Recipient organisationDrugs for Neglected Diseases Initiative
Funding£9.1M
PeriodNov 2024 — Oct 2027
In plain English
AI plain-English summary
Visceral leishmaniasis kills between 50,000 and 90,000 people each year, half of them children, and the drugs used to treat it are toxic and must be injected. The disease, spread by sandflies, hits the poorest communities hardest and is becoming more common as climate change shifts where the insects can survive. Current treatments were never designed for this parasite—they were borrowed from other diseases and come with severe side effects. Two new drug candidates, LXE408 and DNDI-6899, are now moving through clinical trials. LXE408, a proteasome inhibitor, has already shown positive results in India and is recruiting patients in Ethiopia. DNDI-6899, which blocks a different parasite enzyme, is in Phase 1. Both are taken orally, which means patients could be treated at local health centres instead of travelling to hospitals. If these drugs succeed, they would replace the painful, dangerous injections now standard in East Africa. The three-year project aims to have both candidates ready for Phase 2/3 trials in the region by mid-2027.
View original technical description
Visceral leishmaniasis (VL) affects some of the poorest people on Earth. Prone to outbreaks and fuelled by environmental and climate changes, WHO estimates 50,000 to 90,000 cases per year, 50% are children. VL is fatal if untreated. The drugs currently available to treat VL have been repurposed for this indication and have severe limitations, such as toxicity and parenteral routes of administration. In 2018, DNDi gathered the drug candidates for VL from different groups and, together with partners, progressed a portfolio of compounds along the R&D pathway. Today, LXE408, a kinetoplastid proteasome inhibitor, is the most advanced of these candidates, progressing in Phase 2 development in India (positive interim analysis in April 2024) and Ethiopia (first patient recruited in April 2024). DNDI-6899, a Leishmania CRK12 inhibitor, is the next most promising drug candidate, currently in Phase 1 development. These drug candidates have the potential to bring true innovation to patients: an oral, safe and efficacious treatment delivered at primary health care centres, close to communities, especially in Africa where a treatment combination is expected to be required. The three-year project will enable the progress of LXE408 and DNDI-6899 to prepare for Phase 2/3 in East Africa by mid-2027.
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