In vitro characterization, ADME analysis, and histological and toxicological evaluation of BM1, a macrocyclic amidinourea active against azole-resistant Candida strains.


Journal

International journal of antimicrobial agents
ISSN: 1872-7913
Titre abrégé: Int J Antimicrob Agents
Pays: Netherlands
ID NLM: 9111860

Informations de publication

Date de publication:
Mar 2020
Historique:
received: 16 07 2019
revised: 08 11 2019
accepted: 14 12 2019
pubmed: 24 12 2019
medline: 26 3 2020
entrez: 24 12 2019
Statut: ppublish

Résumé

Candida species are one of the most common causes of nosocomial bloodstream infections among the opportunistic fungi. Extensive use of antifungal agents, most of which were launched on the market more than 20 years ago, led to the selection of drug-resistant or even multidrug-resistant fungi. We recently described a novel class of antifungal macrocyclic compounds with an amidinourea moiety that is highly active against azole-resistant Candida strains. A compound from this family, BM1, was investigated in terms of in vitro activity against various Candida species, including C. auris isolates, interaction with the ABC transporter, CDR6, and in vivo distribution and safety. In vitro assays (CYP inhibition, microsomal stability, permeability, spot assays) were used to collect chemical and biological data; animal models (rat) paired with LC-MS analysis were utilised to evaluate in vivo toxicology, pharmacokinetics, and distribution. The current research shows BM1 has a low in vivo toxicity profile, affinity for the renal system in rats, and good absorption, distribution, metabolism, and excretion (ADME). BM1 also has potent activity against azole-resistant fungal strains, including C. auris isolates and CDR6-overexpressing strains. The results confirmed low minimum inhibitory concentrations (MICs) against several Candida species, including preliminary data vs. C. auris. BM1 has good ADME and biochemical characteristics, is suitable and safe for daily administration and is particularly indicated for renal infections. These data indicate BM1 and its derivatives form a novel, promising antifungal class.

Sections du résumé

BACKGROUND BACKGROUND
Candida species are one of the most common causes of nosocomial bloodstream infections among the opportunistic fungi. Extensive use of antifungal agents, most of which were launched on the market more than 20 years ago, led to the selection of drug-resistant or even multidrug-resistant fungi. We recently described a novel class of antifungal macrocyclic compounds with an amidinourea moiety that is highly active against azole-resistant Candida strains.
OBJECTIVE OBJECTIVE
A compound from this family, BM1, was investigated in terms of in vitro activity against various Candida species, including C. auris isolates, interaction with the ABC transporter, CDR6, and in vivo distribution and safety.
METHODS METHODS
In vitro assays (CYP inhibition, microsomal stability, permeability, spot assays) were used to collect chemical and biological data; animal models (rat) paired with LC-MS analysis were utilised to evaluate in vivo toxicology, pharmacokinetics, and distribution.
RESULTS RESULTS
The current research shows BM1 has a low in vivo toxicity profile, affinity for the renal system in rats, and good absorption, distribution, metabolism, and excretion (ADME). BM1 also has potent activity against azole-resistant fungal strains, including C. auris isolates and CDR6-overexpressing strains.
CONCLUSIONS CONCLUSIONS
The results confirmed low minimum inhibitory concentrations (MICs) against several Candida species, including preliminary data vs. C. auris. BM1 has good ADME and biochemical characteristics, is suitable and safe for daily administration and is particularly indicated for renal infections. These data indicate BM1 and its derivatives form a novel, promising antifungal class.

Identifiants

pubmed: 31866465
pii: S0924-8579(19)30336-X
doi: 10.1016/j.ijantimicag.2019.105865
pii:
doi:

Substances chimiques

Antifungal Agents 0
Azoles 0
guanidine carboxamide 141-83-3
Urea 8W8T17847W
Guanidine JU58VJ6Y3B

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

105865

Informations de copyright

Copyright © 2020. Published by Elsevier B.V.

Auteurs

Francesco Orofino (F)

Department of Biotechnology, Chemistry and Pharmacy, University of Siena, I-53100 Siena, Italy.

Giuseppina I Truglio (GI)

Department of Biotechnology, Chemistry and Pharmacy, University of Siena, I-53100 Siena, Italy.

Diego Fiorucci (D)

Department of Biotechnology, Chemistry and Pharmacy, University of Siena, I-53100 Siena, Italy.

Ilaria D'Agostino (I)

Department of Biotechnology, Chemistry and Pharmacy, University of Siena, I-53100 Siena, Italy.

Matteo Borgini (M)

Department of Biotechnology, Chemistry and Pharmacy, University of Siena, I-53100 Siena, Italy.

Federica Poggialini (F)

Department of Biotechnology, Chemistry and Pharmacy, University of Siena, I-53100 Siena, Italy.

Claudio Zamperini (C)

Lead Discovery Siena s.r.l., Via Vittorio Alfieri 31, I-53019 Castelnuovo Berardenga, Italy.

Elena Dreassi (E)

Department of Biotechnology, Chemistry and Pharmacy, University of Siena, I-53100 Siena, Italy.

Laura Maccari (L)

Lead Discovery Siena s.r.l., Via Vittorio Alfieri 31, I-53019 Castelnuovo Berardenga, Italy.

Riccardo Torelli (R)

Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Dipartimento di Scienze di Laboratorio e Infettivologiche, Rome, Italy.

Cecilia Martini (C)

Istituto di Microbiologia, Università Cattolica del Sacro Cuore, Rome, Italy.

Micaela Bernabei (M)

Istituto di Anatomia Patologica, Fondazione Policlinico Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.

Jacques F Meis (JF)

Department of Medical Microbiology and Infectious Diseases, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands; Radboud University Medical Center, Nijmegen, the Netherlands.

Nitesh Kumar Khandelwal (NK)

School of Life Sciences, Jawaharlal Nehru University, New Delhi, 110067, India.

Rajendra Prasad (R)

Amity Institute of Integrative Sciences and Health, Amity University, Gurgaon 122413, Haryana, India.

Maurizio Sanguinetti (M)

Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Dipartimento di Scienze di Laboratorio e Infettivologiche, Rome, Italy; Istituto di Microbiologia, Università Cattolica del Sacro Cuore, Rome, Italy.

Francesca Bugli (F)

Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Dipartimento di Scienze di Laboratorio e Infettivologiche, Rome, Italy; Istituto di Microbiologia, Università Cattolica del Sacro Cuore, Rome, Italy. Electronic address: francesca.bugli@unicatt.it.

Maurizio Botta (M)

Department of Biotechnology, Chemistry and Pharmacy, University of Siena, I-53100 Siena, Italy; Lead Discovery Siena s.r.l., Via Vittorio Alfieri 31, I-53019 Castelnuovo Berardenga, Italy; Sbarro Institute for Cancer Research and Molecular Medicine, Center for Biotechnology, College of Science and Technology, Temple University, BioLife Science Building, Philadelphia, PA 19122, USA.

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Classifications MeSH