Potential Drug Development Candidates for Human Soil-Transmitted Helminthiases

BACKGROUND: Few drugs are available for soil-transmitted helminthiasis (STH); the benzimidazoles albendazole and mebendazole are the only drugs being used for preventive chemotherapy as they can be given in one single dose with no weight adjustment. While generally safe and effective in reducing int...

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Main Authors:	Olliaro, P., Seiler, J., Kuesel, A., Horton, J., Clark, J. N., Don, R., Keiser, J.
Format:	Journal Article
Language:	EN
Published:	2012
Subjects:	Aminoacetonitrile Animals Anthelmintics Depsipeptides Drug Approval Preclinical Drug Evaluation Europe Helminthiasis Animal Helminthiasis Humans Thiazoles United States
Online Access:	http://hdl.handle.net/10986/5119

id	okr-10986-5119
recordtype	oai_dc
spelling	okr-10986-51192021-04-23T14:02:21Z Potential Drug Development Candidates for Human Soil-Transmitted Helminthiases Olliaro, P. Seiler, J. Kuesel, A. Horton, J. Clark, J. N. Don, R. Keiser, J. Aminoacetonitrile Animals Anthelmintics Depsipeptides Drug Approval Preclinical Drug Evaluation Europe Helminthiasis Animal Helminthiasis Humans Thiazoles United States BACKGROUND: Few drugs are available for soil-transmitted helminthiasis (STH); the benzimidazoles albendazole and mebendazole are the only drugs being used for preventive chemotherapy as they can be given in one single dose with no weight adjustment. While generally safe and effective in reducing intensity of infection, they are contra-indicated in first-trimester pregnancy and have suboptimal efficacy against Trichuris trichiura. In addition, drug resistance is a threat. It is therefore important to find alternatives. METHODOLOGY: We searched the literature and the animal health marketed products and pipeline for potential drug development candidates. Recently registered veterinary products offer advantages in that they have undergone extensive and rigorous animal testing, thus reducing the risk, cost and time to approval for human trials. For selected compounds, we retrieved and summarised publicly available information (through US Freedom of Information (FoI) statements, European Public Assessment Reports (EPAR) and published literature). Concomitantly, we developed a target product profile (TPP) against which the products were compared. PRINCIPAL FINDINGS: The paper summarizes the general findings including various classes of compounds, and more specific information on two veterinary anthelmintics (monepantel, emodepside) and nitazoxanide, an antiprotozoal drug, compiled from the EMA EPAR and FDA registration files. CONCLUSIONS/SIGNIFICANCE: Few of the compounds already approved for use in human or animal medicine qualify for development track decision. Fast-tracking to approval for human studies may be possible for veterinary compounds like emodepside and monepantel, but additional information remains to be acquired before an informed decision can be made. 2012-03-30T07:31:23Z 2012-03-30T07:31:23Z 2011 Journal Article PLoS Negl Trop Dis 1935-2735 (Electronic) 1935-2727 (Linking) http://hdl.handle.net/10986/5119 EN http://creativecommons.org/licenses/by-nc-nd/3.0/igo World Bank Journal Article
repository_type	Digital Repository
institution_category	Foreign Institution
institution	Digital Repositories
building	World Bank Open Knowledge Repository
collection	World Bank
language	EN
topic	Aminoacetonitrile Animals Anthelmintics Depsipeptides Drug Approval Preclinical Drug Evaluation Europe Helminthiasis Animal Helminthiasis Humans Thiazoles United States
spellingShingle	Aminoacetonitrile Animals Anthelmintics Depsipeptides Drug Approval Preclinical Drug Evaluation Europe Helminthiasis Animal Helminthiasis Humans Thiazoles United States Olliaro, P. Seiler, J. Kuesel, A. Horton, J. Clark, J. N. Don, R. Keiser, J. Potential Drug Development Candidates for Human Soil-Transmitted Helminthiases
relation	http://creativecommons.org/licenses/by-nc-nd/3.0/igo
description	BACKGROUND: Few drugs are available for soil-transmitted helminthiasis (STH); the benzimidazoles albendazole and mebendazole are the only drugs being used for preventive chemotherapy as they can be given in one single dose with no weight adjustment. While generally safe and effective in reducing intensity of infection, they are contra-indicated in first-trimester pregnancy and have suboptimal efficacy against Trichuris trichiura. In addition, drug resistance is a threat. It is therefore important to find alternatives. METHODOLOGY: We searched the literature and the animal health marketed products and pipeline for potential drug development candidates. Recently registered veterinary products offer advantages in that they have undergone extensive and rigorous animal testing, thus reducing the risk, cost and time to approval for human trials. For selected compounds, we retrieved and summarised publicly available information (through US Freedom of Information (FoI) statements, European Public Assessment Reports (EPAR) and published literature). Concomitantly, we developed a target product profile (TPP) against which the products were compared. PRINCIPAL FINDINGS: The paper summarizes the general findings including various classes of compounds, and more specific information on two veterinary anthelmintics (monepantel, emodepside) and nitazoxanide, an antiprotozoal drug, compiled from the EMA EPAR and FDA registration files. CONCLUSIONS/SIGNIFICANCE: Few of the compounds already approved for use in human or animal medicine qualify for development track decision. Fast-tracking to approval for human studies may be possible for veterinary compounds like emodepside and monepantel, but additional information remains to be acquired before an informed decision can be made.
format	Journal Article
author	Olliaro, P. Seiler, J. Kuesel, A. Horton, J. Clark, J. N. Don, R. Keiser, J.
author_facet	Olliaro, P. Seiler, J. Kuesel, A. Horton, J. Clark, J. N. Don, R. Keiser, J.
author_sort	Olliaro, P.
title	Potential Drug Development Candidates for Human Soil-Transmitted Helminthiases
title_short	Potential Drug Development Candidates for Human Soil-Transmitted Helminthiases
title_full	Potential Drug Development Candidates for Human Soil-Transmitted Helminthiases
title_fullStr	Potential Drug Development Candidates for Human Soil-Transmitted Helminthiases
title_full_unstemmed	Potential Drug Development Candidates for Human Soil-Transmitted Helminthiases
title_sort	potential drug development candidates for human soil-transmitted helminthiases
publishDate	2012
url	http://hdl.handle.net/10986/5119
_version_	1764394016092192768

Potential Drug Development Candidates for Human Soil-Transmitted Helminthiases

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