeting the fungal cell wall through a unique mechanism of action, offering a potential solution for infections that have become resistant to conventional antifungal treatments. The drug belongs to the class of novel antifungal agents and is being evaluated as a potential breakthrough therapy for patients with difficult-to-treat invasive fungal infections.

Investigated diseases

  • Invasive Mold Infection (IMI)

    A serious fungal infection that occurs when certain types of molds invade deep tissues or organs in the body. The infection typically begins when a person inhales microscopic mold spores, which then spread beyond the respiratory system. Common causative molds include Aspergillus species, Fusarium species, Lomentospora prolificans, and Mucorales fungi. The infection can affect multiple organs and typically develops more frequently in people with weakened immune systems. The condition progresses by spreading through blood vessels and tissues, causing damage to affected organs.

  • Aspergillosis

    A fungal infection caused by Aspergillus mold species that commonly starts in the respiratory system. The fungus can grow and spread within the lungs, forming masses of fungal fibers and inflammatory cells. In some cases, the infection can spread beyond the lungs to other parts of the body. The condition typically develops gradually, with symptoms becoming more noticeable as the infection progresses.

  • Fusariosis

    An infection caused by Fusarium fungi that can affect various parts of the body. The infection commonly enters through damaged skin or through inhalation. Fusarium can spread throughout the body through the bloodstream. The infection may start on the skin or in the respiratory system before potentially spreading to other organs.

  • Mucormycosis

    An infection caused by fungi of the Mucorales order that typically begins in the sinuses or lungs. The fungi can spread rapidly through blood vessels, causing tissue death in infected areas. The infection can progress to nearby structures including the eyes and brain. The condition develops relatively quickly compared to other fungal infections.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516216-16-00Protocol codeFMGX-CS-302Estimated enrolment234 patientsSponsorBasilea Pharmaceutica International AG Allschwil

sourced from the EU Clinical Trials Register and site verification

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