Academia Industry United Tender

Grant agreement ID 101007873Start date 1 June 2021End date 31 May 2028Overall budget 185 000 000 ObjectiveCurrent anti-tuberculosis TB drug regimens face serious limitations at times of increasing antimicrobial drug resistance. Fortunately for the first time for centuries several novel anti-TB compounds are available for clinical evaluation. As the traditional approach to testing these in multiple combination regimens is too slow and inefficient new approaches of clinical phase 2 study designs are required if we are to meet the targets of the WHO EndTB strategy to save the lives of millions into the near future. Our consortium brings together a unique group of European and international leaders in TB research and leading industry partners. Together we will provide the necessary comprehensive range of expertise to meet the demands of the UNITE4TB scientific research agenda. Specifically we will develop a new global standard for phase 2 TB clinical trial designs utilising simulation tools to identify optimal doses in phase 2A trials and apply a multi-arm multi-stage adaptive randomised controlled 2BC trial design capable of rapid and simultaneous evaluation of the best candidate regimens. Our innovative phase 2 trials will be performed to the highest regulatory standards incorporating state-of-the-art microbiology biomarker investigation and clinical pharmacology. We will take advantage of existing global TB clinical trial networks with the capacity to enrol patients at an unprecedented pace and number across four continents. Artificial intelligencemachine learning technologies will be applied to validate state-of-the art molecular and imaging tools as treatment decision biomarkers with the aim of establishing new real-time outcome measures. Our consortium will evaluate 3-5 new chemical entities NCEs at phase 2A and up to 17 novel combination regimens in phase 2BC. Our objective is to identify those that have the greatest chance of success in subsequent definitive phase 3 clinical trials and of becoming the global gold-standard TB regimens of the future.