Evidence map›Paper›PMID 37022196›Full record

Trial reportAntimicrobial agents and chemotherapy2023

Clinical Efficacy and Safety of a Novel Antifungal, Fosmanogepix, in Patients with Candidemia Caused by Candida auris

Jose A Vazquez, Peter G Pappas, Kenneth Boffard, Fathima Paruk, Paul A Bien, Margaret Tawadrous, Eric Ople, Pamela Wedel, Iwona Oborska, Michael R Hodges

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04148287 (An Open-Label Study to Evaluate the Efficacy and Safety of APX001 in Patients With Candidemia and/or Invasive Candidiasis Caused by Candida Auris), which is not on this map. Cited by 52 papers.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed
12.8field-weighted citation impact, top 1% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT04148287 phase2completednot on this map

An Open-Label Study to Evaluate the Efficacy and Safety of APX001 in Patients With Candidemia and/or Invasive Candidiasis Caused by Candida Auris

TypeinterventionalSponsorBasilea PharmaceuticaRan2019 to 2020Enrolled9ConditionsCandidemia, Invasive Candidiases, Candida InfectionArmsAPX001
3 · Its place in the literature

Who cites it

52 citing papers in PubMed, 67 citations in OpenAlex.

  1. Fosmanogepix for the Treatment of Invasive Mold Diseases Caused by Aspergillus Species and Rare Molds: A Phase 2, Open-Label Study (AEGIS).Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Trial
  2. Trial
  3. Trial
  4. Review
  5. Fosmanogepix Treatment for Coccidioidomycosis Under an Expanded Access Program.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Article
  6. Review
  7. Review
  8. New Perspectives on Antimicrobial Agents: Fosmanogepix.Antimicrobial agents and chemotherapy · 2026
    Review
  9. Manogepix demonstrates potentAntimicrobial agents and chemotherapy · 2026
    Article
  10. Review
  11. Article
  12. Article
  13. Microbiology and molecular biology reviews : MMBR · 2026
    Review
  14. Review
  15. Review
  16. Review
  17. Frontiers in cellular and infection microbiology · 2026
    Review
  18. Review
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 2 countries.

Jose A VazquezMedical College of Georgia, Augusta University, Augusta, Georgia, USA.
Peter G PappasUniversity of Alabama at Birmingham, Birmingham, Alabama, USA.
Kenneth BoffardMilpark Hospital, University of the Witwatersrand, Johannesburg, South Africa.
Fathima ParukSteve Biko Academic Hospital, University of Pretoria, Pretoria, South Africa.
Paul A BienAmplyx Pharmaceuticals Inc., San Diego, California, USA.
Margaret TawadrousPfizer Inc., Groton, Connecticut, USA.ORCID 0000-0002-6815-2647
Eric OpleAmplyx Pharmaceuticals Inc., San Diego, California, USA.
Pamela WedelAmplyx Pharmaceuticals Inc., San Diego, California, USA.
Iwona OborskaAmplyx Pharmaceuticals Inc., San Diego, California, USA.
Michael R HodgesAmplyx Pharmaceuticals Inc., San Diego, California, USA.
Amplyx Pharmaceuticals (United States) · USAugusta University · USPfizer (United States) · USSteve Biko Hospital · ZAUniversity of Alabama at Birmingham · USUniversity of the Witwatersrand · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Fosmanogepix (FMGX), a novel antifungal available in intravenous (IV) and oral formulations, has broad-spectrum activity against pathogenic yeasts and molds, including fungi resistant to standard of care antifungals. This multicenter, open-label, single-arm study evaluated FMGX safety and efficacy for treatment of candidemia and/or invasive candidiasis caused by Candida auris. Eligible participants were ≥18 years, with established candidemia and/or invasive candidiasis caused by C. auris, (cultured within 120 h [for candidemia] or 168 h [for invasive candidiasis without candidemia] with accompanying clinical signs) and limited treatment options. Participants were treated with FMGX (≤42 days; loading dose: 1000 mg IV twice daily [Day 1], followed by 600 mg IV once daily [QD]). Switching to oral FMGX 800 mg QD was permitted from Day 4. Primary endpoint was treatment success (survival and clearance of C. auris from blood/tissue cultures without additional antifungals) at the end of the study treatment (EOST), assessed by an independent data review committee (DRC). Day 30 survival was a secondary endpoint.

Indexed as

CandidemiaCandidiasis, InvasiveAntifungal AgentsCandida aurisCandidiasisFemaleHumansIsocyanatesMaleMicrobial Sensitivity TestsTreatment OutcomeAntifungal AgentsIsocyanatesmethyl isocyanateAPX001Candida auriscandidemiafosmanogepixGwt1 inhibitorintensive care unit

Identifiers

PMID37022196
PMCPMC10190264
OpenAlexW4362658239

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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 OpenQuestion graph.