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 2023 includes:

Development

Acoziborole: The recruitment and four-month follow-up of adult patients with non-parasitologically confirmed human African trypanosomiasis caused by T.b. gambiense were both completed, with 1208 participants treated with acoziborole. Data cleaning has been initiated and study results are expected in the first quarter of 2024. In parallel, nine children weighing between 30 kg and 40 kg and treated with 640 mg of acoziborole completed the 12-month follow-up visit. The study will resume in 2024 with the recruitment of children weighing 10 kg to 40 kg.

Implementation

Fexinidazole for T.b. gambiense: Access activities were consolidated in 2023 following completion of the clinical development of fexinidazole for T.b. gambiense sleeping sickness in 2022. All endemic countries are utilizing fexinidazole as a first-line treatment, health staff have been trained on the new treatment guidelines, and pharmacovigilance is ongoing in five countries (Democratic Republic of the Congo, Central African Republic, Guinea, Angola, and South Sudan). Community awareness activities were carried out in the most endemic areas of the Democratic Republic of the Congo using communication materials updated based on recommendations emerging from an ethnographic study implemented by DNDi and partners.

Fexinidazole for T.b. rhodesiense: In the first half of the year, the clinical study report was completed and a full dossier to extend the indication was provided to the European Medicines Agency (EMA). On 14 December, the EMA adopted a positive opinion of fexinidazole for the treatment of T.b. rhodesiense sleeping sickness, paving the way to launch access activities in 2024, beginning with support for registration of the new treatment by endemic country health authorities, training of health staff on new treatment guidelines, and informing affected communities about the new treatment’s availability. Pharmacovigilance activities for fexinidazole will be initiated as the treatment becomes available.

Photo credit: Lameck Ododo-DNDi