Every year, 125 million pregnancies around the world are at risk from malaria.¹ In Africa alone, approximately 10,000 women and 200,000 babies die annually as a consequence.² Pregnant women have an increased risk of life-threatening outcomes, including cerebral malaria or severe anaemia.³

To protect pregnant women living in areas of moderate-to-high malaria transmission, WHO recommends Intermittent Preventive Treatment in pregnancy (IPTp) by administering the drug sulfadoxine-pyrimethamine (SP)⁵. Unfortunately, IPTp coverage is low – only 24% of pregnant women in sub-Saharan Africa receive the minimum dose.⁴ In addition, there are worrying signs that SP’s chemopreventive efficacy may be undermined in the future by drug resistance.

In line with current WHO recommendations, MMV has supported the Roll Back Malaria Partnership’s Call to Action, an advocacy effort outlining specific actions by national health entities, donors, the pharmaceutical industry and civil society, to achieve greater access to and acceptance of IPTp where and while it is still effective. 

To address the need for more research on new IPTp options, MMV and the London School of Hygiene & Tropical Medicine are conducting a safety study of Eurartesim® (DHA-PQP) in pregnant women in Tanzania. Specifically, this study will closely evaluate the cardiac safety of DHA-PQP in this group, building on other phase IV safety research that MMV and partners have already conducted in non-pregnant patients. 

For treatment of malaria in pregnancy, WHO recommends artemisinin-based combination therapy (ACT) during the second and third trimesters,⁵ but additional data are needed to confirm their safety and tolerability during the first trimester. Additionally, the dose of different ACTs needed during pregnancy remains uncertain, given significant changes in the metabolism of expectant women during the first trimester. 

MMV is planning to establish a registry that tracks outcomes of pregnant women exposed to antimalarials to build a more robust evidence base on the impact of specific medicines on pregnancy and new-borns. The first step will be to establish this registry in Mozambique with the Manhiça Foundation. This initiative will follow women who receive DHA-PQP as part of a Mass Drug Administration pilot programme, if they discover they are pregnant in the 2-month period that follows. The data will enable us to better understand the safety and tolerability of DHA-PQP during pregnancy.

New antimalarial medicines that are well-tolerated in pregnancy are needed for both treatment and protection. While we cannot definitively predict which medicines will be suitable in pregnancy, we can identify, early on, which medicines would not be. Traditionally, preclinical studies to determine if a molecule has a safety signal in pregnancy are conducted in parallel with phase II studies. MMV has developed a strategy to move this testing forward so it is conducted in parallel with the first-in-human studies. 

“Malaria during pregnancy is a serious threat to maternal and neonatal health. The development of interventions for malaria control in this most vulnerable group is urgently needed. Given its position and mission, MMV has a strategic and fundamental role to play in addressing the unmet needs of malaria in pregnancy.”

-        Dr Clara Menéndez, Director of the Maternal, Child and Reproductive Health InitiativeISGlobal