In April 2017, DNDi and GSK entered into an agreement for the pre-clinical development of two compounds for leishmaniasis: DNDi-6899 (formerly GSK899/DDD853651) and GSK245 (DDD1305143) (formerly GSK899/DDD853651). The compounds were developed through a collaboration between the GSK Global Health Unit and the Drug Discovery Unit at the University of Dundee, with co-funding support from Wellcome. In February 2020, DNDi and GSK signed a development and license agreement for DNDI-6899.
Project updates
2023
Following a positive meeting with health authorities in the UK in early 2023, DNDi restarted the development of DNDi-6899 and advanced preparations for a clinical Phase I multiple ascending dose study. The active pharmaceutical ingredient stored by GSK at WuXi AppTech was successfully reprocessed and formulated to support the initiation of a multiple ascending dose study in 2024.
2022
DNDi conducted a thorough evaluation of the opportunity to further develop DNDI-6899 in 2022 and is now prioritizing its development given the compound’s unique mode of action as demonstrated through additional data generated by the University of Dundee. A meeting with the relevant health authorities to discuss the next steps of clinical assessment is planned for early 2023.
2021
GSK stopped development efforts on GSK3186899/DDD853651 in September 2021, giving DNDi the option to continue further development of the compound – a decision about which will be made in 2022.
2020
A Phase I multiple ascending dose study of GSK3186899/DDD853651 in healthy volunteers is planned, pending funding and Global Safety Board approval.
2019
A Phase I single ascending dose study of GSK3186899/DDD853651 in healthy volunteers was completed in 2019.
2018
GSK3186899/DDD853651 was nominated as a clinical candidate in 2018.