Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2025
Fosmanogepix for the Treatment of Invasive Mold Diseases Caused by Aspergillus Species and Rare Molds: A Phase 2, Open-Label Study (AEGIS).
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04240886 (A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of APX001 in the Treatment of Patients With Invasive Mold Infections Caused by Aspergillus Species or Rare Molds), which is not on this map. Cited by 23 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of APX001 in the Treatment of Patients With Invasive Mold Infections Caused by Aspergillus Species or Rare Molds
Who cites it
23 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Guideline
- Brazilian task force for the management of mucormycosis.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious DiseasesGuideline
- Invasive aspergillosis in autoimmune inflammatory rheumatic diseases: epidemiology, risk factors, diagnosis, management and challenges.Annals of medicine · 2026Review
- Fosmanogepix: A comprehensive review of its origin, mechanism, antifungal efficacy, and resistance (Review).Biomedical reports · 2026Review
- Fosmanogepix Treatment for Coccidioidomycosis Under an Expanded Access Program.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Article
- Multidrug Resistance and Host Adaptation in Candida Auris: From Molecular Mechanisms to Emerging Therapeutic Frontiers.Mycopathologia · 2026Review
- Fusarium solani Skin and Soft Tissue Infection in a Patient With Chronic Sclerosing Skin Graft-vs-Host Disease: A Case Report.The American journal of case reports · 2026Article
- Manogepix demonstrates potentAntimicrobial agents and chemotherapy · 2026Article
- New Perspectives on Antimicrobial Agents: Fosmanogepix.Antimicrobial agents and chemotherapy · 2026Review
- Multicenter surveillance of antifungal susceptibility of clinicalMicrobiology spectrum · 2026Article
- Nosocomial invasive Aspergillus calidoustus infection in a CAR-T cell-treated patient with concomitant Aspergillus fumigatus respiratory infection.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2026Article
- Invasive aspergillosis in lung and heart transplant recipients.JHLT open · 2026Article
- RefractoryASM case reports · 2026Article
- Aspergillosis: An Update on Epidemiology, Risk Factors, Diagnosis, Susceptibility, and Treatment.Journal of fungi (Basel, Switzerland) · 2026Review
- The Silent Pandemic: Antifungal Resistance and the Future of Invasive Fungal Disease Management.Microorganisms · 2026Review
- MultisystemASM case reports · 2026Article
- Frequency, Timing, and Patient Factors Associated with Recurrence of Disseminated Cutaneous Coccidioidomycosis.Journal of fungi (Basel, Switzerland) · 2026Article
- Assessment of the molecular identification algorithm and its impact on antifungal susceptibilities against clinicalJAC-antimicrobial resistance · 2026Article
- Fungi between threat and promise: global perspectives on health and innovation.Frontiers in microbiology · 2026Review
- Cerebral Aspergillosis: Diagnostic Challenges, Therapeutic Strategies, and Future Research.CNS drugs · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
backgroundFosmanogepix (FMGX) inhibits glycosylphosphatidylinositol anchored cell wall transfer protein 1, essential for anchoring mannoproteins to fungal cell wall, critical for host invasion. This Phase 2 study evaluated efficacy and safety of FMGX treatment in invasive mold diseases (IMDs) by Aspergillus spp. and rare molds in adults with limited treatment options.
methodsParticipants (≥18 years) received FMGX 1000 mg intravenously (IV; 3-hour infusion) twice on Day 1 followed by 600 mg IV or 800 mg oral (optional from Day 4) once a day for ≤42 days. Key endpoints were all-cause mortality (Day 42) and Data Review Committee (DRC)-assessed global response (end of study treatment), adjudicated as success (complete or partial response) or failure (stable disease or progression of disease or death).
resultsOf 21 participants enrolled (safety population), 20 were included in the modified Intent-to-Treat population (mean age: 61.9 years; females: 2 [10%]). Day-42 all-cause mortality was 25% (80% confidence interval [CI]: 12.7%-41.5%). DRC-assessed global response success rate was 40% (80% CI: 24.9%-56.7%). 258 adverse events (AEs) were reported (n = 21). 15 participants experienced 36 FMGX-related AEs, 2 had 3 serious AEs. Three participants (14.3%) discontinued study treatment due to FMGX-related AEs. Nine deaths (43%) were reported. One death was assessed as possibly related and unrelated to FMGX by the investigator and Data and Safety Monitoring Board, respectively.
conclusionsSafety profile was acceptable in high-risk patients with limited treatment options, supporting development of FMGX for treating IMDs caused by Aspergillus and rare molds. Clinical Trials Registration. NCT04240886; EudraCT number: 2019-001386-33.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.