DNDi is pleased to announce its 2024 Projects of the Year, which recognize DNDi teams and partners for outstanding progress in pre-clinical and clinical research. Nominated by the DNDi Scientific Advisory Committee and selected by the DNDi Executive Board, the 2024 awards recognize two projects from among more than 40 in DNDi’s R&D portfolio.
Partners and staff collaborating on the 2024 Projects of the Year were celebrated during a dedicated session of the 43rd meeting of the DNDi Scientific Advisory Committee on 4 October.
‘By identifying a promising new compound to bolster the research and development pipeline for visceral leishmaniasis and delivering an all-new, all-oral treatment for the most acute and lethal form of sleeping sickness, our 2024 projects of the year highlight the enormous power of partnerships to bring the best science for the most neglected,’ said Dr Laurent Fraisse, Director of R&D, DNDi. ‘These successful collaborations prove that by working together, we can advance scientific discovery and deliver life-saving medical innovations that change lives and contribute to the elimination of devastating diseases.’
2024 Project of the Year in pre-clinical research: DNDI-6899 – A boost to the drug discovery pipeline offering new hope for leishmaniasis
Last year, Bangladesh became the first country ever to receive official validation from WHO for eliminating visceral leishmaniasis as a public health problem. Other countries hit hard by the disease in South Asia and Eastern Africa are also making steady strides toward elimination – thanks in part to two decades of DNDi research that has helped bring safer, simpler treatments into use. Today, our focus is on delivering all-new, all-oral treatments that are still needed to achieve and sustain elimination of the disease wherever it occurs.
DNDI-6899 was nominated as a clinical candidate for leishmaniasis following successful pre-clinical development in collaboration with GSK Global Health Unit and the University of Dundee. After completion of a Phase I single-ascending dose study by GSK, further development was stopped by GSK in 2021, with rights to further develop the compound transferred to DNDi.
Recent work conducted by DNDi and partners at the University of Dundee and University of Antwerp revealed DNDI-6899’s unique mode of action, enabling the resumption of the clinical development programme. After presenting new scientific evidence to the UK health authorities in 2023 and receiving favourable feedback, preparations for a Phase I multiple-ascending dose study of DNDI-6899 are underway. The promising compound is now among the front-running candidates in DNDi’s leishmaniasis portfolio.
We are grateful to our many partners who have advanced this critical early work toward discovering and developing all-new treatments for leishmaniasis, including GSK Global Health Unit, the Drug Discovery Unit at the University of Dundee, and WuXi AppTech. We would also like to thank current partners involved in preparing for the next Phase I study – the University of Liverpool and Liverpool University Hospitals NHS Foundation Trust.
Visceral leishmaniasis – also known as kala-azar – is the second deadliest parasitic disease after malaria and causes fever, weight loss, spleen and liver enlargement, and, if not treated, death. Safer, simpler treatments are urgently needed – especially for children, who comprise up to 70% of cases in Eastern Africa. Continued innovation is critical to sustaining elimination in South Asia and achieving elimination targets in Eastern Africa.
2024 Project of the Year in clinical research: Fexinidazole for T.b. rhodesiense – A leap forward in the treatment of the most lethal form of sleeping sickness
Following completion of the FEXI007 trial and submission of a dossier to the European Medicines Agency (EMA) to extend fexinidazole’s indication for use against T.b. rhodesiense sleeping sickness, a favourable opinion from the EMA in December 2023 paved the way for the drug to be distributed to African countries where the most acute and lethal form of the disease is prevalent. In 2024, the World Health Organization changed its treatment guidelines to recommend fexinidazole as first-line treatment for the disease.
DNDi joined with partners to form the HAT-r-ACC consortium in 2018 to generate the clinical data needed to assess fexinidazole as a treatment for both stages of T.b. rhodesiense sleeping sickness. Started in 2019 in Malawi and Uganda, the FEXI007 clinical trial tested the safety and efficacy of fexinidazole in treating both stages of this form of the disease.
Together with project partners including our research allies in Uganda and Malawi and our pharmaceutical partner Sanofi, our teams are proud to have delivered the innovation needed to transform the treatment paradigm for people affected by sleeping sickness – moving us one important step closer to controlling and sustainably eliminating the deadly disease.
We are grateful to our many partners for making this remarkable achievement possible, including the Ministry of Health Malawi; Uganda National Health Research Organization (UNHRO); Rumphi Hospital, Malawi; Lwala Hospital, Uganda; Makerere University; NOVA University Lisbon, Institute of Hygiene and Tropical Medicine (IHMT/NOVA); Institut de Recherche pour le Développement (IRD); Epicentre (MSF); Swiss Tropical and Public Health Institute (Swiss TPH); and the World Health Organization (WHO).
Sleeping sickness – or human African trypanosomiasis (HAT) – is caused by a parasite spread by the bite of the tsetse fly. It can result in severe neuropsychiatric symptoms and is almost always fatal if left untreated. Until 2008, the most widely available treatment for advanced sleeping sickness was melarsoprol, an arsenic derivative so toxic it killed 1 in 20 patients. In 2018, DNDi, Sanofi, and partners delivered fexinidazole, a paradigm-changing all-oral treatment for both stages of T.b. gambiense sleeping sickness. In a further success for DNDi and partners, the treatment’s indication has now been expanded to include the less common but more acute form of the disease caused by T.b. rhodesiense.
Learn more about fexinidazole for T.b. rhodesiense
Watch a short film about the project from our industrial partner, Sanofi:
