The pipeline for drugs for control and elimination of neglected tropical diseases: 1. Anti-infective drugs for regulatory registration.

Autor: Pfarr KM; Institute of Medical Microbiology, Immunology and Parasitology, University Hospital Bonn, Bonn, Germany.; German Center for Infection Research, Partner Site Bonn-Cologne, Bonn, Germany., Krome AK; Department of Pharmaceutical Technology and Biopharmaceutics, University of Bonn, Bonn, Germany., Al-Obaidi I; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK., Batchelor H; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK., Vaillant M; Competence Center for Methodology and Statistics, Luxembourg Institute of Health, Strassen, Grand Duchy of Luxembourg., Hoerauf A; Institute of Medical Microbiology, Immunology and Parasitology, University Hospital Bonn, Bonn, Germany.; German Center for Infection Research, Partner Site Bonn-Cologne, Bonn, Germany., Opoku NO; Department of Epidemiology and Biostatistics School of Public Health, University of Health and Allied Sciences, Hohoe, Ghana., Kuesel AC; UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (WHO/TDR), World Health Organization, Geneva, Switzerland. kuesela@who.int.
Jazyk: angličtina
Zdroj: Parasites & vectors [Parasit Vectors] 2023 Mar 01; Vol. 16 (1), pp. 82. Date of Electronic Publication: 2023 Mar 01.
DOI: 10.1186/s13071-022-05581-4
Abstrakt: The World Health Organization 'Ending the neglect to attain the Sustainable Development Goals: A road map for neglected tropical diseases 2021-2030' outlines the targets for control and elimination of neglected tropical diseases (NTDs). New drugs are needed to achieve some of them. We are providing an overview of the pipeline for new anti-infective drugs for regulatory registration and steps to effective use for NTD control and elimination. Considering drugs approved for an NTD by at least one stringent regulatory authority: fexinidazole, included in WHO guidelines for Trypanosoma brucei gambiense African trypanosomiasis, is in development for Chagas disease. Moxidectin, registered in 2018 for treatment of individuals ≥ 12 years old with onchocerciasis, is undergoing studies to extend the indication to 4-11-year-old children and obtain additional data to inform WHO and endemic countries' decisions on moxidectin inclusion in guidelines and policies. Moxidectin is also being evaluated for other NTDs. Considering drugs in at least Phase 2 clinical development, a submission is being prepared for registration of acoziborole as an oral treatment for first and second stage T.b. gambiense African trypanosomiasis. Bedaquiline, registered for tuberculosis, is being evaluated for multibacillary leprosy. Phase 2 studies of emodepside and flubentylosin in O. volvulus-infected individuals are ongoing; studies for Trichuris trichuria and hookworm are planned. A trial of fosravuconazole in Madurella mycetomatis-infected patients is ongoing. JNJ-64281802 is undergoing Phase 2 trials for reducing dengue viral load. Studies are ongoing or planned to evaluate oxantel pamoate for onchocerciasis and soil-transmitted helminths, including Trichuris, and oxfendazole for onchocerciasis, Fasciola hepatica, Taenia solium cysticercosis, Echinococcus granulosus and soil-transmitted helminths, including Trichuris. Additional steps from first registration to effective use for NTD control and elimination include country registrations, possibly additional studies to inform WHO guidelines and country policies, and implementation research to address barriers to effective use of new drugs. Relative to the number of people suffering from NTDs, the pipeline is small. Close collaboration and exchange of experience among all stakeholders developing drugs for NTDs may increase the probability that the current pipeline will translate into new drugs effectively implemented in affected countries.
(© 2023. World Health Organization 2023.)
Databáze: MEDLINE
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