As per WHO, Africa was home to 94% of malaria cases (233 million) and 95% (580 000) of malaria deaths in 2022. Credit: nechaevkon via Shutterstock.

Medicines for Malaria Venture (MMV) and Quotient Sciences have dosed the first participants in a trial of MMV371, a long-acting injectable (LAI) for the prevention of malaria.

Taking place at Quotient Science’s clinic in Nottingham, UK, healthy participants are being administered with MMV371, a derivative of atovaquone that is already approved as Malarone (atovaquone-proguanil), as a LAI the companies state may provide up to three months of protection from malaria with a single intramuscular dose.

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The Phase I, randomised, dose-escalation trial (NCT06558643) will evaluate the drug’s safety, tolerability, and pharmacokinetics, with 24 participants split into three cohorts. In the first cohort, participants will receive the starting dose (112mg) or placebo, with the second cohort – pending safety and tolerability of dosing in cohort one – to receive double the starting dose (223mg), and the final cohort to receive double the cohort two dose (446mg).

Pending positive outcomes of the study, clinical trials of the LAI in malaria-endemic countries are expected to begin in 2026.

The final injectable medicine is set to be a fixed-dose combination of MMV371 and a suitable partner drug with an aim to reduce the likelihood of inducing resistant strains of malaria parasites. One potential partner drug is another compound in MMV’s pipeline, MMV055, which is expected to enter clinical development in 2025.

“We are pleased to support MMV with the clinical development of the antimalarial drug MMV371,” said Quotient Sciences medical director Dr Nand Singh. “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,” he added.

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Malaria is an infectious disease caused by plasmodium falciparum protozoa, which is transmitted by infected female Anopheles mosquitoes.

Malaria is mostly found in tropical countries, with African regions having a high burden of the disease. Children under five years of age accounted for approximately 78% of all malaria deaths in the African region, as per the World Health Organization (WHO).

WHO’s 2023 World Malaria Report found there were 249 million malaria cases and 608,000 deaths globally in 2022, with sub-Saharan Africa bearing 95% of this burden.

In April 2024, Novartis and MMV reported positive data from the Phase II/III CALINA trial of Coartem (artemether 5mg/lumefantrine 60mg) in babies weighing less than 5kg with acute uncomplicated malaria, with the Coartem formulation for infants and neonates meeting the primary pharmacokinetic (PK) endpoint in infants.