Pushing to end the double neglect
Innovation to address the unmet needs of women and children
Neglected tropical diseases (NTDs) affect over a billion people worldwide – cutting lives short, trapping families in poverty, and causing immeasurable anguish, disability, and stigma.
Their impact is even more devastating for pregnant women and children, for whom treatments are frequently unavailable, unsuitable, or carry unacceptable risks.
DNDi is working to overcome this double neglect and prioritize women and children’s specific needs at every stage of the drug development process.
A gender-responsive R&D agenda
Too often, women are excluded from clinical trials that would provide essential sex-specific data on how drugs move through the body and on medicine safety during pregnancy and breastfeeding – ultimately limiting access to safe, effective treatments.
DNDi is working to include women in its clinical trials by ensuring our study protocols mandate their inclusion and that any exclusion is explicitly justified with a valid rationale. In 2024, 45% of patients enrolled in our active clinical trials were women.
For some NTDs, available treatments are known to cause harm to a developing embryo or foetus, prohibiting treatment during pregnancy and making treatment decisions especially difficult for women who are unable to use contraception due to access barriers or to personal, religious, or cultural factors. While we work towards finding safer treatments for women who are or may become pregnant, we are also joining with affected communities in Colombia and Kenya to understand barriers to the use of contraception during treatment with medications that could be harmful during pregnancy. Our mixed-method study – combining literature reviews with quantitative and qualitative research – began in Colombia in 2024 with the establishment of a community advisory committee, and quantitative research for the initiative was completed in Kenya.
Bernabe is living with Chagas disease, which can be passed from mother to child during pregnancy. She made a three-hour journey over difficult terrain in one of Colombia’s most remote regions to ensure her baby could be tested and, if needed, promptly treated. DNDi is working with Colombia’s Wiwa Indigenous community, Indigenous health authorities, and the Colombian government to boost access to Chagas testing and treatment.
A further consideration is the fact that gender-responsive R&D requires the full participation of women in medical and scientific leadership, yet women in these fields continue to face professional barriers. In November 2024, DNDi collaborated with WomenLift Health and the Public Health Foundation of India to host a comprehensive dialogue on gender-inclusive science, access, and leadership. Exploring the systemic challenges faced by women in health research and examining the urgent need for actionable strategies to address these disparities, the meeting assembled perspectives and insights from representatives of the Indian Council for Medical Research, Office of the Drugs Controller General of India, Office of the Principal Scientific Advisor, academic institutes, international organizations, and industry. Key recommendations included calls for gender-specific research to understand the unique impact of NTDs on women, empowerment of women researchers and health workers to drive gender-responsive agendas, and expansion of community engagement to enhance awareness of NTDs and ensure access to treatment.
Research to restore dignity
Female genital schistosomiasis (FGS) affects an estimated 30 to 56 million women and girls worldwide. This painful and stigmatizing disease can also cause lasting reproductive harm. Despite its prevalence, there is little awareness of FGS and women are often misdiagnosed – if at all. Current treatments using anthelminthic drugs do not reverse existing genital damage and often do little to relieve pain, lesions, and other chronic symptoms.
DNDi has joined the WINGS-4-FGS consortium in a four-year project that aims to increase community awareness, integrate FGS care into existing sexual and reproductive health strategies, and advance development of new treatments. Beginning in 2025, DNDi will support Malawi’s Kamuzu University of Health Sciences as they lead new proof-of-concept trial testing combination treatments that we hope can both alleviate painful symptoms and eliminate the parasite that causes FGS.
Innovating for children’s health
Globally, half a billion children are impacted by NTDs that can cause impaired cognitive development, stunted growth, malnutrition, physical disability or disfigurement, and social exclusion. Yet fewer than half of all treatments for NTDs are approved for use in children.
DNDi’s commitment to ending this neglect is rooted in our history. Since 2003, our teams have developed four affordable treatments for malaria, Chagas disease, and HIV specifically designed for children, as well as treatments for sleeping sickness and leishmaniasis proven suitable for both children and adults.
Today, DNDi’s Innovation for Children Programme continues our work to accelerate the development and delivery of safe, simple, affordable, child-adapted medicines and to advocate at the highest levels for the systemic changes needed to meet the needs of children with neglected diseases.
Together with our longtime pharmaceutical partner Sanofi and partners in the ACOZI-KIDS consortium, our teams have continued work to evaluate the paediatric safety and efficacy of our promising single-dose cure for sleeping sickness – acoziborole – recently completing trial recruitment of children weighing between 10 and 40 kilograms and aged between 1 and 14 years old (read more). Our Phase II trial of LXE408 for leishmaniasis (read more) in India, conducted in partnership with Novartis, has begun enrolling adolescent participants as we simultaneously work to develop a child-friendly formulation of the potential treatment.
For river blindness, DNDi continues work with the eWHORM consortium to initiate development of a child-friendly formulation of oxfendazole for use in clinical trials. We also joined the IVM-KIDS consortium in 2024 to work with partners on developing and testing a paediatric formulation of ivermectin for the prevention and treatment of multiple parasitic worm infections in young children (read more).
Following the launch of the first-ever WHO paediatric drug optimization (PADO) process for NTDs in 2023, DNDi continued work with allies in the Global Accelerator for Paediatric Formulations (GAP-f). In 2024, we co-led the creation of the GAP-f Paediatric Technology Hub, for which DNDi now serves as a strategic advisor on efforts to prioritize and enable technologies to deliver priority paediatric medicines tailored to children’s specific needs.
More 2024 highlights:
Photo credit: Neil Brandvold-DNDi
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