DNDi and our partners are working to deliver breakthrough treatments and expedite access to eliminate sleeping sickness – for good. Our current goal is to finalize the development of acoziborole, an all-new, single-dose oral drug that can be given at the point of care, opening the possibility of simplified ‘test-and-treat’ approaches in primary healthcare settings. At the same time, we are continuing work to ensure broad access to fexinidazole for sleeping sickness caused by the parasites T.b. gambiense and T.b. rhodesiense, the more acute, less common form of the disease.
Our progress in 2024 includes:
Development
Acoziborole: The results of the safety study conducted with 1,208 non-parasitological-confirmed seropositive participants confirmed the favourable safety profile of acoziborole for the treatment of T.b.gambiense sleeping sickness. The recruitment of seropositive participants in StrogHAT – an intervention study to evaluate acoziborole’s safety, effectiveness, and feasibility – started in northern Equateur province in the Democratic Republic of the Congo. The recruitment of children with T.b.gambiense sleeping sickness aged between 1 and 14 years old also began in the second step of the ACOZI-KIDS study.
Acoziborole for children (ACOZI-KIDS): DNDi and partners successfully initiated step 2 of the study, which includes children weighing between 10 and 40 kilograms and aged between 1 and 14 years old. A total of 27 patients – 9 in step 1 and 18 in step 2 – were included in the trial as of December 2024. Targeted community awareness activities for implementation in early 2025 were designed to support study site recruitment to reach a global target inclusion of 35 participants.
Implementation
Fexinidazole for T.b. gambiense: DNDi facilitated data collection for the post-approval safety study in Guinea and the Democratic Republic of the Congo (DRC). The study was sponsored by Sanofi, implemented by the national sleeping sickness control programmes, and managed by WHO. National pharmacovigilance teams from the DRC, Central African Republic, Guinea, Angola, and South Sudan underwent a DNDi-supported three-day training at the Morocco pharmacovigilance centre to consolidate links between the teams and enable horizontal support by the DRC national pharmacovigilance centre. DNDi also supported a six-week distance training for eight participants from the five countries. Access activities related to fexinidazole for T.b. gambiense sleeping sickness were completed at the end of 2024.
A scientific article on the last clinical trial on fexinidazole for T.b. gambiense – notably including pregnant and breastfeeding women and a sub-group treated at home – will be published in The Lancet Global Health in April 2025.
Fexinidazole for T.b. rhodesiense: In June 2024, WHO updated its treatment guidelines to recommend fexinidazole as the first-line treatment for T.b. rhodesiense sleeping sickness. In the same month, the Democratic Republic of Congo registered fexinidazole for the treatment of T.b. rhodesiense sleeping sickness. Malawi granted approval for use of the drug at the end of 2024. Health professionals in other countries where T.b. rhodesiense is endemic are being trained on sleeping sickness diagnosis and the new treatment guidelines by WHO, DNDi, and national control programmes (SSNCP). It is expected that treatment with fexinidazole will expand commensurately in 2025. Pharmacovigilance activities for fexinidazole will be initiated by WHO, DNDi, and national control programmes in step with rollout of the new treatment. A scientific article from the study is expected to be published in The Lancet Global Health in April 2025.
Photo credit: Brent Stirton/Getty Images
