2026-04-17T01:14:11Zhttps://recercat.cat/oai/requestoai:recercat.cat:11351/104312025-10-24T08:47:37Zcom_2072_378070com_2072_378040com_2072_378071col_2072_378092col_2072_378097
RECERCAT
author
Pappas, Peter G.
author
Vazquez, Jose A.
author
Oren, Ilana
author
Rahav, Galia
author
aoun, mickael
author
Bulpa, Pierre
author
Ferrer, Ricard
2025-10-24T08:47:37Z
2025-10-24T08:47:37Z
2023-10-11T12:21:59Z2023-10-11T12:21:59Z2023-10
http://hdl.handle.net/11351/10431
Safety; Antifungal; CandidaemiaSeguridad; Antifúngico; CandidemiaSeguretat; Antifúngic; CandidèmiaBackground
Fosmanogepix is a first-in-class antifungal targeting the fungal enzyme Gwt1, with broad-spectrum activity against yeasts and moulds, including multidrug-resistant fungi, formulated for intravenous (IV) and oral administration.
Methods
This global, multicenter, non-comparative study evaluated the safety and efficacy of fosmanogepix for first-line treatment of candidaemia in non-neutropenic adults. Participants with candidaemia, defined as a positive blood culture for Candida spp. within 96 h prior to study entry, with ≤2 days of prior systemic antifungals, were eligible. Participants received fosmanogepix for 14 days: 1000 mg IV twice daily on Day 1, followed by maintenance 600 mg IV once daily, and optional switch to 700 mg orally once daily from Day 4. Eligible participants who received at least one dose of fosmanogepix and had confirmed diagnosis of candidaemia (<96 h of treatment start) composed the modified intent-to-treat (mITT) population. Primary efficacy endpoint was treatment success at the end of study treatment (EOST) as determined by the Data Review Committee. Success was defined as clearance of Candida from blood cultures with no additional antifungal treatment and survival at the EOST.
Results
Treatment success was 80% (16/20, mITT; EOST) and Day 30 survival was 85% (17/20; 3 deaths unrelated to fosmanogepix). Ten of 21 (48%) were switched to oral fosmanogepix. Fosmanogepix was well tolerated with no treatment-related serious adverse events/discontinuations. Fosmanogepix had potent in vitro activity against baseline isolates of Candida spp. (MICrange: CLSI, 0.002–0.03 mg/L).
Conclusions
Results from this single-arm Phase 2 trial suggest that fosmanogepix may be a safe, well-tolerated, and efficacious treatment for non-neutropenic patients with candidaemia, including those with renal impairment.The study was funded by Amplyx, now a subsidiary of Pfizer Inc.
Attribution-NonCommercial 4.0 International http://creativecommons.org/licenses/by-nc/4.0/ info:eu-repo/semantics/openAccess
Candidiasi - Tractament
Avaluació de resultats (Assistència sanitària)
Medicaments antifúngics - Ús terapèutic
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome
DISEASES::Bacterial Infections and Mycoses::Infection::Sepsis::Fungemia::Candidemia
Other subheadings::Other subheadings::Other subheadings::/drug therapy
CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Antifungal Agents
Other subheadings::Other subheadings::/therapeutic use
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento
ENFERMEDADES::infecciones bacterianas y micosis::infección::sepsis::fungemia::candidemia
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos::antifúngicos
Otros calificadores::Otros calificadores::/uso terapéutico
Clinical safety and efficacy of novel antifungal, fosmanogepix, for the treatment of candidaemia: results from a Phase 2 trial
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion