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| • Target disease: HAT • Partners: SCYNEXIS Inc., USA; Anacor Pharmaceuticals Inc., USA; Advinus Therapeutics, India; Penn Pharma, UK • Management: Discovery and Pre-clinical Director: Robert Don; Head of Pharmaceutical Development, Stephen Robinson; Head of HAT Clinical Programme: Antoine Tarral; Clinical Manager: Séverine Blesson; Project Coordinator: Delphine Launay • Project start: January 20120 • Funding: 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; Spanish Agency for International Development Cooperation (AECID), Spain; Swiss Agency for Development and Cooperation (SDC), Switzerland |
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Objective: Progress the clinical development of SCYX-7158 for the treatment of stage 2 HAT caused by T.b. gambiense, as well as for stage 1 HAT and HAT caused by T.b. rhodesiense. SCYX-7158 belongs to a unique boron-based chemical class, the oxaboroles, which was originally provided by Anacor Pharmaceuticals and screened for activity against T. brucei at the University of California San Francisco. A unique collaboration between DNDi, Anacor Pharmaceuticals (a biopharmaceutical company in Palo Alto, California, USA) and SCYNEXIS (a drug discovery and development company based in Research Triangle Park, North Carolina, USA), within a consortium that also included Pace University (USA) and the Swiss TPH, enabled the identification of SCYX-7158, selected as a promising preclinical candidate in late 2009. In pre-clinical studies, SCYX-7158 was shown to be safe and efficacious to treat stage 2 of the disease, as it is able to cross the blood-brain barrier. Pre-clinical development progressed successfully through 2010, and all pre-clinical data were published in PLoS NTD in June 2011.(1) In 2011, regulatory toxicology studies were performed to assess the compound’s safety. Batches of drug substance and drug product were produced according to current good manufacturing practices (cGMP). Finally, the Investigational Medicinal Product Dossier (IMPD) and the study protocol were approved by the ethics committee and the French regulatory authority, AFSSAPS. Following their clearance, SCYX-7158 entered First-in-Human studies in early 2012 and became DNDi’s first entity resulting from lead optimization efforts to enter Phase I clinical studies. This study will assess its safety and tolerability in healthy adults in Paris, France. |
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Read DNDi's press release on the start of Phase I study. |
Last update: December 2012
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