NCT06925321

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 234 (estimated)
• Sponsor: Basilea Pharmaceutica · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Invasive Mold Infections

Interventions

Type	Name	Description
DRUG	Fosmanogepix IV infusion	Fosmanogepix will be administered IV
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
DRUG	Fosmanogepix oral tablet	Fosmanogepix will be administered orally.

Timeline

• Start date: 2025-08-26
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2025-04-13
• Last updated: 2026-04-08

Locations

41 sites across 12 countries: United States, Australia, Austria, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, Thailand

Regulatory

• FDA-regulated drug study