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An estimated 125 million pregnancies around the world are at risk from malaria annually.[1] For both mother and baby, the disease is potentially life-threatening and babies that do survive are often born with low birth weight, which is associated with negative impact on development.[2] These mothers-to-be need medicines to both protect them from getting infected with malaria and to treat them should they fall ill. Yet, these needs remain inadequately addressed.Medicines for Malaria Venture (MMV) is working with partners to improve the quality of global supplies of the World Health Organization (WHO)-recommended medicine sulphadoxine-pyrimethamine (SP) for use as intermittent preventive treatment in pregnancy (IPTp). As a partner in the Unitaid-funded Jhpiego-led consortium TIPTOP, MMV is supporting improved coverage of SP for IPTp in Africa through community health workers by strengthening the supply side for WHO-prequalified SP. For women who become infected with malaria during pregnancy, WHO currently recommends artemisinin combination therapies (ACTs) for the treatment of malaria in the second or third trimesters, and quinine with the antibiotic clindamycin in the first trimester. Angela Kangulumais is a primary school teacher in Zambia. She is 6 months pregnant with her second child.  Angela is no stranger to malaria—she fell ill just before her first pregnancy and was treated with an ACT. Pregnant women at risk of malaria like Angela benefit from IPTp to protect themselves and their unborn babies from malaria. Photo: Medicines for Malaria VentureBased on meta-analyses comparing treatment outcomes using the ACT artemether-lumefantrine (AL) versus quinine in first trimester pregnancies and following a recommendation for policy change from an Expert Review Group, WHO is considering whether to recommend the use of all ACTs in all trimesters of pregnancy. That said, the data set regarding the use ACTs other than AL in the first trimester is comparatively small. MMV is working with the Liverpool School of Tropical Medicine’s Timika Research Facility in Indonesia to analyse historical data and to capture new evidence regarding the use of the ACT dihydroartemisinin-piperaquine (DHA-PQP) in the first trimester of pregnancy. These new analyses will contribute to the evidence base regarding safety and tolerability of this ACT during pregnancy.In addition to expanded use of ACTs for treatment in pregnancy, the malaria research community is also focused on exploring the use of DHA-PQP as a potential substitute for SP for IPTp in the future, should SP’s preventive efficacy decline. MMV is working with the London School of Hygiene and Tropical Medicine in Tanzania on a study to evaluate the cardiac safety of a single course of IPTp with DHA-PQP in pregnant women with and without asymptomatic infection.For the future, we are also looking at the medicines we have in development and how they might be used for 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. MMV thus focuses early on in its drug development process to identify molecules that may have an acceptable safety profile in pregnancy. This focus includes conducting standard embryo-foetal development studies in parallel with other non-clinical safety assessment or phase I studies. A favorable safety report early on means that these molecules could be prioritized for development. In addition, with MMV’s support, a review was carried out and published to help guide the prioritization of antimalarial drugs for development. It detailed 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 is helping to guide the development of next-generation antimalarial medicines that could have an appropriate safety profile in pregnant women. With our partners, MMV is committed to investigating all the avenues to improve pregnancy outcomes for women at risk of malaria. By focusing on protecting and treating pregnant women at risk, we safeguard two lives, not just one.[1] Dellicour S et al. “Quantifying the Number of Pregnancies at Risk of Malaria in 2007: A Demographic Study”. PLos Med; 7(1): e1000221 (2010).[2] Schantz-Dunn J & Nour NM. “Malaria and Pregnancy: a global health perspective”. Rev Obstet Gynecol; 2(3):186–192 (2009).[3] 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). 

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. An experimental drug, remdesivir, was shown to protect monkeys against infection with Nipah virus—an emerging pandemic threat for which there is no approved vaccine or cure. The only current treatment is a still experimental monoclonal antibody that was tested during an outbreak in India last year. Remdesivir is also being tested against the Ebola virus in the current outbreak in the Democratic Republic of Congo and has shown some effectiveness against Lassa fever, MERS coronavirus, and respiratory syncytial virus in other studies. In the new study performed by the National Institute of Allergy and Infectious Diseases (NIAID) and the Centers for Disease Control and Prevention, eight African green monkeys were given lethal doses of Nipah virus. The four monkeys who received intravenous remdesivir within 24 hours of infection and daily infusions for 12 days survived, while the four that did not died within eight days. If remdesivir wins approval, “it will give us an extra treatment that could be used relatively quickly,” said Emmie de Wit, a virologist at NIAID, noting that “the average person who reaches a hospital dies within two days, so it’s hard to protect them once they’re infected.” The next step is to test how long after infection the drug can be given and still cure the animals. Women make up just over half of the 35 million people living with HIV worldwide but are underrepresented in clinical trials of potential HIV treatments, cures, and vaccines. A 2016 study performed by amfAR, the Foundation for AIDS Research, found that women represented a mean of only 11 percent of HIV cure trials, 19 percent of antiretroviral drug trials, and 38 percent of vaccine studies. Despite the well-known differences in how the immune systems of men and women respond to the HIV infection and how women respond to some drug treatments, clinical trials continue to rely heavily on the participation of gay men in particular. Further complicating women’s participation in clinical trials is the US Food and Drug Administration’s (FDA) strict rules for including women of childbearing age, leaving most researchers to opt for the easy way out and just enroll men, collecting data from women only after the drug is on the market. As scientists continue to pursue cures for HIV in light of reports of the second patient cured of the infection, researchers must reckon with the longstanding obstacle of the lack of women in clinical trials. The FDA has authorized the first diagnostic test to detect Zika antibodies in human blood to be marketed in the United States. The diagnostic, known as ZIKV Detect 2.0 IgM Capture ELISA, detects the proteins produced by the body’s immune system when it tests for the Zika virus in blood. Though 18 other active tests to detect Zika exist, they have only been allowed under emergency use. This newly approved diagnostic test will only be usable by those with clinical signs and symptoms of Zika or on those who have traveled to regions with active Zika transmissions. FDA Acting Commissioner Ned Sharples noted that the marketing authorization of this Zika diagnostic demonstrates “FDA’s work to protect the public health in emergency response situations.”

