Last Updated: 05/07/2024
Phase II multicenter clinical trial of a Ferroquine + MMV253 short regimen for the treatment of malaria (SINDOFO)
Objectives
The SINDOFO project main goal is to develop a new non-ACT-based antimalarial drug combination with a shortened, ideally single dose regimen to help reduce morbidity and mortality due to malaria in adults, adolescents, and most importantly, in children in Africa under the age of 5, who are the most vulnerable group with the highest number of deaths (2/3 of malaria deaths in 2019).
Specifically to assess the safety and efficacy of a ferroquine (FQ) + MMV253 combination at 4 African sites Gabon, Mozambique, Kenya and Burkina Faso.
Each African trial site and the University of Tübingen will take on a postdoc and a PhD student for capacity building. This will allow to qualify and further support African research and leadership at these sites.
Medical Research Center Lambarene (CERMEL), Gabon
National Center for Scientific and Technological Research (CNRST) Mali, Mali
Strathmore University (SU), Kenya
Manhiça Health Research Centre (CISM), Mozambique
Barcelona Institute for Global Health (ISGlobal), Spain
Medicines for Malaria Venture (MMV), Switzerland
A simplified regimen, ideally a single-day cure, of uncomplicated malaria would be the magic bullet in the antimalarial armamentarium. Improving treatment adherence is one of the key factors in reducing mortality and morbidity and also transmission of malaria, and such a regimen would substantially increase adherence.
Previous clinical trial has shown that ferroquine (FQ) has a great potential as combination partner in the single dose or short antimalarial regimen combination therapy. In addition, it presents favourable CMC (chemistry, manufacturing and controls) characteristics.
The two new compounds are FQ a next generation 4-aminoquinoline and MMV253, a triaminopyrimidine. Both compounds show unique features in terms of long half-life, and activity against current drug resistant strains.
The proposed study is a phase II, randomized, open label, trial, to assess the efficacy and safety of an oral formulation of FQ+MMV253 given in a short regimen (single dose, or two-day dose regimen on two consecutive days) in comparison with the standard of care in African adult and paediatric patients with uncomplicated Plasmodium falciparum malaria.
When safety and efficacy of a dose regimen in patients above 12 years has been established, an age step-down will be done, also including children below the age of five years, as they are the target population carrying the highest burden of disease. The trial will follow an adaptive study design.
Jan 2021 — Jun 2025
$11M
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