Open-label Study of APX001 for Treatment of Patients With Invasive Mold Infections Caused by Aspergillus or Rare Molds

Phase 2 Terminated 21 enrolled Basilea Pharmaceutica

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase 2, multicenter study to evaluate APX001 for the treatment of invasive fungal infections caused by Aspergillus spp. or rare molds (eg, Scedosporium spp., Fusarium spp., and Mucorales fungi).

Timeline

Start: 2020-01-04
Primary completion: 2022-03-29
Completion: 2022-05-09

Outcome

Outcome not reported

Stopped (Business): “The Sponsor made a strategic decision to terminate the study, in order to prioritize a randomized comparative Phase 3 trial in the same indication. This decision was not based on any safety concerns”

Publications

Results Hodges MR, Tawadrous M, Cornely OA, Thompson GR, Slavin MA, Maertens JA, Dadwal SS, Rahav G, Hazel S, Almas M, Jakate A, Pypstra R. Fosmanogepix for the Treatment of Invasive Mold Diseases Caused by Aspergillus Species and Rare Molds: A Phase 2, Open-Label Study (AEGIS). Clin Infect Dis. 2025 Dec 24;81(5):e302-e309. doi: 10.1093/cid/ciaf185.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fosmanogepix	Small molecule	600 mg	Intravenous
Subject	Fosmanogepix	Small molecule	800 mg	Intravenous