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PanTB-HM Clinical Trial Begins Recruitment in South Africa

PanTB-HM Clinical Trial Begins Recruitment in South Africa

The panTB-HM clinical trial has begun patient recruitment in South Africa, with first patient dosed on 28 July 2023. This trial is a historic milestone in the quest to revolutionise tuberculosis (TB) treatment and improve outcomes for all TB patients.

The panTB-HM trial addresses the World Health Organisation (WHO) target profile for new TB regimens that can be administered without prior knowledge of rifampicin susceptibility, the marker for multi-drug resistant TB. The panTB-HM trial is designed as a phase 2c trial, aligning with WHO recommendations for TB regimen development.

The trial's primary objective is to assess the proportion of patients with durable, non-relapsing cure, representing a pivotal step in advancing TB treatment paradigms. The goal is a more effective, shorter-duration TB treatment that protects lung function during and after treatment.

The innovative regimen contains new TB drugs bedaquiline and pretomanid and the experimental new oxazolidinone sutezolid. Extensive preclinical studies and phase 1 and 2 clinical trials of sutezolid demonstrated excellent safety over up to three months of daily oral dosing, a substantially better safety profile than other oxazolidinones used in TB regimens (i.e., linezolid).

Even after successful treatment with standard drug regimens, many TB survivors endure persistent lung conditions, such as bronchiectasis and fibrosis, that gradually erode lung function. The panTB-HM trial incorporates N-acetylcysteine (NAC), a repurposed host-directed WHO essential medicine. NAC is used to protect both the liver and lung from oxidative damage, preserving lung function and accelerating the eradication of MTB infection by replenishing glutathione (GSH).

Tuberculosis remains a formidable global health challenge, causing significant morbidity, mortality, and socio-economic consequences. In 2021, WHO estimated 10.6 million cases of TB worldwide and >500,000 of these patients had multi-drug resistant TB. TB continues to be the global infectious disease with the highest mortality rate, with 1.6 million deaths in 2021, topped only by pandemic COVID.

The panTB-HM trial is a collaboration led by The Aurum Institute, with Prof Robert Wallis as Aurum Institute Chief Scientific Officer and Principal Investigator of the trial. The consortium includes academic institutions Ludwig-Maximilians-Universitaet Muenchen (Germany) Stellenbosch University (South Africa), and Stichting Katholieke Universiteit-Radboudumc (Netherlands); clinical trial sites include Wits Health Consortium`s Clinical HIV Research Unit (South Africa) and National Institute for Medical Research in Mbeya (Tanzania, United Republic of); the consortium also includes a corporate collaborator, Sequella Inc (United States).

The trial is funded by the European & Developing Countries Clinical Trials Partnership (EDCTP), grant number RIA2019AMR-264.

Clinical Trial Registration Information Sites:

Pan African Clinical Trials Registry: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=24206

South African Clinical Trials Registry: https://sanctr.samrc.ac.za/TrialDisplay.aspx?TrialID=6986



About The Aurum Institute

The Aurum Institute is a proudly African organisation working to advance health science and innovation to create a healthier world for future generations. We partner with governments, the private sector and civil society to design and deliver high-quality care and treatment to people in developing communities. https://www.auruminstitute.org/

For the latest information and updates on the panTB-HM trial, please visit our official website at https://pantb-hm.org/.

For media inquiries and additional details, please contact:

Don Mudzengi Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

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