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Advancing TB Treatment: An Update on the PARADIGM4TB Trial
As we near the one-year mark since launching UNITE4TB’s Phase 2B/C clinical trial program, which currently includes the DECISION and PARADIGM4TB studies, we reflect on the progress made. In July, we completed participant recruitment for the DECISION study. So how is the PARADIGM4TB trial advancing? To find out, we spoke with Ilaria Motta, Principal Clinical Research Fellow at the Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL) – sponsors of the PARADIGM4TB trial.
Can you tell our readers about the PARADIGM4TB trial?
PARADIGM4TB is a platform trial that evaluates multiple TB treatment regimens and durations. It focuses on optimizing combinations of novel drugs with established therapies. Investigating several regimens and novel chemical entities simultaneously has not been done before. This innovative approach aims to significantly shorten the development time for new TB treatments.
What is the status of the PARADIGM4TB trial and what lies ahead in 2025?
Since enrolling its first participant in January 2024, PARADIGM4TB has recruited 100 participants1 across eight sites in three countries in Africa (South Africa, Tanzania, and Uganda). Trial activities will soon expand to Asia (Vietnam) and Europe (Moldova), with plans for further sites in Asia, Africa, and South America in 2025.
What challenges has PARADIGM4TB encountered and how were these overcome?
Developing new TB therapies often comes with significant scientific and operational challenges. The process of implementing complex trials like PARADIGM4TB is lengthy and requires extensive coordination and resources. Securing contracts, approvals, permits, and training at global, national, and site level takes many months. Each milestone is a little victory, achieved by teamwork with the sites. Constant communication among partners in the UNITE4TB Consortium has been crucial to our success, especially in accessing the novel compounds, insights, and networks of EFPIA2 representatives.
How does PARADIGM4TB contribute to advancing research in TB treatment?
PARADIGM4TB offers the possibility to investigate several regimens and novel chemical entities together. In this first wave, we are investigating 10 experimental regimens that include drugs like GSK-656 and BTZ-043 (from LMU University Hospital Munich). Additional drugs and combinations are planned to be added in 2025 in a second wave. The high degree of collaboration within the UNITE4TB Consortium and the innovative design of the PARADIGM4TB trial help shorten the usual time required to collect evidence on novel TB compounds with new mechanisms of action. We are hopeful that our work will lead to more effective treatments for those affected by this deadly but curable disease.
Watch this short clip of Ilaria explaining the PARADIGM4TB
Watch this video on the start of the UNITE4TB clinical trial program
View more UNITE4TB videos on our website and YouTube channel
Follow UNITE4TB on LinkedIn
1 As of 6 November 2024
2 European Federation of Pharmaceutical Industries and Associations