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MORU. Photo: Mehul Dhorda.
Testing a single-formulation treatment combining artemether-lumefantrine and amodiaquine (ALAQ) developed by Fosun Pharma, the FD-TACT trial aims to provide an easy-to-administer treatment for adults, adolescents, and children over 6 months, to address the growing threat of resistance to artemisinins, the global frontline treatment for malaria. The first patient was enrolled on 11 Sept at the Ruhuha Health Centre in Rwanda, marking a significant milestone. The FD-TACT trial aims to enrol 1,600 patients, and is expected to be completed in Q2 2026.
The FD-TACT trial’s effort to combat rising antimalarial resistance using innovative drug combinations arises as artemisinin resistance, linked to mutations in the kelch13 gene, threatens malaria control, particularly in Africa, where malaria morbidity and mortality are highest. Estimates suggest that widespread resistance could lead to 16 million additional malaria cases and 360,000 hospitalized severe cases annually. This trial builds on MORU’s previous work to study antimalarial resistance patterns and develop strategies to maintain treatment efficacy through innovative use of existing antimalarial drugs.
The ALAQ combination combines widely accepted drugs – artemether-lumefantrine (AL) and amodiaquine (AQ) – known for their efficacy, safety, and tolerability. By combining these drugs into a single fixed-dose formulation, the treatment ensures proper dosing, improves adherence, and reduces the risk of incomplete cures that fuel resistance. This combination work aligns with the WHO’s 2022 Strategy to Respond to Antimalarial Drug Resistance in Africa, which emphasizes optimized medicine use and innovation.
Key benefits include:
- Proven Efficacy: Earlier studies, supported by MORU’s research, demonstrated that combining these drugs is highly effective, even in areas with high artemisinin resistance.
- Child-friendly formulation: The trial includes a dispersible formulation tailored for children, who account for nearly three-quarters of malaria deaths annually.
- Cost-effective solution: By using existing cheap drugs, this approach offers an affordable way to sustain effective treatment.
- Fixed-dose convenience: Patients take one to three tablets twice daily for three days, based on body weight, simplifying treatment regimens.
MORU’s role includes designing and overseeing the study, ensuring rigorous scientific standards, and coordinating with partner institutions across multiple countries in Rwanda (University of Rwanda), Uganda (Infectious Diseases Research Collaboration), Nigeria (Centre for Malaria and other Tropical Diseases), Angola (Instituto Nacional de Investigação em Saúde), and Thailand (Shoklo Malaria Research Unit, SMRU). The project is the result of a collaboration with Fosun Pharma, Medicines for Malaria Venture (MMV), and Marubeni Corporation.
This trial marks the first time a fixed-dose triple-drug combination has been tested in Phase 3, building on MORU’s earlier research that validated the efficacy of these drugs when used together.
“Triple ACTs could be key to ensuring that artemisinin resistance does not derail malaria control and elimination efforts in Africa,” said Dr Mehul Dhorda, Coordinator and Co-Principal Investigator of the FD-TACT trial at MORU.
Prof Arjen Dondorp, Co-PI and Deputy Director at MORU, added, “This Phase 3 trial represents a critical step toward delivering a practical, effective, and accessible treatment to save lives.”
- With thanks to Mehul Dhorda for text and photo.