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Accelerating a paediatric formulation of ivermectin for the control of Neglected Tropical Diseases

Project description

A child-friendly treatment for tropical diseases in Africa

Ivermectin is vital for controlling neglected tropical diseases (NTDs). However, children weighing under 15 kg do not receive treatment due to a lack of safety data and appropriate formulations. A WHO report highlighted the urgent need for a paediatric-friendly ivermectin formulation for children. The EU-funded IVM-KIDS project will conduct studies to demonstrate the safety, pharmacokinetics, and efficacy of a new orodispersible formulation of ivermectin designed specifically for paediatric use. A safety study will take place across West, Central, East, and Southern Africa to evaluate its effectiveness against soil-transmitted helminthiasis. The project will work with European and African regulators to provide the necessary data to bring this treatment to market and improve access to effective therapies.

Objective

Ivermectin is a critical drug for the control and elimination of multiple neglected tropical diseases. Currently, children weighing under 15kg do not receive treatment with ivermectin due to an absence of safety data and the lack of a suitable paediatric formulation. Consequently, these children are left untreated. This results in considerable morbidity at the individual level and a reservoir of infection at the population level. These issues create a critical barrier to achieving the goals of the 2030 NTD roadmap.

In 2023, the World Health Organization (WHO) conducted a Paediatric Drug Optimisation (PADO) review to identify critical needs for therapeutics in children affected by NTDs. Recognising the central role of ivermectin in the control of NTDs, along with the opportunity to accelerate progress by expanding treatment to paediatric populations, this report highlighted a paediatric-friendly ivermectin formulation as as a critical priority for NTD programmes worldwide.

A novel orodispersible formulation of ivermectin provides the opportunity to address this critical gap. Our consortium brings together leading academic and drug development partners across Europe and sub-Saharan Africa to address this global priority need, with crucial experience in novel therapeutics and navigating the European and African regulatory landscapes.

Our consortium will deliver studies to demonstrate the safety, pharmacokinetics and efficacy of the novel, orodispersible formulation of ivermectin suitable for use in young children. This will include conducting a large safety study across West, Central, East and Southern Africa to demonstrate the efficacy of this agent for the treatment of soil transmitted helminthiasis.

We will work closely with European and African regulators to ensure that our project delivers both the scientific and regulatory data required to bring this agent to market and transform access to effective NTD treatment for for millions of children worldwide.

Fields of science (EuroSciVoc)

Keywords

Programme(s)

Topic(s)

Funding Scheme

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

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Call for proposal

(opens in new window) HORIZON-JU-GH-EDCTP3-2024-01-two-stage

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Coordinator

LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE ROYAL CHARTER
Net EU contribution
€ 1 721 785,00
Address
KEPPEL STREET
WC1E 7HT London
United Kingdom
Region
London Inner London — West Camden and City of London
Activity type
Higher or Secondary Education Establishments
Links
Total cost
€ 1 721 785,00

Participants (6)

Partners (2)