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STOP 2030: TOWARDS THE INTERRUPTION OF TRANSMISSION OF SOIL-TRANSMITTED HELMINTHS: PROMOTING IMPLEMENTATION OF RESEARCH RESULTS OF A FIXED-DOSE COMBINATION OF CO-FORMULATED IVERMECTIN AND ALBENDAZOLE

Project description

Improving STH treatment for 2030 goals

Soil-Transmitted Helminths (STHs) are parasitic worms that infect humans through contaminated soil, leading to significant health issues, especially in low-income areas. Despite mass drug administration campaigns, current treatments using benzimidazole have limitations, especially against certain parasites like Trichuris trichiura. The World Health Organization (WHO) has set a target to eliminate STH morbidity in children by 2030, but achieving this goal remains challenging. Enhanced strategies and more effective treatments are urgently needed. In this context, the EU-funded STOP2030 project addresses this need by developing a new fixed-dose combination tablet of albendazole and ivermectin. Through clinical trials in Ethiopia, Kenya, and Mozambique, alongside additional studies in Ghana and Kenya, the project aims to improve STH treatment.

Objective

Soil-Transmitted Helminths (STH) remain a significant public health problem with recognized obstacles for control and elimination with the current benzimidazole regimens in Mass Drug Administration (MDA) campaigns. Renewed targets from WHO for 2030 include elimination of STH morbidity in pre-school and school age children (PSAC & SAC), increased country governance and financial support and a strongyloidiasis control program; 2030 has also been targeted by WHO for controlling NTDs to attain the Sustainable Development Goals.

The current proposal aims at accelerating the implementation of an innovative health technology, a fixed-dose combination (FDC) tablet of co-formulated albendazole and ivermectin, with adequate safety and significantly superior efficacy against T. trichiura in a registrational randomized clinical trial. This trial is being conducted in Ethiopia, Kenya and Mozambique with the guidance of EMA and sponsored by EDCTP (STOP projects) with a Phase II trial completed and a Phase III currently recruiting.

This project, STOP2030, seeks to complement the results of the safety and efficacy trial with a field-based safety and effectiveness clinical study, acceptability studies in Ghana and Kenya, modelling and cost-effectiveness exercises. The resulting information will be consolidated to build a multidisciplinary package for policy making and WHO guidance with the support of advocacy and communication activities to reach stakeholders and maximize the exploitation and impact of the FDC for STH control and elimination.

The Consortium assembled to execute the STOP2030 proposal combines expertise in complementary fields from program assessment and implementation through Ministries of Health in sub-Saharan African countries, advocacy, state of the art technology, leadership in clinical research and a pharma that has shown commitment for generating access to drugs against NTDs and has recently obtained WHO prequalification for generic ivermectin.

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HORIZON-JU-RIA - HORIZON JU Research and Innovation Actions

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Call for proposal

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(opens in new window) HORIZON-JU-GH-EDCTP3-2022-01

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Coordinator

LABORATORIOS LICONSA SA
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 483 815,25
Address
MANUEL POMBO ANGULO 28
28050 Madrid
Spain

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Region
Comunidad de Madrid Comunidad de Madrid Madrid
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 483 815,25

Participants (5)

Partners (1)

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