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UNITE4TB/PAN-TB Joint Satellite Session at the 2023 Union Conference
Rethinking clinical trial design to accelerate improved treatment options for TB-affected communities: Innovative collaborations redefining TB drug and regimen development.
Tuberculosis (TB) remains a major global health challenge, necessitating continuous efforts to develop novel and effective treatments that can positively contribute to the global TB response. In this pursuit, UNITE4TB and PAN-TB have emerged as innovative partnerships that aim to accelerate the development of new TB drugs and regimens. These two collaborations bring together academic institutions, small and medium-sized enterprises (SMEs), public organizations, and pharmaceutical companies to address the unmet medical needs in TB care.
The 2023 Union World Conference on Lung Health took place in Paris, France, from 14 to 18 November – an excellent platform to showcase the progress and outcomes of both of these endeavors. The joint satellite session “Rethinking clinical trial design to accelerate improved treatment options for TB-affected communities: Innovative collaborations redefining TB drug and regimen development” provided a comprehensive overview of the ongoing efforts in TB drug development, focusing on the important work of the two partnerships. Speakers from both initiatives shared their insights and progress on various Phase 2b/c clinical trials aimed at creating novel regimens with improved safety and efficacy profiles that will expedite the development of new TB treatments.
The event took a deep dive into the clinical trial programs coordinated by each project and the collaboration between their respective teams. Trial design, as well as recently achieved and upcoming milestones were discussed.
Session Chairs Dr. Charles Wells, Head of Therapeutics Development at Bill & Melinda Gates Medical Research Institute, and Professor Michael Hoelscher UNITE4TB's Scientific Lead from the Division of Infectious Diseases and Tropical Medicine at LMU University Hospital Munich, welcomed participants. In their introduction, they emphasized the impact of TB from the perspective of communities affected by the disease.
Dr. David Holtzman, Clinical Development Leader, Bill & Melinda Gates Medical Research Institute, provided an Overview of the PAN-TB Collaboration Phase 2b/c TB Treatment Shortening Trial. The presentation reviewed key PAN-TB Phase 2b/c trial design features and operational considerations for trial execution. The PAN-TB Collaboration Phase 2b/c Treatment Shortening Trial incorporates treatment duration randomization, an approach used in other therapeutic areas but newer to TB, to down-select the investigational regimen and treatment duration with best performance characteristics for achieving success in a subsequent Phase 3 pivotal trial.
In his presentation on PAN-TB Phase 2b/c De-risking Trial Design, Dr. Ramesh Dass, Head of Commercial and Clinical Development Tuberculosis, Otsuka Pharmaceutical Companies (U.S), provided an overview and update on the PAN-TB Collaboration's approach to de-risking trial design for Phase 2b/c studies from the perspective of the Joint Development Team.
Dr. Hanif Esmail, Clinical Associate Professor in Infectious Diseases, University College London, spoke about UNITE4TB-01: A New PARADIGM of Evaluating Novel Drugs, giving insight into the UNITE4TB-01/PARADIGM4TB trial, a multi-arm multi-stage, Phase 2b/c, platform trial, to be conducted in 13 countries on four continents evaluating regimens containing GSK3036656 or BTZ-043 (novel drugs with first in class mechanisms of action) in adults with pulmonary TB. The first (2b) stage will evaluate multiple regimens for efficacy and safety. The most promising will move forward to the second (2c) stage, evaluating multiple durations of these regimens. The aim is to identify safe, effective regimens of short duration, which could treat both rifampicin susceptible and resistant TB, for future Phase 3 trials.
In her presentation, UNITE4TB: A DECISION on The Right Dose of BTZ-043, Dr. Wandini Lutchmun, Clinical Trial Physician, LMU University Hospital Munich, provided an update on BTZ-043, a novel benzothiazinone and DprE1 inhibitor, which has so far been clinically evaluated in Phase 1a, human ADME, and a Phase 1b/2a trial. It is one of the novel chemical entities being evaluated in the PARADIGM4TB platform trial. BTZ-043 DECISION is a Phase 2b, dose-ranging trial, evaluating the safety, tolerability, PK, and exposure-response relationship of BTZ-043 administered over 16 weeks in combination with Bedaquiline and Delamanid, in adults with drug-sensitive TB.
The presentation Beyond Clinical Trials: Empowering TB Communities for Accessible and Impactful TB Care, by Blessina Kumar, CEO of Global Coalition of TB Advocates and a Community Advisory Group (CAG) Member of UNITE4TB, delved into the question of why it is critical to listen to and consider the views of TB-affected communities at each stage of TB research. In her presentation, Blessina emphasized the importance of involving TB-affected individuals in research and clinical trials to foster a people-centered, rights-based response to TB. The work of both the Global Coalition of TB Advocates and the UNITE4TB CAG were provided as examples of how to advocate for community-centered approaches, amplify community voices on global platforms, and build collaborative partnerships for a more inclusive and successful global TB response.
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