In 2019, MMV laid the foundations for a new initiative – Malaria in Mothers and Babies (MiMBa, meaning ‘pregnancy’ in the Swahili language) – which aims to address the needs of pregnant women and their newborn babies affected by malaria. Dr Wiweka Kaszubska tells us more.
1. How did the MiMBa initiative start out?
It was really a spontaneous movement among different experts from the MMV team, who started to ask what more we could do to ensure equitable access to medicines by pregnant women with malaria. We recognized that malaria elimination will not fully succeed without the intentional inclusion of women who are, or might become, pregnant. Even in the absence of supportive epidemiological data, it is easy to imagine that in Africa, pregnant women must represent a large proportion of the population that carry malaria parasites.
Currently, too few medicines can be safely used by pregnant women, particularly in the first trimester, and by women who might become pregnant. We formalized the MiMBa initiative and extended it to include women who are breastfeeding, and babies, thereby covering the whole continuum.
2. What does the MiMBa initiative aim to achieve?
In the near-term, we aim to fill data gaps on the use of current antimalarial medicines, which relate mostly to safety, but also to efficacy. In many cases, we don’t have the pharmacokinetic data to support the doses of currently-used antimalarials, which might need to be adjusted in women who are pregnant or who are breastfeeding.
There are also gaps on how to increase the coverage of antimalarials for these populations, so our APM1 team will conduct relevant operational research. As we develop new antimalarial medicines for the general population, the R&D team has the challenge of collecting data to help policymakers evaluate the risk–benefit profile of medicines for use in pregnant or lactating women.
3. What can MMV do to bring forward new medicines for pregnant women and babies?
MMV is operating within a broader movement rooted in gender equity to address gaps for pregnant women. Recognizing that gaps in adequately tolerated and effective therapies exist across all diseases, the US National Institutes of Health established a global task force (PRGLAC),2 which identifies the gaps in knowledge and research, and proposes recommendations that we intend to follow. A similar effort is underway by the European Innovative Medicines Initiative’s ConcePTION project.
MMV’s contribution is to bring malaria, a disease of the developing world, into this global movement. MMV’s drug discovery strategy already includes an early focus on admitting drug candidates to the development portfolio that have a promising safety profile for future use in pregnancy. To strengthen our approach to non-clinical studies, we plan to work even closer with our ESAC3 to select the most predictive in vitro and laboratory models, standardize interpretation of data, and ensure consistency in ranking and prioritization of compounds with a favourable profile.
MMV and partners are also establishing modelling approaches to predict if a compound is likely to cross the mother’s placenta, and how much of it might be found in her breast milk. Based on supportive data, it may be possible to conduct pharmacokinetic studies in pregnant women in parallel to Phase III development of a new drug, giving patients and physicians early and reliable information regarding its potential use during pregnancy.
4. Has the MiMBa initiative led to any specific projects yet?
We are establishing a pregnancy registry with the Liverpool School of Tropical Medicine, UK, covering several malaria-endemic countries in Africa. This multicentre, prospective, observational study will provide insights on the safety profile of a range of ACTs used during pregnancy in a real-world setting.
We plan to collect data on the health of mothers and babies in the next few years, to support evaluation of the benefit–risk profiles of selected ACTs and inform decision-making on their use, particularly in the first trimester of pregnancy.
With our long-standing partner, Novartis, MMV is also developing what could become the first medicine for the treatment of acute, uncomplicated malaria in neonates weighing under 5 kg. This is a new ratio of artemether plus lumefantrine (the components of Coartem Dispersible, p. 14), which we hope will enter clinical testing in 2021.4
1. Access & Product Management.
2. The Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC), was convened in response to US Congress legislation, the 21st Century Cures Act of 2016.This cross-cutting group, in consultation with the public, has produced 15 recommendations for the Secretary of Health and Human Services on how to close the gap in knowledge and research on well-tolerated and effective therapies for pregnant women and lactating women.
3. Expert Scientific Advisory Committee: an external body of experts that helps to identify the best projects worthy of inclusion in MMV’s portfolio and continues to monitor progress through an annual review of all projects.
4. Contract development in progress at the time of writing.