IVM-KIDS · Accelerating a paediatric formulation of ivermectin for the control of Neglected Tropical Diseases

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.