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Pharmacology

Therapeutic potential of Fosmanogepix (APX001) for intra-abdominal candidiasis: from lesion penetration to efficacy in a mouse model

Annie Lee, Ning Wang, Claire L. Carter, Matthew Zimmerman, Véronique Dartois, Karen Joy Shaw, David S. Perlin, Yanan Zhao
Annie Lee
aCenter for Discovery and Innovation, Hackensack Meridian Health, Nutley, NJ, USA
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Ning Wang
aCenter for Discovery and Innovation, Hackensack Meridian Health, Nutley, NJ, USA
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Claire L. Carter
aCenter for Discovery and Innovation, Hackensack Meridian Health, Nutley, NJ, USA
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Matthew Zimmerman
aCenter for Discovery and Innovation, Hackensack Meridian Health, Nutley, NJ, USA
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Véronique Dartois
aCenter for Discovery and Innovation, Hackensack Meridian Health, Nutley, NJ, USA
bDepartment of Medical Sciences, Hackensack Meridian School of Medicine, Nutley, NJ, USA
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  • ORCID record for Véronique Dartois
Karen Joy Shaw
cHearts Consulting Group, LLC, Poway, CA, USA.
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David S. Perlin
aCenter for Discovery and Innovation, Hackensack Meridian Health, Nutley, NJ, USA
bDepartment of Medical Sciences, Hackensack Meridian School of Medicine, Nutley, NJ, USA
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Yanan Zhao
aCenter for Discovery and Innovation, Hackensack Meridian Health, Nutley, NJ, USA
bDepartment of Medical Sciences, Hackensack Meridian School of Medicine, Nutley, NJ, USA
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  • ORCID record for Yanan Zhao
  • For correspondence: Yanan.zhao@hmh-cdi.org
DOI: 10.1128/AAC.02476-20
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ABSTRACT

Intra-abdominal candidiasis (IAC) is one of the most common yet underappreciated form of invasive candidiasis. IAC is difficult to treat, and therapeutic failure and drug resistant breakthrough infections are common in some institutions despite the use of echinocandins as first line agents. Fosmanogepix (FMGX, formerly APX001) is a first-in-class antifungal prodrug that can be administered both intravenously and orally. FMGX is currently in Phase 2 clinical development for the treatment of life-threatening invasive fungal infections. To explore the pharmacological property and therapeutic potential of FMGX for IAC, we evaluated both drug penetration and efficacy of the active moiety manogepix (MGX, formerly APX001A) in infected liver tissues in a clinically relevant IAC mouse model due to C. albicans. Matrix-assisted laser desorption ionization-mass spectrometry imaging (MALDI-MSI) and laser capture microdissection (LCM)-directed absolute drug quantitation were employed to evaluate drug penetration into liver abscess lesions both spatially and quantitatively. The partitioning of MGX into lesions occurred slowly after a single dose; however robust accumulation in the lesion was achieved after 3 days of repeated dosing. Associated with this drug penetration pattern, reduction in fungal burden and clearance in the liver were observed in mice receiving the multi-day FMGX regimen. In comparison, administration of micafungin resulted in marginal reduction in fungal burden at the end of 4 days of treatment. These results suggest that FMGX is a promising candidate for the treatment of IAC.

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Therapeutic potential of Fosmanogepix (APX001) for intra-abdominal candidiasis: from lesion penetration to efficacy in a mouse model
Annie Lee, Ning Wang, Claire L. Carter, Matthew Zimmerman, Véronique Dartois, Karen Joy Shaw, David S. Perlin, Yanan Zhao
Antimicrobial Agents and Chemotherapy Jan 2021, AAC.02476-20; DOI: 10.1128/AAC.02476-20

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Therapeutic potential of Fosmanogepix (APX001) for intra-abdominal candidiasis: from lesion penetration to efficacy in a mouse model
Annie Lee, Ning Wang, Claire L. Carter, Matthew Zimmerman, Véronique Dartois, Karen Joy Shaw, David S. Perlin, Yanan Zhao
Antimicrobial Agents and Chemotherapy Jan 2021, AAC.02476-20; DOI: 10.1128/AAC.02476-20
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