Follow DNDi on LinkedInFollow DNDi on TwitterFollow DNDi on Facebook


Human African Trypanosomiasis Translation

  • Target disease: HAT
  • Partners (since project start): Anacor Pharmaceuticals Inc., USA; SCYNEXIS Inc., USA; Penn Pharma, UK; BaseCon, Denmark; Optimed, France; PhinC Development, France; Cardiabase, France; SGS Cephac, France; Patheon, UK; Accelera S.r.l., Italy
  • 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.

Overall Objective:
  • Develop and register SCYX-7158 as a new drug for the treatment of stage 2 HAT caused by T. b. gambiense, ideally also for stage 1 HAT

The oxaborole SCYX-7158, originally provided by Anacor Pharmaceuticals, was found to be active against T. brucei at the University of California San Francisco; was further investigated by a consortium consisting of DNDi, Anacor, SCYNEXIS, Pace University, and Swiss TPH; and was selected as a promising pre-clinical candidate for HAT in late 2009. In pre-clinical studies, SCYX-7158 was shown to be safe and efficacious in treating stage 2 of the disease, as it is able to cross the bloodbrain barrier. A tablet formulation demonstrated comparable pharmacokinetics to capsules used in a Phase I study and is therefore suitable for further clinical studies.

A reproductive toxicity package was completed in 2014, showing that the drug did not induce any abnormalities. In March 2012, SCYX-7158 became DNDi’s first new chemical entity resulting from lead optimization efforts to enter clinical development. Due to the longer than expected half-life in humans, additional animal studies were performed, which supported continued testing with single ascending doses of treatments in healthy volunteers. Safety profiling above the expected therapeutic dose was completed in 2015 with no identified cause for concern. Recruitment for a patient trial will begin in the DRC in 2016.

Last update: October 2015

Tags: HAT – Sleeping Sickness
Except for images, films and trademarks which are subject to DNDi’s Terms of Use, content on this site
is licensed under a Creative Commons Attribution-NonCommercial-Share Alike 3.0 Switzerland License