2026-04-17T07:35:35Zhttps://recercat.cat/oai/request

oai:recercat.cat:11351/104312025-10-24T08:47:37Zcom_2072_378070com_2072_378040com_2072_378071col_2072_378092col_2072_378097

00925njm 22002777a 4500 dc Pappas, Peter G. author Vazquez, Jose A. author Oren, Ilana author Rahav, Galia author aoun, mickael author Bulpa, Pierre author Ferrer, Ricard author 2023-10-11T12:21:59Z 2023-10-11T12:21:59Z 2023-10 Safety; Antifungal; Candidaemia Seguridad; Antifúngico; Candidemia Seguretat; Antifúngic; Candidèmia Background 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. http://hdl.handle.net/11351/10431 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