DNDI-6899 (GSK899/DDD853651)

The clinical trial application for Phase I evaluation in healthy volunteers, including food effect and multiple ascending dose studies, was approved on 5 July 2024 by the Research Ethics Committee and the UK Medicines and Healthcare Products Regulatory Agency (MHRA). Further start-up activities progressed and funding for the trial was granted by Wellcome in November 2024.

Anticipated to start in early 2025, the Phase I study will be performed at the MHRA-accredited NHS Phase I unit at the Royal Liverpool University Hospital, UK, in partnership with the University of Liverpool and the Liverpool University Hospitals NHS Foundation Trust.

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.

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.

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 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. 

GSK3186899/DDD853651 was nominated as a clinical candidate in 2018.