DNDI-6148

Activities related to the clinical development of DNDI-6148 remained on hold.

The development of DNDI-6148 for leishmaniasis has been deprioritized due to pre-clinical reproductive toxicity signals that could necessitate the use of contraceptives for women of childbearing potential.

The last cohort of the Phase I study was completed in the first quarter of 2022. DNDI-6148 was shown to be safe and well tolerated after a single oral dose. Preparation for the Phase I multiple ascending dose study in India was initiated in parallel with additional reproductive toxicology investigations.

Important data on reproductive toxicity have been generated and tablet formulation development activities have commenced. The Phase I single ascending dose study made significant progress in 2021 and will be completed in the first quarter of 2022. Preliminary results support the progression of DNDI-6148 to a multiple ascending dose study, which will be initiated in 2022. 

A Phase I single ascending dose study continued through 2020 but faced delays due to the COVID-19 pandemic. Study completion is expected in Q4 2021, and a multiple ascending dose study will follow in 2022.

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.

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 visceral leishmaniasis. 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.