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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.

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.

With the project entering its final year, the last patient in the clinical trial completed their last visit on 12 October 2022. The trial team began preparing an initial study report before the study was completed to accelerate preparation of the full dossier to be submitted to the European Medicines Agency (EMA) by DNDi industrial partner Sanofi for their opinion on extending the indication of fexinidazole to include treatment for sleeping sickness caused by T.b. rhodesiense. The first scientific article on the ethnographic studies was submitted in December 2022; three additional articles are in preparation. Case detection, training, and communication activities continued throughout the year.

The Phase II/III study to evaluate the safety and efficacy of fexinidazole to treat T.b. rhodesiense sleeping sickness completed recruitment of all patients before the end of the year. The study will continue until the end of 2022 to allow for the follow-up of all patients for 12 months. Additional ethnographic studies were also conducted in Malawi and Uganda to explore the perceptions and practices of local communities and peripheral health centre staff regarding sleeping sickness, to inform interventions to improve rapid case detection and treatment. Posters and leaflets were developed within a large communication campaign to raise awareness of symptoms and the importance of rapid diagnosis and treatment.

DNDi’s Phase II/III study continued in Malawi. In Uganda, the protocol was approved in December 2019, but the study was put on hold due to the COVID-19 pandemic. Recruitment will begin in 2021.

To assess fexinidazole to treat HAT caused by T.b rhodesiense – the other, more virulent subspecies of the parasite affecting humans – a Phase II/III study that aims to enrol 34 stage two patients began with enrolment of the first patient in Malawi in October 2019. A total of 20 patients were enrolled by February 2020.

To provide clinical data to extend the indication to treat rhodesiense sleeping sickness with fexinidazole, we have joined with partners to form the HAT-r-ACC consortium with funding from the European & Developing Countries Clinical Trials Partnership. The consortium is working on a five-year project in Uganda and Malawi, which together account for 88% of rhodesiense sleeping sickness cases globally.