- Target disease: Leishmaniasis
- Main partners (since project start): Accelera, Italy; Avista Pharma (formerly SCYNEXIS Inc.), USA; Charles River (formerly Wil Research), France; Crystallise!, Switzerland; Eurofins-Optimed, France; Laboratory of Microbiology, Parasitology and Hygiene, University of Antwerp, Belgium; London School of Hygiene & Tropical Medicine, UK; Pfizer Ltd. (formerly Anacor Pharmaceuticals Inc.), UK; Sandexis, UK; Sara Pharm, Romania; Syngene, India; WuXi AppTech, China.
- Project start: January 2010
- Funding (since project start):Bill & Melinda Gates Foundation, USA; Department for International Development (DFID), UK; Médecins Sans Frontières/Doctors without Borders Switzerland; Special Programme for Research and Training in Tropical Diseases (WHO-TDR), Switzerland; Swiss Agency for Development and Cooperation (SDC), Switzerland.
DNDi and Anacor have been working together over the last few years to identify oxaborole compounds, initially for the HAT programme, and this has expanded to include both leishmaniasis and Chagas disease. DNDI-6148 has emerged as a promising lead candidate for visceral leishmaniasis and cutaneous leishmaniasis and by the end of 2015 studies including exploratory toxicology necessary for possible progression to preclinical development had been successfully completed.
The decision was made in 2018 to progress to a Phase I single ascending dose in healthy volunteers in parallel with additional toxicological investigations. A clinical trial application for a first-in-human study (Phase I) was submitted to the French authorities in October.
The pre-clinical toxicology package was completed in 2017, and the decision was made to progress to Phase I single ascending dose in healthy volunteers in parallel with additional toxicological investigations.
In January 2016, DNDI-6148, from the oxaborole class, was nominated as a pre-clinical candidate for the treatment of VL. Pharmaceutical development activities (drug substance and drug product development and manufacture) have now been initiated, and the toxicity/safety pre-IND package was launched starting with dose range finding studies, along with refinement of ADME (absorption, distribution, metabolism and elimination), efficacy and safety profile to ensure a smooth transition from the pre-clinical phase to Phase I clinical phase, which should happen over the course of 2017.
Last update: February 2019