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Open AccessReview

Fosmanogepix: A Review of the First-in-Class Broad Spectrum Agent for the Treatment of Invasive Fungal Infections

1
Hearts Consulting Group, LLC, Poway, CA 92064, USA
2
The Lundquist Institute for Biomedical Innovation at Harbor-University of California Los Angeles (UCLA) Medical Center, Torrance, CA 90502, USA
3
David Geffen School of Medicine at University of California, Los Angeles (UCLA), Los Angeles, CA 90095, USA
*
Authors to whom correspondence should be addressed.
J. Fungi 2020, 6(4), 239; https://doi.org/10.3390/jof6040239
Received: 29 September 2020 / Revised: 12 October 2020 / Accepted: 16 October 2020 / Published: 22 October 2020
(This article belongs to the Special Issue Antifungal Agents Recently Approved or Under Development)
Fosmanogepix is a first-in-class antifungal currently in Phase 2 clinical trials for the treatment of invasive fungal infections caused by Candida, Aspergillus and rare molds. Fosmanogepix is the N-phosphonooxymethylene prodrug of manogepix, an inhibitor of the fungal enzyme Gwt1. Manogepix demonstrates broad spectrum in vitro activity against yeasts and molds, including difficult to treat pathogens. Because of its novel mechanism of action, manogepix retains potency against many resistant strains including echinocandin-resistant Candida and azole-resistant Aspergillus. Manogepix is also active against pathogens that demonstrate intrinsic resistance to other drug classes, such as Scedosporium, Lomentospora prolificans, and Fusarium with variable activity against Mucorales. Fosmanogepix demonstrates significant in vivo efficacy in mouse and rabbit disseminated infection models due to C. albicans, C. glabrata, C. auris, C. tropicalis, Coccidioides immitis, and F. solani as well as pulmonary infection models of A. fumigatus, A. flavus, S.prolificans, S. apiospermum and Rhizopus arrhizus. Clinical trials demonstrated high oral bioavailability (>90%), enabling switching between fosmanogepix intravenous and oral formulations without compromising blood levels. Favorable drug-drug interaction, tolerability, and wide tissue distribution profiles are observed making fosmanogepix an attractive option for the treatment of invasive fungal infections. This systematic review summarizes the findings of published data on fosmanogepix. View Full-Text
Keywords: fosmanogepix; FMGX; APX001; manogepix; MGX; APX001A; Gwt1; antifungal; Candida; Aspergillus; rare mold fosmanogepix; FMGX; APX001; manogepix; MGX; APX001A; Gwt1; antifungal; Candida; Aspergillus; rare mold
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Shaw, K.J.; Ibrahim, A.S. Fosmanogepix: A Review of the First-in-Class Broad Spectrum Agent for the Treatment of Invasive Fungal Infections. J. Fungi 2020, 6, 239.

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