Systematic evaluation of the pre-eclampsia drugs, dietary supplements and biologicals pipeline using target product profiles.

Chloroquine Drug development Esomeprazole Hypertension L-Arginine Maternal medicine Metformin Pregnancy Sulfasalazine Vitamin D

Journal

BMC medicine
ISSN: 1741-7015
Titre abrégé: BMC Med
Pays: England
ID NLM: 101190723

Informations de publication

Date de publication:
04 11 2022
Historique:
received: 09 05 2022
accepted: 26 09 2022
entrez: 4 11 2022
pubmed: 5 11 2022
medline: 8 11 2022
Statut: epublish

Résumé

The Accelerating Innovation for Mothers (AIM) project established a database of candidate medicines in research and development (R&D) between 2000 and 2021 for five pregnancy-related conditions, including pre-eclampsia. In parallel, we published target product profiles (TPPs) that describe optimal characteristics of medicines for use in preventing/treating pre-eclampsia. The study objective was to use systematic double screening and extraction to identify all candidate medicines being investigated for pre-eclampsia prevention/treatment and rank their potential based on the TPPs. Adis Insight, Pharmaprojects, WHO international clinical trials registry platform (ICTRP), PubMed and grant databases were searched (Jan-May 2021). The AIM database was screened for all candidates being investigated for pre-eclampsia. Candidates in clinical development were evaluated against nine prespecified criteria from TPPs identified as key for wide-scale implementation, and classified as high, medium or low potential based on matching to the TPPs. Preclinical candidates were categorised by product type, archetype and medicine subclass. The AIM database identified 153 candidates for pre-eclampsia. Of the 87 candidates in clinical development, seven were classified as high potential (prevention: esomeprazole, L-arginine, chloroquine, vitamin D and metformin; treatment: sulfasalazine and metformin) and eight as medium potential (prevention: probiotic lactobacilli, dalteparin, selenium and omega-3 fatty acid; treatment: sulforaphane, pravastatin, rosuvastatin and vitamin B3). Sixty-six candidates were in preclinical development, the most common being amino acid/peptides, siRNA-based medicines and polyphenols. This is a novel, evidence-informed approach to identifying promising candidates for pre-eclampsia prevention and treatment - a vital step in stimulating R&D of new medicines for pre-eclampsia suitable for real-world implementation.

Sections du résumé

BACKGROUND
The Accelerating Innovation for Mothers (AIM) project established a database of candidate medicines in research and development (R&D) between 2000 and 2021 for five pregnancy-related conditions, including pre-eclampsia. In parallel, we published target product profiles (TPPs) that describe optimal characteristics of medicines for use in preventing/treating pre-eclampsia. The study objective was to use systematic double screening and extraction to identify all candidate medicines being investigated for pre-eclampsia prevention/treatment and rank their potential based on the TPPs.
METHODS
Adis Insight, Pharmaprojects, WHO international clinical trials registry platform (ICTRP), PubMed and grant databases were searched (Jan-May 2021). The AIM database was screened for all candidates being investigated for pre-eclampsia. Candidates in clinical development were evaluated against nine prespecified criteria from TPPs identified as key for wide-scale implementation, and classified as high, medium or low potential based on matching to the TPPs. Preclinical candidates were categorised by product type, archetype and medicine subclass.
RESULTS
The AIM database identified 153 candidates for pre-eclampsia. Of the 87 candidates in clinical development, seven were classified as high potential (prevention: esomeprazole, L-arginine, chloroquine, vitamin D and metformin; treatment: sulfasalazine and metformin) and eight as medium potential (prevention: probiotic lactobacilli, dalteparin, selenium and omega-3 fatty acid; treatment: sulforaphane, pravastatin, rosuvastatin and vitamin B3). Sixty-six candidates were in preclinical development, the most common being amino acid/peptides, siRNA-based medicines and polyphenols.
CONCLUSIONS
This is a novel, evidence-informed approach to identifying promising candidates for pre-eclampsia prevention and treatment - a vital step in stimulating R&D of new medicines for pre-eclampsia suitable for real-world implementation.

Identifiants

pubmed: 36329468
doi: 10.1186/s12916-022-02582-z
pii: 10.1186/s12916-022-02582-z
pmc: PMC9635102
doi:

Substances chimiques

Biological Products 0
Vitamin D 1406-16-2
Metformin 9100L32L2N

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

393

Informations de copyright

© 2022. The Author(s).

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Auteurs

Annie R A McDougall (ARA)

Maternal, Child and Adolescent Health Program, Burnet Institute, 85 Commercial Road, Melbourne, VIC, 3004, Australia. annie.mcdougall@burnet.edu.au.

Roxanne Hastie (R)

Department of Obstetrics and Gynaecology, University of Melbourne, Heidelberg, Australia.

Maya Goldstein (M)

Policy Cures Research, Sydney, Australia.

Andrew Tuttle (A)

Policy Cures Research, Sydney, Australia.

Stephen Tong (S)

Department of Obstetrics and Gynaecology, University of Melbourne, Heidelberg, Australia.

Anne Ammerdorffer (A)

Concept Foundation, Geneva, Switzerland.

A Metin Gülmezoglu (AM)

Concept Foundation, Geneva, Switzerland.

Joshua P Vogel (JP)

Maternal, Child and Adolescent Health Program, Burnet Institute, 85 Commercial Road, Melbourne, VIC, 3004, Australia.
School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.

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