Malaria infection during pregnancy is a significant public health problem with substantial risks for the pregnant woman, her foetus and the new-born child. Annually, around 125 million pregnancies around the world are at risk from malaria.1 Pregnant women with malaria face an increased risk of life-threatening outcomes, including cerebral malaria or severe anaemia, as well as unfavourable pregnancy outcomes such as miscarriages, premature delivery and low-birth-weight babies.2
MMV is seeking to prioritize the development of drugs safe for use in pregnant women.
Traditionally, most drugs are tested for safety in pregnancy quite late in development (if at all), since in many therapeutic areas a product that cannot be used in pregnancy can still have enormous therapeutic value. However, in the case of malaria, the needs of pregnant women are clear and compelling. Therefore, MMV’s strategy is to identify, as early as possible in development, molecules that might have an acceptable safety profile in pregnancy. This means doing the standard embryo-foetal development studies in parallel with other non-clinical safety assessment or phase I studies. A favourable safety report early on means that these molecules can be prioritized for development.
In addition, with MMV’s support and to help guide the prioritization of drugs for development, a recent review was carried out and published detailing the non-clinical safety of all non-artemisinin antimalarial drugs.3 The article summarized data that was previously not easily accessible to health experts and will help guide the development of next-generation antimalarial medicines that could have an appropriate safety profile in pregnant women.
Dellicour S et al. “Quantifying the Number of Pregnancies at Risk of Malaria in 2007: A Demographic Study”. PLos Med; 7(1): e1000221 (2010).
Schantz-Dunn J & Nour NM. “Malaria and Pregnancy: a global health perspective”. Rev Obstet Gynecol; 2(3):186–192 (2009).
Clark RL. “Animal Embryotoxicity Studies of Key Non-Artemisinin Antimalarials and Use in Women in the First Trimester.” Birth Defects Res. 109(14):1075-1126 (2017).