In April 2017, DNDi and GSK entered into an agreement for the pre-clinical development of two compounds  for leishmaniasis: GSK245 (formerly GSK245/DDD1305143) and DNDi-6899 (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 GSK245 (DDD1305143).

Project updates

2023

The development of GSK245 continues and GSK is the sponsor of a Phase I clinical study in healthy volunteers in the UK. The single ascending dose part of the study has been completed. This drug candidate shares a similar mode of action with LXE408, the frontrunner in DNDi’s portfolio of NCEs under development for leishmaniasis.

2022

GSK put the Phase I single ascending dose trial of GSK245 (DDD1305143) on hold in 2022 to perform additional investigations into the compound’s complex pharmacokinetics. The Phase I study of the compound is expected to resume and complete in early 2023. 

2021

A Phase I combined single ascending dose and multiple ascending dose study of GSK3494245/DDD1305143 in healthy volunteers began in late 2020 and continued in 2021, but faced delays due to the COVID-19 pandemic. It is now expected to be completed by mid-2022. 

2020

A Phase I single ascending dose study of GSK3494245/DDD1305143 in healthy volunteers began in late 2020 and is expected to be completed by Q3 2021. 

2019

A Phase I single ascending dose study of GSK3494245/DDD1305143 is planned to start in late 2020. 

2018

GSK3494245/DDD1305143 is currently under review to assess the feasibility of proceeding to a Phase I study.