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ACADEMIA AND INDUSTRY UNITED INNOVATION AND TREATMENT FOR TUBERCULOSIS

Project description

DEENESFRITPL

New clinical trial design for tuberculosis drugs

As with many bacterial diseases, tuberculosis has been hit by drug resistance, threatening the efficacy of existing treatments. Although there are new drugs for clinical evaluation, testing the different combinations is time-consuming and requires a concerted effort. The EU-funded UNITE4TB project brings together experts in the field to design and set new standards for tuberculosis Phase II clinical trials. The team will take advantage of existing networks across continents to recruit patients in trials and introduce state-of-the-art microbiology methods and machine learning technologies. Data on biomarkers and clinical pharmacology will accompany the validation of the new drugs to ensure their subsequent success down the drug discovery pipeline.

Objective

Current 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 2B/C 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 intelligence/machine 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 2B/C. 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.

Fields of science

Programme(s)

Topic(s)

Call for proposal

H2020-JTI-IMI2-2020-20-two-stage

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Funding Scheme

RIA - Research and Innovation action

Coordinator

STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUM
Net EU contribution
€ 64 968 756,75
Address
Geert grooteplein 10 zuid
6525 GA Nijmegen
Netherlands

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Region
Oost-Nederland Gelderland Arnhem/Nijmegen
Activity type
Higher or Secondary Education Establishments
Links
Other funding
€ 0,00

Participants (31)

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EC signature date 29 June 2021
Last update: 31 December 2022

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Permalink: https://cordis.europa.eu/project/id/101007873

European Union, 2023