Is the New Malaria Monoclonal Antibody Safe and More Effective?

Synopsis
Key Takeaways
- MAM01 is a new monoclonal antibody for malaria.
- It is safe and well-tolerated.
- Provides protection to malaria-naive individuals.
- Demonstrated effectiveness in a controlled trial.
- Could redefine malaria prevention strategies.
New Delhi, Sep 25 (NationPress) A recently developed monoclonal antibody for malaria has proven to be safe, well-tolerated, and capable of providing protection to individuals without prior exposure to the malaria-causing parasite, as revealed in a new study.
The phase 1 randomized controlled trial investigating the experimental monoclonal antibody MAM01, published in the journal The Lancet Infectious Diseases, indicated that among the three malaria-naive adults who received the highest dose, none exhibited parasites in their bloodstream up to 26 weeks later.
The term “malaria-naive” describes individuals who have never encountered the malaria parasite, hence lack natural immunity to the disease.
“While new vaccines exist, their protective efficacy is not optimal. Monoclonal antibodies targeting the Plasmodium falciparum circumsporozoite protein could potentially simplify prevention efforts,” stated corresponding author Prof Kirsten E Lyke, from the Center for Vaccine Development and Global Health at the University of Maryland.
“MAM01 displayed excellent tolerability, met safety benchmarks, and demonstrated clinical proof-of-concept by providing protection to malaria-naive adults through the controlled human malaria infection model,” Lyke added.
According to statistics from the World Health Organization (WHO), malaria impacted approximately 263 million individuals globally and resulted in 597,000 fatalities in 2023, with children under five being particularly at risk, constituting the highest percentage of malaria-related deaths.
The research team assigned 37 malaria-naive adults aged between 18 and 50 years to receive either a single dose of MAM01 or a placebo from August 2023 to December 2024.
The administration of MAM01 was well-received, with no serious adverse events linked to the treatment occurring after one or two doses.
After exposure, all six participants in the control group, as well as 18 out of 22 individuals in the MAM01 group, exhibited malaria parasites in their blood.
However, “none of the three participants receiving the 40 mg/kg intravenous dose developed parasitaemia. Pharmacokinetic analysis revealed that serum MAM01 concentrations exceeding 88 micrograms/mL conferred protection against malaria challenges,” according to the researchers.