- Target disease: HAT
- 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. Acoziborole is expected to be administered directly at home.
In 2018, recruitment of patients continued with 191 patients enrolled to date, including 148 late stage-2 patients. Three new clinical sites in Democratic Republic of Congo (DRC) – Nkara, Kimpese, and Bagata – were added to the already active sites (Katanda, Isangi, Roi Baudouin Hospital in Kinshasa, Dipumba, N’gandajika, Masi Manimba, Kwamouth, Bandundu). A new site also 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: February 2019