The not-for-profit medical research organization Drugs for Neglected Diseases initiative (DNDi) welcomes renewed commitment from Japan’s Global Health Innovative Technology Fund (GHIT Fund) to patients affected by eumycetoma, one of the world’s most neglected tropical diseases.
The GHIT Fund has awarded DNDi a JPY 296 million (EUR 2 million) grant for the period 2023-2025 to support the registration of fosravuconazole – a new, safe, effective, and easier-to-administer treatment for eumycetoma – and support the preparatory activities needed to facilitate patients’ access to this medicine in Sudan, where the disease is endemic.
Eumycetoma is the fungal version of mycetoma, a deadly infection caused by fungi or bacteria that slowly spreads to the skin, flesh, and bones, causing severe disability.
‘For decades, people affected by mycetoma have been largely ignored by medical research. Until now, the limited treatments available for eumycetoma showed poor efficacy, even after 12 months of treatment – very often leaving patients with amputation as their only option,’ said Dr Borna Nyaoke, Head of Mycetoma Programme at DNDi.
‘But we now have data from our clinical trial of a new treatment that shows promising results. We therefore express our deepest thanks to GHIT Fund, which has been one of the few international donors investing in finding solutions for patients affected by this devastating disease.’
DNDi implemented the world’s first randomized double-blind clinical trial for patients with eumycetoma in partnership with Eisai Co., Ltd. (Eisai), a Japanese pharmaceutical company, and the Mycetoma Research Center in Khartoum, Sudan. This study aimed to evaluate the safety and efficacy of a new oral treatment called fosravuconazole, which was discovered by Eisai and developed for a fungal nail infection named onychomycosis by Eisai and a partner company. Fosravuconazole was shown to also have potent in vitro activity against the most common of the causative agents of eumycetoma in Sudan, Madurella mycetomatis.
The recently completed trial showed that fosravuconazole had shown good cure rates and was well tolerated. Fosravuconazole is expected to be a significant improvement over existing treatments thanks to its weekly administration, good safety profile, and because it does not need to be taken with food or drink to be well absorbed by the body. Having alternative therapies for mycetoma at doctors’ disposal is also essential to tackling the disease.
The GHIT’s grant will support DNDi’s work to register this new treatment with regulatory authorities in Sudan and the preparatory activities needed to facilitate patients’ access to the medicine. GHIT has supported DNDi’s research and development projects for neglected tropical diseases (NTDs) since 2013, including for Chagas disease, visceral leishmaniasis, cutaneous leishmaniasis, and eumycetoma.
Mycetoma is among the most neglected of the NTDs prioritized in the World Health Organization’s 2021-2030 NTDs Road Map. Eumycetoma, the fungal version of the disease, was included in WHO’s list of fungal priority pathogens in 2022. It is typically associated with poor living conditions and affects people in rural areas with limited access to healthcare. The disfigurement and disability that eumycetoma causes can lead to stigma and social discrimination. Between 20 and 25 per cent of patients treated at the Mycetoma Research Center in Sudan are children.
Developing effective tools to control mycetoma is fundamental to achieving the United Nations Sustainable Development Goals (SDGs), especially SDG Target 3.3, which calls for ending the epidemics of NTDs and other infectious diseases by 2030. This project will provide a solution to critical mycetoma treatment gaps and address the needs of patients suffering from this woefully neglected disease.
Mycetoma is a chronic, slow-growing infection that comes in either bacterial (actinomycetoma) or fungal (eumycetoma) form. It is characterized by devastating deformities, disability, and high morbidity. It causes stigma and has a serious negative socio-economic impact on those affected. Because the disease has been historically neglected by medical research, the exact route of infection is yet unknown – and while mycetoma is endemic in many tropical and subtropical regions, there is only scant data on the disease’s incidence and prevalence. Treatment for eumycetoma, the fungal form of the disease, requires prolonged courses of ineffective, prohibitively expensive antifungals that have serious side effects, followed by extensive and often destructive surgery, including amputation.
The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit medical research organization that discovers, develops, and delivers safe, effective, and affordable treatments for neglected people. DNDi is developing medicines for sleeping sickness, leishmaniasis, Chagas disease, river blindness, mycetoma, dengue, paediatric HIV, advanced HIV disease, cryptococcal meningitis, and hepatitis C. Its research priorities include children’s health, gender equity and gender-responsive R&D, and diseases impacted by climate change. Since its creation in 2003, DNDi has joined with public and private partners across the globe to deliver twelve new treatments, saving millions of lives. dndi.org
Yoko Noda (DNDi Tokyo)
Phone: +81 90 7909 8967
Frédéric Ojardias (DNDi Geneva)
Phone: +41 79 431 6216
Photo credit: Lameck Ododo-DNDi