Since 2005, the DNDi office in the Democratic Republic of Congo (DRC) has provided essential logistical and financial support for the nifurtimox-eflornithine clinical trial (NECT), the fexinidazole trials, and the HAT Platform.
Projects
Clinical trial platform
Research and access consortiums
DNDi Democratic Republic of Congo
Avenue Milambo, n°4
Quartier Socimat
Commune de la Gombe
Kinshasa
Democratic Republic of the Congo
Tel: +243 81 659 79 95
Highlights
2019
- R&D: Completed patient recruitment for two clinical studies for sleeping sickness, including one for new chemical entity acoziborole
- Access: Started fexinidazole access trainings with the National Sleeping Sickness Control Programme; the first patient to receive
fexinidazole outside of a trial was treated in early 2020 - Capacity strengthening: Coordinated all HAT Platform activities; prepared clinical trial sites for upcoming study of TylAMac for onchocerciasis
2018
- Saw the registration of fexinidazole in DRC, the first all-oral treatment for sleeping sickness, only 39 days after the drug received a positive scientific opinion from the European Medicines Agency.
- Supported an ongoing Phase IIIb study in DRC and Guinea to assess effectiveness of fexinidazole in adults and children with sleeping sickness at any stage, including a sub-group receiving treatment at home.
- Supported ongoing Phase II/III studies in nine clinical sites in DRC and one in Guinea to test acoziborole as a single-dose treatment in patients with stage 1 or 2 sleeping sickness.
- Hosted the Human African Trypanosomiasis Platform – EANETT Joint Scientific meeting in Uganda with 116 participants for presentations and discussions on diagnosis, treatment, and care, including novel strategies to increase case detection in the elimination phase of the disease.
2017
- Support completion of fexinidazole clinical studies in adults (stage 1 and 2) and children with sleeping sickness
- Start of Phase IIIb study in seven clinical sites in DR Congo to generate information on fexinidazole in special population groups in in- and out-patients
- Start of Phase II/III study in nine clinical sites in DR Congo to test acoziborole as a single-dose treatment in patients with stage 1 or 2 sleeping sickness
2016
- Top-line results from the fexinidazole Phase III/IV study enable DNDi and Sanofi to pursue plans to submit for regulatory approval with the EMA in 2017.
- Phase II/III study starts in seven sites in DRC to test SCYX-7158 as a single-dose treatment in 350 patients with stage 2 HAT.
