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

Conditions

• Invasive Mold Infections

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Aug 26, 2025

Status verified

May 2026

Primary completion

Feb 29, 2028

Completion

Feb 29, 2028

Study Design

Enrollment

234 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A: Experimental Treatment
  Patients will receive the study drug. Fosmanogepix will be administered as an Intravenous (IV) infusion or in oral form.
• Active Comparator: Cohort A: Comparator Antifungal Treatment
  Best available therapy (BAT) administered as IV or orally per standard guidelines.
• Experimental: Cohort B
  Patients will receive the study drug. Fosmanogepix will be administered as an Intravenous (IV) infusion or in oral form.

Primary Outcome Measure

Day 42 all-cause mortality rate [ Time Frame: Day 42 ]

Central Contacts

• Alison Kuchta, MD
  +41616061243
  [email protected]
• Marc Engelhardt, MD
  +41797010551
  [email protected]

Locations (15)

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