Research shows two novel antibiotics could spare patients from severe side effects.

Johannesburg, 01.07.2025 – Two international clinical studies led by PD Dr Norbert Heinrich at the Institute of Infectious Diseases and Tropical Medicine at LMU University Hospital Munich with international partners have shown the safety and efficacy of two promising antibiotics as potential alternatives to linezolid in the treatment of tuberculosis.
The drugs, sutezolid and delpazolid, have demonstrated strong antimicrobial activity and a notably better safety profile compared to linezolid, with potential to replace this current cornerstone in the treatment of drug-resistant TB. The findings were published on 30 June in two peer-reviewed articles in The Lancet Infectious Diseases, one of the world’s leading journals in the field of infectious disease medicine. Research partners in Germany included the German Center for Infection Research (DZIF), Munich, the Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, the Center for International Health at LMU University Hospital and Helmholtz Munich.

The Challenge with Linezolid

In 2022, the World Health Organisation introduced linezolid as part of the BPaLM regimen, also comprising bedaquiline, pretomanid, and moxifloxacin, as the standard recommended 6-month treatment for patients with multidrug-resistant TB—reducing the duration from the previous standard 18 months. However, linezolid is problematic for patients as it shows significant toxicity. This prolonged exposure to linezolid, much longer than the originally intended use for bacterial skin infections, frequently leads to serious adverse events like anaemia or optical neuropathy, which are distressing for patients, may not resolve fully, and can require discontinuation of therapy, limiting treatment success.

“Despite its effectiveness, linezolid is simply too toxic for many patients. We urgently need safer alternatives in this antibiotic class,” says PD Dr Norbert Heinrich.

Both sutezolid and delpazolid are members of the oxazolidinone class, like linezolid, but are less toxic for patients. In two innovative Phase 2b clinical trials – SUDOCU (PanACEA Sutezolid Dose-finding and Combination Evaluation) and DECODE (PanACEA DElpazolid Dose-finding and COmbination DEvelopment) – both drugs were tested in combination with bedaquiline, delamanid, and moxifloxacin, making them the first trials to use these specific four-drug combinations. The studies, conducted in South Africa and Tanzania, showed that in patients with drug-sensitive pulmonary TB, both drugs are safer and more tolerable for patients than linezolid would be.

Key findings show better patient outcomes

Sutezolid was shown to be effective with strong antibacterial activity and was well tolerated across all tested doses, with no cases of nerve damage or blood toxicity—a critical advantage over linezolid. These results suggest sutezolid could be a safer alternative for future TB treatment regimens, particularly in long-term use, although no final dose recommendation can be made yet.

Delpazolid enhanced the effectiveness of the combination regimen with bedaquiline, delamanid, and moxifloxacin. A once-daily dose of 1200 mg achieved the desired drug levels for maximum efficacy and was well tolerated over 16 weeks. Importantly, no cases of nerve damage or blood-related side effects were observed at this dose. These results position delpazolid as a promising alternative to linezolid for future TB treatment regimens—pending confirmation in larger studies.

“These findings suggest that both drugs may offer safer treatment options for TB patients, particularly those requiring longer courses of therapy,” – noted Dr Tina Minja, National PI for the DECODE study at NIMR-Mbeya Medical Research Centre in Tanzania.

A Collaborative Global Effort

The studies were conducted as part of the PanACEA (Pan-African Consortium for the Evaluation of Anti-Tuberculosis Antibiotics) network, which includes clinical and academic partners across Africa and Europe. Both the SUDOCU and DECODE trials were innovative Phase 2b, open-label, randomized clinical studies that systematically compared different dosing levels to evaluate antibacterial activity, drug exposure, and safety profiles of sutezolid and delpazolid.

The Aurum Institute contributed through its Tembisa and Pretoria Clinical Research Sites in South Africa, where patient recruitment and pharmacokinetic sub-studies were conducted. Aurum’s involvement is part of its long-standing commitment to advancing TB treatment through clinical research.

Aurum is proud of its and collaborators’ key involvement in the trials testing sutezolid and delpazolid — new drugs known as oxazolidinones in the SUDOCU and DECODE trials. These drugs demonstrate improved tolerance over linezolid, currently used in the treatment of resistant TB, and offer significant potential for pan-TB regimens that target all strains of tuberculosis, regardless of rifampicin susceptibility. Whether they may also serve as improved alternatives to linezolid in treating Methicillin-resistant Staphylococcus aureus (MRSA) remains to be studied.

