The clinical phase 1b trial was announced from Geneva and Kigali, according to MMV. The compound being tested is MMV371. The plan is to enrol approximately 80 healthy participants aged between 12 and 50 from an area with moderate malaria transmission in Rwanda. MMV Chief Executive Martin Fitchet said long-acting injections had the potential to provide sustained protection through a single administration and expand prevention options for communities at risk.
What the trial in Rwanda is intended to test
The planned investigation, according to the trial registration on ClinicalTrials.gov, focuses on the safety, tolerability and pharmacokinetics of a single MMV371 injection in healthy adults and adolescents; pharmacokinetics measures drug levels in the body. An exploratory endpoint will also assess whether participants are protected against malaria while MMV371 remains in the body. Before the injection, participants receive an approved standard treatment with artemether-lumefantrine to clear existing malaria infections before the study drug is injected into a muscle in the upper arm, thigh or hip. The trial is designed to be placebo-controlled and double-blind: Three out of four participants receive MMV371, and one quarter receive a placebo. Neither the participants nor the researchers treating them know who has received which substance until the trial ends. Participation is expected to last up to 7 months, with frequent follow-up visits through week 24 to monitor safety, drug levels and possible malaria infections; the primary endpoint is safety and tolerability, including the frequency of treatment-emergent adverse events, serious adverse events and injection-site reactions.
Where the compound comes from
According to Scripps Research, the starting compound was discovered at the Calibr-Skaggs Institute for Innovative Medicines, which selected atovaquone because it is an already approved malaria drug with favourable safety, tolerability and chemical properties; MMV subsequently developed the compound further into MMV371 with support from Janssen Pharmaceuticals. Initial clinical experience with MMV371 comes from a study conducted in 2024 at Quotient Sciences in Nottingham in the United Kingdom involving healthy male and female volunteers, which assessed the compound's safety, tolerability and pharmacokinetics. According to the Health Research Authority, the compound was administered there safely and was well tolerated at single doses of up to 446 mg in a total of 18 volunteers; in the highest dose group tested, at 669 mg, 2 of 24 participants experienced temporary, reversible grade 3 injection-site reactions in the form of swelling or nodules. This British study also showed the potential for approximately three months of protection, which the current trial in Rwanda builds on. In an animal model, one injection kept drug levels above the effective concentration for 69 days, according to Scripps Research, compared with 21 days after an injection of atovaquone alone.
In comparison
Preventive tools already in use each have their own limitations: The two malaria vaccines currently in use are intended for very young children, require four doses and provide partial protection. Preventive medication used in endemic areas must be taken monthly throughout the malaria season, which is difficult to adhere to according to Scripps Research, with missed doses allowing resistance to develop. According to WHO figures reported by Capital FM, malaria caused more than 280 million cases and over 600,000 deaths worldwide in 2024, with around 95 percent of deaths occurring in Africa. In the assessment of El Gaaloul and co-authors in 2024, future preventive drugs should demonstrate high and long-lasting protection with acceptable safety, while dosage form and cost must help support adherence under everyday conditions. The ClinicalTrials.gov registry entry maintained by MMV last listed the status as “not yet recruiting” in April 2026 and estimated that the trial would begin in September 2026; MMV itself announced the launch on 2 November 2026.
Conditions before the trial leads to a drug
¶ According to Capital FM, the trial is intended to establish whether the safety and tolerability results observed in Britain are replicated in participants in malaria-endemic Rwanda. On 28 October 2024, Quotient Sciences identified affordability as a central requirement of the target product profile; the injection was intended for all age groups, particularly young and school-age children, who are among the groups most at risk.