Progress development of compounds for leishmaniasis
current phase of drug development
updated 1 Mar 2023
In April 2017, DNDi and GSK entered into an agreement for the pre-clinical development of two compounds for leishmaniasis that 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 licence agreement for GSK3494245/3186899.
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.
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