Against a backdrop of mounting global health challenges, the 72nd World Health Assembly (WHA) convened last week, with politicians, philanthropists, business executives, and civil society leaders all descending upon Geneva. GHTC was on the scene—attending side events, technical briefings, and following the official agenda. Here are our top four takeaways from this year’s assembly:1. Universal Health Coverage (UHC) dominates WHA.Considered the theme of this year’s WHA and a core component of the platform of the World Health Organization (WHO) Director-General, UHC was a ubiquitous topic in Geneva as stakeholders prepare for the United Nations (UN) High-Level Meeting on UHC in September. Multiple side events and briefings focused on the topic with discussions yielding numerous calls to action from bolstering the inclusion of low- and middle-income country (LMIC) voices, to investing in community health workers, to making primary health care the central pillar of UHC. During the official WHA sessions, there was also strong consensus around the importance of leaving no one behind, equity in health, and a people-centric approach to UHC. The hotly anticipated zero draft of the Political Declaration of the High-level Meeting on UHC was also released last week. The draft is meant to serve as a baseline for members states who will ultimately endorse a political declaration at the high-level meeting this fall and reflects some of the feedback that civil society provided during the consultative process. The document features some encouraging language on health research and development (R&D): calling for improved availability, access, and affordability of quality medicines, vaccines, diagnostics, and other health technologies, and it encourages incentives for R&D, including stronger public-private partnerships. The draft also underlines the importance of investment in new health technologies.While the R&D community can be heartened by these inclusions, there are notable omissions. There was no direct mention of specific diseases affecting vulnerable populations in LMICs and no specific request or direct call for increased investment in R&D for new health tools.2. Contentious access debate at WHA ends with compromise resolution on drug and health product price transparency.Advocates anticipated that the access to medicines issue would be the one of the most contentious topics at this year’s WHA. They were right.After long and arduous negotiations which delayed the access to medicines session by several days, member states adopted a compromise resolution at WHA urging greater transparency on drug prices. The resolution calls on members to “take appropriate measures to publicly share information on the net prices of health products.” The most contentious element of the initial draft, which urged disclosure of R&D costs, particularly for clinical trials, was ultimately amended to feature language emphasizing the purely voluntary nature of those disclosures. While the resolution was celebrated as a landmark by the WHO Director-General, many member states were unhappy with the process, with Germany, the United Kingdom, and the United States expressing their discontent with the approach and timing.3. Ebola crisis keeps emergency preparedness at the top of the agenda.The worsening Ebola crisis in the Democratic Republic of the Congo loomed large at WHA, as tributes to health workers were featured throughout the proceedings. There was a common refrain during the week about the need for improved coordination in emergency preparedness between global actors and local communities, with many delegates from the global south, including WHO Director-General Dr. Tedros himself, emphasizing the importance of building trust and integrating community health workers in the process. From an R&D perspective, many stakeholders called for strengthening in-country capacity, including laboratory and clinical trial capacity, as an integral pillar of developing effective countermeasures.To better support member states in improving preparedness, WHO set up a new division specifically for emergency preparedness, as part of its reform process earlier this year, which will work in tandem with its existing workstreams on emergency response. WHO also welcomed the appointment of a UN emergency Ebola response coordinator to facilitate interagency activities. 4. Follow-up meeting to the UN High-Level meeting on Tuberculosis (TB) shows promise with accountability as key.Several sessions at WHA focused on the follow-up to previous political commitments, including the declaration from the UN High-Level Meeting on TB. It was encouraging to hear the United States, several members of the European Union, and a few other member states call for additional R&D to combat TB and underscore the need to develop new drugs and vaccines, scale up diagnostic capabilities, and invest in innovative technologies.WHO also released a multisectoral accountability framework to accelerate progress to end the TB epidemic, which was previously requested in 2018 by the WHA and the UN General Assembly. Several countries, including the United States, endorsed the framework during the official session, and WHO is looking to facilitate its adaptation and use by member states and their partners at country, regional, and global levels throughout 2019. This year’s WHA cemented the need for new approaches, partnerships, and models in order to deliver on many of the promises that were made as part of the 2030 agenda. The next few months will see a continuation of advances on the UHC agenda, movement on WHO reform, and implementation of newly adopted resolution and political commitments.