A first-in-human study that is exploring a single, long-acting injection that provides three months of protection against all types of malaria, has been administered to study volunteers.
This is the first clinical trial for Quotient Sciences and Medicines for Malaria Venture (MMV).
If successful in clinical trials, the final product has the potential to offer an affordable, long-lasting option to protect people of all ages from malaria.
The trial is being administered at Quotient Sciences, Nottingham, UK clinic in healthy male and female volunteers and is evaluating the drug’s safety, tolerability and pharmacokinetics, or how the body interacts with the medicine. The final injectable medicine will be a fixed-dose combination of MMV371 and a suitable partner drug – a strategy that reduces the likelihood of inducing resistant strains of malaria parasites. Another compound in MMV’s pipeline, MMV055, is a potential partner drug candidate and is expected to enter clinical development in 2025.
The study is also evaluating different dose levels of MMV371 in adult volunteers. If approved, this new product could potentially play a key role in protecting against new infections from all malaria parasite species, including the two most common strains, Plasmodium vivax and Plasmodium falciparum, the most deadly form of malaria.
The new drug combination could also potentially clear asymptomatic malaria infections, a condition in which malaria parasites are present in the blood, but no symptoms appear. Addressing asymptomatic malaria is an important element of malaria elimination strategies as individuals who are infected but have no disease symptoms are unlikely to seek treatment, therefore contributing to ongoing disease transmission. Over time, this unchecked transmission can lead to the emergence and spread of drug-resistant malaria as the parasite is continuously exposed to various antimalarial drugs used in symptomatic individuals.
According to the World Health Organisation (WHO), in 2022, there were 249 million malaria cases and 608,000 deaths globally with sub-Saharan Africa bearing 95% of this burden. Innovations in malaria prevention are essential to respond to this ongoing public health crisis.
Pending positive outcomes of the study, clinical trials in malaria-endemic countries are expected to begin in 2026. The final product could be a vital tool suitable for broad populations and multiple malaria strains, with the potential to complement existing interventions such as vaccines; seasonal malaria chemoprevention (SMC), a highly effective preventive oral intervention administered mainly to children under 5; and ideally, intermittent preventive treatment of malaria in pregnancy.
Dr Stephan Chalon, Vice President of Experimental Medicine and Clinical Pharmacology at MMV said: “This trial brings us closer to our goal of offering a long-lasting, affordable solution for malaria prevention.”
Dr Nand Singh, Medical Director at Quotient Sciences, said: “We are pleased to support MMV with the clinical development of the antimalarial drug MMV371. The potential to help protect against P. vivax and P. falciparum strains and help save human lives is something that we are proud to be part of. This project will provide the scientific evidence for the potential development of long-acting injectable anti-malarial treatment.”
