Medicines for Malaria Venture (MMV) and Quotient Sciences have dosed the first participants in a Phase I trial of MMV371, a long-acting injectable (LAI) antimalarial drug. This trial marks a significant step in the development of a potential new tool for malaria prevention, particularly in vulnerable populations in malaria-endemic regions.
The Phase I, randomised, dose-escalation trial (NCT06558643) is being conducted at Quotient Science’s clinic in Nottingham, UK. The study will evaluate the safety, tolerability, and pharmacokinetics of MMV371 in 24 healthy participants divided into three cohorts. The first cohort will receive a starting dose of 112mg or placebo, the second will receive 223mg (double the starting dose), and the third will receive 446mg (double the second cohort dose), pending the safety and tolerability results from the preceding cohorts.
Potential for Quarterly Malaria Prevention
MMV371 is a derivative of atovaquone, an already approved antimalarial drug. As a long-acting injectable, MMV371 has the potential to provide up to three months of protection from malaria with a single intramuscular dose. This could significantly improve adherence compared to daily oral medications, especially in populations with limited access to healthcare.
Dr. Nand Singh, Medical Director at Quotient Sciences, stated, “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.”
Addressing Malaria Burden in Africa
Malaria remains a major public health problem, particularly in Africa. According to the World Health Organization (WHO), Africa accounted for 94% of malaria cases (233 million) and 95% (580,000) of malaria deaths in 2022. Children under five years of age are especially vulnerable, accounting for approximately 78% of all malaria deaths in the African region.
The WHO’s 2023 World Malaria Report indicated that there were 249 million malaria cases and 608,000 deaths globally in 2022, with sub-Saharan Africa bearing 95% of this burden. The development of new, effective malaria prevention tools like MMV371 is crucial to reducing this burden.
Future Development Plans
Pending positive outcomes from the current Phase I study, clinical trials of the LAI in malaria-endemic countries are expected to begin in 2026. The final injectable medicine is planned to be a fixed-dose combination of MMV371 and a suitable partner drug to reduce the likelihood of inducing resistant strains of malaria parasites. One potential partner drug is MMV055, another compound in MMV’s pipeline, which is expected to enter clinical development in 2025.
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. This highlights the ongoing efforts to develop and improve malaria treatments and preventative measures for all age groups.
