- Target disease: VL
- Main partners (since project start): Accelera, Italy; Advinus Therapeutics Ltd, India; Aptuit, Italy; London School of Hygiene & Tropical Medicine, UK; TB Alliance, USA; Auckland University, New Zealand; Laboratory of Microbiology, Parasitology and Hygiene, University of Antwerp, Belgium; Penn Pharmaceuticals Services, UK; Syngene, India; WuXi AppTech, China.
- Project start: September 2015
- 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); Médecins Sans Frontières/Doctors without Borders.
Following the termination of the VL-2098 project in early 2015, two lead compounds from the nitroimidazooxazine back-up programme were progressed. One of these, DNDI-0690, showed good to excellent activity in vitro against both VL and CL causing strains of Leishmania and was nominated as a preclinical candidate in September 2015.
DNDI-0690 and other potential lead compounds for VL were profiled in vitro against CL-causing strains of Leishmania at the London School of Hygiene & Tropical Medicine and the Walter Reed Army Institute of Research.
A full preclinical toxicology and safety studies package was completed in 2017. The decision to progress to Phase I Single Ascending Dose in healthy volunteers was agreed in January 2018.
In 2016, DNDi activities focused on pharmaceutical development activities (drug substance and drug product development and manufacture), launching of toxicity/safety pre-IND package with dose range finding studies, as well as refinement of ADME, 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: March 2018