Funded by a USD 3.3m investment announced 14 Dec by the Global Health Innovative Technology (GHIT) Fund, the FD-TACT (Fixed Dose Triple Artemisinin-based Combination Therapy) trial will assess the safety and efficacy of a single pill, fixed dose of three antimalarial drugs (artemether, lumefantrine, and amodiaquine) in Angola, Nigeria, Rwanda, Uganda and Thailand.
The single pill will protect vital antimalarial drugs from drug-resistant malaria parasites, say the scientists involved.
Dr Mehul Dhorda, FD-TACT co-principal investigator, of the Mahidol Oxford Tropical Medicine Research Unit (MORU) in Bangkok, said: 'Combining the three antimalarial TACT drugs into one FDC tablet ensures that patients suffering from malaria receive the full dose required to treat their malaria effectively – and protects each of the component drugs of the TACT from falling to resistance, helping them to remain effective for longer.'
This new FDC aims to mitigate the impact of the urgent problem of antimalarial drug resistance, specifically the emergence of artemisinin resistance in Plasmodium falciparum that has now been detected in multiple African countries. Artemisinin resistance and associated resistance to other drugs used in combination as first-line therapies across Africa threaten to derail malaria control and eradication efforts. Recent modelling studies have shown that TACTs could be amongst the most effective interventions in reducing the burden of malaria, even in contexts where artemisinin resistance has already emerged.
Prof Arjen Dondorp, Head of Malaria at MORU and co-principal investigator for FD-TACT, said: 'In 2022, malaria caused 608,000 deaths - most of them were children less than five years old in Africa. It is imperative to act against the drug-resistant malaria that is rapidly emerging there before it leads to increased malaria cases and deaths. We are very grateful to the GHIT Fund for supporting this important work. It is crucial that we develop new easy-to-use treatments like FD-TACT that can combat increasing drug resistance in malaria and save lives by boosting malaria control and elimination efforts in endemic countries.'
Conducted by MORU in collaboration with Fosun Pharma, Medicines for Malaria Venture (MMV), Marubeni Corporation and partners in Angola, Nigeria, Rwanda, Uganda, and Thailand, the trial will conduct comprehensive safety assessments of the FD-TACT and compare its efficacy with the most widely used current antimalarial treatments in Africa and Asia.
The FD-TACT trial follows the United Kingdom’s Foreign and Commonwealth Development Office (FCDO)-supported DeTACT (Development of Triple Artemisinin Combination Therapies) and TRACII (Targeting Resistance to Artemisinin Collaboration II) studies, the first to demonstrate that TACTs were well tolerated and safe.
Recruitment for the FD-TACT trial will begin in early 2024. FD-TACT trial results will be combined with those from previous trials of TACTs to support applications to market the FDC in malaria endemic countries.