“I’m delighted to see the positive findings from these trials. Before coming to Aurum, I led Pfizer’s phase 1 and 2 studies of sutezolid. Aurum is currently conducting a phase 2c EDCTP-supported trial of three 4-month sutezolid-containing regimens for a pan-TB indication. This trial will be completed early next year.

I remain very optimistic that the promise of superior antimycobacterial activity and superior safety exhibited by sutezolid will be maintained. These new regimens have the potential to change the face of TB treatment,” said Dr Robert Wallis, former SUDOCU Principal Investigator and Chief Scientific Officer at The Aurum Institute.

Looking Ahead

The publication in The Lancet Infectious Diseases underscores the scientific relevance of these results and their potential to shape future TB treatment strategies. “Seeing fewer side effects with sutezolid and delpazolid is a significant step forward—it brings us closer to TB therapies that are both effective and easier for patients to tolerate”, commented Dr Ivan Norena, medical team lead at the Institute of Infectious Diseases and Tropical Medicine at LMU University Hospital Munich.
Further research is now planned to evaluate sutezolid and delpazolid in larger cohorts and in fully optimised treatment combinations. If the promising results are confirmed, these drugs could play a critical role in the next generation of TB therapies, helping to reduce treatment-related side effects while maintaining efficacy.

Funding Acknowledgment

The SUDOCU study was conducted by the PanACEA consortium, funded by the EDCTP2 programme supported by the European Union with assistance from the Federal Ministry of Research, Technology and Space (BMFTR), and Nederlandse Organisatie voor Wetenschappelijk Onderzoek (NWO). Further funding was provided by the German Center for Infection Research (DZIF); Otsuka provided delamanid for this study at no cost to the consortium; and Sequella provided sutezolid active pharmaceutical ingredient at no cost.

Additionally, DECODE was funded by LigaChem Biosciences; and utilised the PanACEA consortium structures that were established with support by the funders mentioned above. Otsuka provided delamanid tablets free of charge for this project.

Further Information

Delpazolid in combination with bedaquiline, delamanid, and moxifloxacin for pulmonary tuberculosis (PanACEA-DECODE-01): a prospective, randomised, open-label, phase 2b, dose-finding trial

Sutezolid in combination with bedaquiline, delamanid, and moxifloxacin for pulmonary tuberculosis (PanACEA-SUDOCU-01): a prospective, open-label, randomised, phase 2b dose-finding trial

The patient pursuit of safe treatment options for tuberculosis (The Lancet Comment by Rubeshan Perumala and Kogieleum Naidooa) 

Lancet Inf Dis Podcast with Lilian Tina Minja and Norbert Heinrich on TB drug development 

Press Release LMU Klinikum 

JOHANNESBURG, 27 November 2024. The BAMMISHO Node, or Bafokeng Health & Demographic Surveillance System (HDSS), has been officially launched as the latest South African Population Research Infrastructure Network (SAPRIN) site in the Royal Bafokeng Nation, North-West Province. Located near Rustenburg’s platinum mines, this research hub will focus on the social and health effects of mining and migration on local communities.

Dr. Kobus Herbst, SAPRIN Director, remarked, "The addition of BAMMISHO as our seventh node marks an important expansion of SAPRIN’s network. This new site will not only generate essential insights into the health and socio-economic impacts of mining and migration but also strengthen our collective research capacity to address the unique challenges facing South African communities.” Dr Kobus Herbst, SAPRIN director “welcomed BAMMISHO as the seventh and newest node in South Africa aiming to produce high-quality research and enhance research capacity."

Led by the AWISE collaboration—a partnership including Aurum Institute, Wits University, Sefako Makgatho University of Health Sciences, and Johns Hopkins University—the BAMMISHO Node is set to gather robust, long-term data on health, migration, and demographic patterns in the Bojanala District. Home-grown public health experts Professor Keitshepile Geoff Setswe and Professor Malla Mathildah Mokgatle, along with Professors Chris Hofman and Latifat Ibisomi, will guide this project, with Ms. Ireen Mosweu leading community engagement efforts.

