First-ever long-acting injectable for malaria prevention administered to study volunteers

First-in-human study explores a single injection that provides 3 months of protection

• This is the first clinical trial for Quotient Sciences and Medicines for Malaria Venture (MMV) of MMV371, a long-acting injectable.
• The injectable could offer up to 3 months of protection against all types of
• If successful in clinical trials, the final product has the potential to be a game changer, offering an affordable, long-lasting option to protect people of all ages from
• The trial is being administered at Quotient Sciences – Nottingham, UK clinic in healthy male and female

Nottingham, United Kingdom and Geneva, Switzerland. Medicines for Malaria Venture (MMV) and Quotient Sciences have begun the first clinical trial for a long-acting injectable (LAI) preventive compound for malaria. The trial, conducted in healthy volunteers in Nottingham, UK, marks a significant step toward preventing malaria in endemic regions.

According to the World Health Organization, 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. In this trial, MMV371, a derivative of atovaquone — already approved as part of atovaquone-proguanil (Malarone®), a medicine widely used by travellers to malaria-endemic areas — is being tested in an injectable form that could provide up to 3 months of protection with a single intramuscular dose.

First-in-human clinical trial

The trial 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 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.

An innovative approach to malaria prevention

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.

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. An LAI could be advantageous in regions where SMC campaigns cannot be deployed due to parasite resistance to the drugs currently used. “This trial brings us closer to our goal of offering a long-lasting, affordable solution for malaria prevention”, said Dr Stephan Chalon, Vice President of Experimental Medicine and Clinical Pharmacology at MMV.

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.”

Affordability and broad reach

With affordability a key requirement of its target product profile, the LAI is intended for all age groups, especially young and school-aged children, who are among the highest risk for malaria infection and death. The LAI’s affordability, single-dose administration and ability to prevent malaria cases and treat asymptomatic infections make it a potential game-changer for global malaria elimination efforts.