Phase II multicenter clinical trial of a Ferroquine + MMV253 short regimen for the treatment of malaria (SINDOFO)

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.

Project details

Capacity Building
Drug-based Strategies

Jan 2021 — Jun 2025

$11M

Burkina Faso
Gabon
Germany
Kenya
Mozambique