The University Hospital

Start of study for new malaria therapy

The combination of two drugs could play a decisive role in the fight against one of the most dangerous malaria pathogens.

Malaria is one of the deadliest infectious diseases in the world and continues to spread as a result of advancing climate change. The increase in resistances to common antimalarial drugs is exacerbating the situation and there is an urgent need to develop new treatments. As part of a new study, 36 participants from Central Africa who are asymptomatic carriers of the malaria parasite Plasmodium falciparum are to be treated with a novel combination therapy.

With around 247 million infections and around 619,000 deaths per year, malaria is one of the most serious global health threats, especially in the most affected regions of sub-Saharan Africa. Various drugs with different active ingredients are available for the treatment and prevention of malaria. However, their efficacy depends heavily on the region and the spread of resistant pathogens. 

The malaria parasite Plasmodium falciparum in particular has developed resistance to many different malaria therapies. It is one of the most dangerous pathogens that can infect humans and causes the most severe form of malaria, known as malaria tropica. It is widespread in many tropical and subtropical regions and is responsible for most deaths. Drugs such as artemisinin-based combination therapies (ACTs) are used to treat malaria tropica. 

Fast and powerful effect

The new ZYFER-1 study is part of the SINDOFO project coordinated by the Institute of Tropical Medicine, Travel Medicine and Human Parasitology at the University Hospital of Tübingen. The study is intended to evaluate the safety of a new combination therapy. The substances ZY19489 and Ferroquine are combined and administered once or twice as tablets. ZY19489 is an experimental antimalarial drug that has already shown a promising effect against malaria parasites in first clinical trials. Ferroquine belongs to the same group as the well-known antimalarial drug chloroquine, with the advantage of being efficacious against widespread chloroquine-resistant malaria strains. “By using the two antimalarial drugs in combination, we are taking advantage of their different mechanisms of action. We expect ZY19489 to have a rapid and strong effect in combating the parasites,” explains project coordinator PD. Dr. Jana Held the different modes of action of the combination preparation. Ferroquine, meanwhile, has a relatively long half-life and remains in the body for up to 40 days. “This holds great potential for a prophylactic effect after treatment.” If the combination therapy proves to be safe in adults, the efficacy of the therapy will be tested in a further study not only in adult malaria patients, but also in children and adolescents between the ages of five and 18. 

Testing on asymptomatic carriers 

The study is being conducted at the Centre de Recherches Médicales de Lambaréné (CERMEL) in Gabon in Central Africa, with the pharmaceutical company Zydus Lifesciences Limited as sponsor. On site in Gabon, researcher and physician Dr. Dearie Glory Okwu is leading the study team. The first study participant was given the therapy on August 30, 2024, and further participants are currently being recruited. Initially, only asymptomatic individuals will be included in the study, as the combination therapy is being given for the first time. CERMEL employees go to the villages, speak to the residents and carry out rapid tests for Plasmodium falciparum. If the test is positive, the people are invited to take part in the study. 

The ZYFER-1 study is the first study of the SINDOFO project, which is funded with 9.8 million euros by the European & Developing Countries Clinical Trials Partnership (EDCTP) and the European Union (EU). The aim is to develop a highly effective combination therapy for malaria. Four African, three European and one Asian partner are cooperating on the research project. The project is coordinated by PD. Dr. Jana Held. 

Expert: 

PD. Dr. Jana Held

Institute of Tropical Medicine, Travel Medicine and Human Parasitology