DNDi’s screening of Anacor’s library of drug compounds from the oxaborole class, followed by focused medicinal chemistry efforts, led to the discovery of a number of analogues showing efficacy in animal models of sleeping
sickness, Chagas, and leishmaniasis.

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.

Project updates

2019

The clinical trial application for this study was approved in November 2019 and the first volunteer was enrolled in a Phase I single ascending dose study in January 2020. Pending study results, a multiple ascending dose study will start in late 2020. 

2018

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.

2017

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.

2016

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.