DNDI-6174

In 2022, Eisai Co., Ltd manufactured three batches DNDI-6174, with 2.9 kg allocated for regulatory pre-clinical studies, 3 kg for drug product development, and 5.7 kg for future clinical trials. After developing and evaluating different formulations, prototypes of 5 and 50 mg tablets were created for stability testing. In parallel, all necessary pre-clinical studies to support a Phase I clinical trial application were completed and their results will be used to determine whether Phase I clinical trials should proceed. Additionally, an in vivo study completed in 2022 confirmed DNDI-6174’s potential in treating cutaneous leishmaniasis.

2021 saw progress made on the drug substance with the selection of an HBr salt that showed very good solubility, scalability, and manufacturability properties. Moreover, the former synthetic route has been optimized and a reproducible process has been established, increasing throughput and reducing cost of goods. Pre-clinical activities have started with the selection of CRO partner Aptuit, an Evotec Company, and the development of the non-clinical formulation. 

Further characterization of DNDI-6174 and preparations to initiate pre-clinical activities continued in 2020. With support from Japan’s Global Health Innovative Technology Fund (GHIT Fund), DNDi and Eisai will start collaborating in Q2 2021 to conduct pre-clinical development activities and prepare the way for future Phase I clinical studies in healthy human volunteers. 

Planning is underway to start pre-clinical activities in 2020.