Human African Trypanosomiasis Development

 

  • Target disease: HAT
  • Main partners (since project start): Sanofi, France; Swiss Tropical and Public Health Institute, Switzerland; Institute of Tropical Medicine Antwerp, Belgium; Médecins Sans Frontières; Institut de Recherche pour le Développement, France; Institut National de Recherche Biomédicale, DRC; HAT Platform; National Control Programmes of the Democratic Republic of Congo and the Central African Republic.
  • Project start: April 2007
  • Funding (since project start): Bill & Melinda Gates Foundation, USA; Department for International Development (DFID), UK; Dutch Ministry of Foreign Affairs (DGIS), the Netherlands; French government AFD, France; GIZ on behalf of the Government of the Federal Republic of Germany, Germany; Ministry of Foreign and European Affairs (MAEE), France; Médecins Sans Frontières/Doctors without Borders, International; Norwegian Government, Norway; Republic and Canton of Geneva, International Solidarity Office, Switzerland; Spanish Agency for International Development Cooperation (AECID), Spain; Swiss Agency for Development and Cooperation (SDC), Switzerland; Other private foundations and individuals.

 

Overall Objective:

  • Develop and register fexinidazole as a new oral drug for the treatment of stage 2 HAT caused by T. b. gambiense, ideally also for stage 1 HAT and for children between 6 and 14 years old.

 

 

Fexinidazole, the result of successful compound-mining efforts pursued by DNDi in 2005, entered clinical development in September 2009 and is being co-developed with Sanofi: DNDi is undertaking clinical and pharmaceutical development whilst Sanofi is responsible for the industrial development and production. Fexinidazole is the most advanced oral candidate under development for HAT. DNDi aims to evaluate and register it as a treatment for a wide range of patients, specifically in adults and children over 6 years of age and 20kg body weight with either stage of disease. A 10-day oral-only treatment, fexinidazole, if successful, will be able to be administered at the primary healthcare level, ideally allowing patients to take their treatments at home.

Two additional complementary cohorts with fexinidazole were completed in 2016, one including 230 adult patients with stage 1 and early stage 2 of the disease, and another including 125 children between 6 and 14 years, both in DRC sites. Follow up of patients will be completed in 2017.

A Phase IIIb aiming at getting more information about special population groups not included in previous fexinidazole trials (including pregnant or lactating women, and patients with poor nutritional status or with chronic diseases) started in 2016. Patients will be treated either in hospital, or at home, thereby providing also preliminary information about the treatment compliance and final effectiveness in ambulatory patients. Three sites were initiated (Bandudu, Mushie and Bagata) and six patients (out of a target of 174) had been recruited by the end of 2016.

The pivotal Phase II/III study with fexinidazole completed this year, the recruitment of 394 stage 2 HAT patients at ten clinical sites in the Democratic Republic of Congo and the Central African Republic. A second study in adult patients with stage 1 and early stage 2 of the disease that was initiated in 2014 has recruited 228 patients to date. A third study in children between six and 14 years, also initiated in 2014, has recruited 125 patients to date.


Last update: February 2017