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NCT Number: NCT06925321

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

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.

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Key information

Conditions

Invasive Mold Infections Bacterial Infections and Mycoses Infections Mycoses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Monash Medical Center Clayton, Clayton, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fosmanogepix IV infusion

Drug

Fosmanogepix will be administered IV

Standard of care antifungal therapy

Drug

Standard of care antifungal therapy will be administered in accordance with their respective product labels and/or standard practice guidelines

Fosmanogepix oral tablet

Drug

Fosmanogepix will be administered orally.

Primary outcomes

  1. Day 42 all-cause mortality rate

    Time frame: Day 42

Secondary outcomes

  1. Proportion of patients with overall response of treatment success

    Time frame: Day 42, Day 84 and up to 180 days

  2. Proportion of patients with clinical response of treatment success

    Time frame: Day 42, Day 84 and up to 180 days

  3. Proportion of patients with mycological response of eradication or presumed eradication

    Time frame: Day 42, Day 84 and up to 180 days

  4. Proportion of patients with radiological response of complete response or partial response

    Time frame: Day 42, Day 84 and up to 180 days

  5. All-cause mortality rate at Day 84

    Time frame: Day 84

  6. Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), treatment-related AEs, adverse events of special interest (AESI), and AEs leading to discontinuation

    Time frame: Screening up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)

  7. Number of patients with clinically significant laboratory abnormalities

    Time frame: Up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)

  8. Number of patients with abnormal neurological examination findings

    Time frame: Up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)

  9. Assessment of 12-lead electrocardiogram corrected QT (Fridericia method) Interval (ECG QTcF Interval)

    Time frame: Up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)

  10. Plasma concentrations versus time of fosmanogepix (prodrug) and manogepix (active moiety) following IV administration

    Time frame: Pre-dose, 3,6, and 9 hours post-start of the 3-hour IV infusion on Day 3, and at 24 hours (prior to Day 4 dosing)

  11. Plasma concentrations versus time of fosmanogepix (prodrug) and manogepix (active moiety) following oral administration

    Time frame: On days 7, 14, 28, and 42. Post-dose plasma samples will also be collected: 72 hrs and 192 hrs after last dose.

Study contacts

Contact information is provided by the study sponsor or research team.

Alison Kuchta, MD

CONTACT

[email protected]

+41616061243

Marc Engelhardt, MD

CONTACT

[email protected]

+41797010551

Sponsors and collaborators

Lead sponsor

Basilea Pharmaceutica

Industry

Collaborators

  • Biomedical Advanced Research and Development Authority

Registry information

Official study title

An Interventional Phase 3, Open-label, Two-cohort Study to Investigate the Efficacy and Safety of Fosmanogepix in Adult Patients With Invasive Mold Infections Caused by Aspergillus Spp., Fusarium Spp., Lomentospora Prolificans, Mucorales Fungi, or Other Multidrug Resistant Molds

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 13, 2025
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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