- Target disease: human African trypanosomiasis (sleeping sickness)
- Main partners (since project start): Advinus Therapeutics Ltd, India; Aesica, UK; Avista Pharma (formerly SCYNEXIS), USA; Cardiabase, France; Creapharm, France; Eurofins-Optimed, France; HAT Platform; Institute of Tropical Medicine, Antwerp, Belgium; Institut de Recherche pour le Développement, France; Institut National de Recherche Biomédicale, DRC; Luxembourg Institute of Health, Luxembourg; National Trypanosomiasis Control Programme, DRC; Patheon, UK; Pfizer Inc. (formerly Anacor Pharmaceuticals Inc.), USA; PhinC, France; RCTs, France; SGS, France; Swiss Tropical and Public Health Institute, Switzerland; Theradis Pharma, France.
- Project start: January 2010
- Funding (since project start): Bill & Melinda Gates Foundation, USA; Department for International Development (DFID), UK; Dutch Ministry of Foreign Affairs (DGIS), the Netherlands; Federal Ministry of Education and Research (BMBF through KfW), Germany; Médecins Sans Frontières/Doctors without Borders, International; Norwegian Government, Norway; Spanish Agency for International Development Cooperation (AECID), Spain; Swiss Agency for Development and Cooperation (SDC), Switzerland; BBVA Foundation, Spain; Other private foundations and individuals.
Acoziborole was selected as a pre-clinical candidate for g-HAT in late 2009. This resulted from DNDi’s own lead optimization project starting with an initial hit identified in the Anacor chemical library. In 2012, it became DNDi’s first new chemical entity resulting from its own lead optimization programme to enter clinical development.
The delivery of fexinidazole has improved therapeutic options for people with sleeping sickness. But the development of an additional, oral treatment, especially one that could be given as a one-day, one-dose treatment, could provide even better options, as well as supporting efforts to eliminate and sustain elimination of the disease.
In 2018, recruitment of patients continued with 189 patients enrolled by the end of the year, including 155 patients with late stage-2-disease, and the target enrolment of 210 patients reached by March 2019. Four new clinical sites in the Democratic Republic of Congo (DRC) were added to the already active sites (Katanda, Isangi, Roi Baudouin Hospital in Kinshasa, Dipumba, N’gandajika, Masi Manimba, Kwamouth, Bandundu) and a new site was opened in Guinea (Dubreka).
Recruitment continued in the DR Congo with the inclusion of 76 patients (out of a target of 210) at eight clinical sites, including new sites in Bandundu and Kinshasa (Roi Baudouin Hospital), in addition to Katanda, Isangi, Dipumba, N’gandajika, Masi Manimba, and Kwamouth. One site (Bolobo) was closed in December 2017. Three more sites will open in 2018, including one in Guinea. The submission of a regulatory dossier to the European Medicines Agency under Article 58 is planned for 2021.
A pivotal Phase II/III trial started in the last quarter of 2016. Seven study sites – Katanda, Isangi, Dipumba, Ngandajika, Masi Manimba, Kwamouth, and Bolobo – were initiated in Democratic Republic of Congo (DRC). Eleven patients (out of a target 350) had been recruited by the end of 2016.
Last update: August 2019