GSK3186899/DDD853651 & GSK3494245/DDD1305143

DNDi conducted a thorough evaluation of the opportunity to further develop GSK3186899/DDD853651 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.

GSK put the Phase I single ascending dose trial of GSK3494245/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.

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. 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.  

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. A Phase I multiple ascending dose study of GSK3186899/DDD853651 in healthy volunteers is planned, pending funding and Global Safety Board approval.

A Phase I single ascending dose study of GSK3186899/DDD853651 in healthy volunteers was completed in 2019; a Phase I single ascending dose study of GSK3494245/DDD1305143 is planned to start in late 2020.

GSK3186899/DDD853651 was nominated as a clinical candidate in 2018. GSK3494245/DDD1305143 is currently under review to assess the feasibility of proceeding to a Phase I study.