A Holistic Review of the Preclinical Landscape for Long-Acting Anti-infective Drugs Using HIV as a Paradigm.
antiretroviral
in vitro models
long-acting
preclinical
Journal
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
ISSN: 1537-6591
Titre abrégé: Clin Infect Dis
Pays: United States
ID NLM: 9203213
Informations de publication
Date de publication:
21 11 2022
21 11 2022
Historique:
entrez:
21
11
2022
pubmed:
22
11
2022
medline:
24
11
2022
Statut:
ppublish
Résumé
Lack of predictive preclinical models is a key contributor to the steep attrition rate in drug development. Successful clinical translation may be higher for new chemical entities or existing approved drugs reformulated for long-acting (LA) administration if preclinical studies designed to identify any new uncertainties are predictive of human exposure and response. In this review, we present an overview of standard preclinical assessments deployed for LA formulations and delivery systems, using human immunodeficiency virus LA therapeutics preclinical development as a paradigm. Key progress in the preclinical development of novel LA antiretrovirals formulations and delivery systems are summarized, including bispecific broadly neutralizing monoclonal antibody and small molecule technologies for codelivery of multiple drugs with disparate solubility properties. There are new opportunities to take advantage of recent developments in tissue engineering and 3-dimensional in vitro modeling to advance preclinical modeling of anti-infective activity, developmental and reproductive toxicity assessment, and to apply quantitative modeling and simulation strategies. These developments are likely to drive the progression of more LA anti-infective drugs and multipurpose technologies into clinical development in the coming years.
Identifiants
pubmed: 36410386
pii: 6835722
doi: 10.1093/cid/ciac685
pmc: PMC10200324
doi:
Substances chimiques
Anti-Infective Agents
0
Types de publication
Review
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
S490-S497Subventions
Organisme : Wellcome Trust
Pays : United Kingdom
Organisme : NIAID NIH HHS
ID : R01 AI134091
Pays : United States
Organisme : NIAID NIH HHS
ID : R24 AI118397
Pays : United States
Organisme : NIH HHS
ID : R24 AI 118397
Pays : United States
Informations de copyright
© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
Déclaration de conflit d'intérêts
Potential conflicts of interest. A. Owen is a Director of Tandem Nano Ltd and co-inventor of patents relating to drug delivery. A. Owen has received research funding from ViiV Healthcare, Merck, and Janssen and consultancy from Gilead, GSK, Tandem Nano Ltd, and ViiV Healthcare. Funding from ViiV Healthcare and Merck is not related to the current work. A. Olagunju reports research funding from the Wellcome Trust from 2017-2020 204776/Z/16/Z. M. N. reports patent NRTI Therapies EFS ID:34668087.
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