MMV is proud to be partnering in the trial of the first combination medicine being developed specifically to protect expectant mothers and their babies from malaria and other infections.
Together with Pfizer and London School of Hygiene and Tropical Medicine (LSHTM), MMV is developing a new combination therapy to improve the health of pregnant mothers and babies in countries plagued by malaria. The medicine contains a fixed-dose combination of azithromycin and chloroquine (AZCQ), two drugs which are known to be well tolerated even in the first few weeks of pregnancy, when the baby is most vulnerable. Azithromycin has been shown clinically to counteract the mechanisms of chloroquine resistance, and so the new combination will work even in parts of the world where chloroquine resistance is an issue. (In regions with up to 50% resistance to chloroquine, the combination cures malaria in 98% of patients.)1 As well as treating low level asymptomatic malaria, it also protects against reinfection. In addition, the azithromycin antibiotic will act to eliminate sexually transmitted infections (STIs) in the mother.
Sadly, malaria is a leading cause of death for pregnant women and their new-born babies in sub-Saharan Africa. According to new research, every year around 125 million pregnancies are at risk of malaria2 and as a consequence up to 200,000 babies die.3 Further hindering a baby’s chances of survival in sub-Saharan Africa are the presence of STIs, which are unfortunately commonplace in pregnant women. STIs are the number one cause of premature birth, which is the biggest cause of newborn death.4 The endpoint of our clinical study is therefore to see whether the treatment increases the chances of a healthy baby and a successful pregnancy, rather than simply its effect on malaria.
The new medicine will be given to the mother-to-be when she attends an antenatal clinic. Babies whose mothers have been protected in this way are healthier and weigh more at birth – helping them to get a good start in life.
A major clinical trial comparing AZCQ against sulfadoxine-pyrimethamine (SP) has now begun, with the first women recruited in Uganda. The plan is to enroll around 5,000 pregnant women in sites in Benin, Kenya, Tanzania and Malawi as well as Uganda. The goal of the trial is to show that AZCQ is better than SP at protecting mums and babies from the effects of malaria and STIs. The trial is expected to be completed in 2013. If all goes well the new medicine will be launched in Africa in 2014.
As well as showing that AZCQ is better than SP, one of the main goals of the trial is to check that it is well tolerated by mums and that their babies are born healthy. Safety concerns are even higher when two lives are at stake.
“Pregnant women and their newborns are extremely susceptible to malaria infections and urgently need new medicines. It’s really exciting to be involved in developing a therapy for them that will not only protect them from malaria but other infections too – AZCQ has the potential to really save the lives of the most vulnerable.” Dr Stephan Duparc, MMV’s Chief Medical Officer.
1. Nakornchai S, Konthiang P. Activity of azithromycin or erythromycin in combination with antimalarial drugs against multidrug-resistant Plasmodium falciparum in vitro. Acta Trop. 100(3):185-91 (2006).
4. Mullick S, Watson-Jones D, Beksinska M, Mabey D. Sexually transmitted infections in pregnancy: prevalence, impact on pregnancy outcomes, and approach to treatment in developing countries. Sex Transm Infect 81: 294-302 (2005).