"Our goal is to create a world-class research site that not only informs public health policies but also improves community health outcomes," said Prof. Setswe. The Node will serve as a platform for high-impact research, attracting international and local researchers while supporting Vision 2035 of the Royal Bafokeng Nation and the UN Sustainable Development Goal 3 on health and well-being.

Dr. Koketso Rakhudu, Kgosana of the Tsitsing village of the Royal Bafokeng Nation, welcomed the node. "This represents a significant step forward in our commitment to enhancing the health and well-being of our people, ensuring that the impact of mining and migration is thoroughly understood and addressed."

Key research activities include tracking 100,000 residents across 43,000 households to map demographic changes and health trends over time, addressing critical health challenges like HIV/AIDS, TB, chronic diseases, and the impacts of migration. The Node also aims to build a network of early-career researchers, offering financial support for smaller, community-based projects.

Dr Malebo Maponyane, Head of Health and Social Development Services at the Royal Bafokeng Nation said "The launch of the BAMMISHO Node is a pivotal moment for the Royal Bafokeng Nation. As the Head of Health and Social Development Services, I am committed to leveraging this research hub to enhance our understanding of mining and migration impacts. By prioritizing data-driven decisions, collaborating with esteemed partners, and engaging with our community, we will drive initiatives that ensure a healthier and more resilient future for all Bafokeng citizens." With three core units—implementation research and data management, clinical and laboratory research, and health systems research—the BAMMISHO Node will support studies that address urgent health and socio-economic needs while driving policy transformation for long-term community resilience.

"Through our work in the BAMMISHO Node, we aim to integrate behavioural and social research into our health initiatives, ensuring that we address the social determinants of health and improve access to services for all community members." shared Prof. Mokgatle, Head of the Department of Public Health at Sefako Makgatho University of Health Sciences

For more information, please contact Aurum Group Senior Marketing and Communications Director, Kanya Ndaki: This email address is being protected from spambots. You need JavaScript enabled to view it.(+27 832986100).

About SAPRIN

South African Population Research Infrastructure Network (SAPRIN) is a major new long-term investment in a national research infrastructure, funded by the national Department of Science, Technology, and Investment (DSTI) and hosted by the SA Medical Research Council (SAMRC). SAPRIN’s vision is equitable health and social wellbeing. Our mission is to achieve this through a dynamic and impactful research infrastructure underpinned by longitudinal population-based nodes in under-resourced communities across South Africa.

SAPRIN is a valuable resource for researchers and policymakers working to improve the health and wellbeing of South African communities. Through its focus on collaboration, partnership, and ethical research practices, SAPRIN is helping to build a more robust and responsive research infrastructure in South Africa, and to support evidence-based decision-making and policy development.

Of the seven SAPRIN nodes, four are rural and they are Agincourt (Mpumalanga), DIMAMO (Limpopo), AHRI (KwaZulu – Natal) and BAMMISHO (North – West). There are three urban nodes; GRT-INSPIRED (Gauteng), C-SHARP (Western Cape), and USINGA (KwaZulu-Natal). https://saprin.mrc.ac.za

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. www.auruminstitute.org

About Wits School of Public Health

This multi-disciplinary school produces skilled public health practitioners appropriately trained to address the range of public health needs and challenges within South African and African settings. www.wits.ac.za/publichealth

Sefako Makgatho Department of Public Health

Sefako Makgatho Health Sciences University (SMU), as the only health sciences university in South Africa, is strategically positioned to focus on multidisciplinary health research that will provide solutions to ease the quadruple burden of disease facing the country. www.smu.ac.za/public-health-programmes

The Royal Bafokeng Nation is a community in the North West Province of South Africa, primarily known for its rich cultural heritage and significant mineral wealth, particularly platinum. The Bafokeng people have a long history dating back to the 12th century, and they are led by a hereditary king, currently Kgosi Leruo Molotlegi.

This rural nation has successfully leveraged its mineral resources to invest in infrastructure, education, and economic development, making it one of the most prosperous rural communities in South Africa. The Royal Bafokeng Administration manages these resources and initiatives, aiming to create a sustainable and self-sufficient community. https://www.bafokenginstitute.org.za

About Johns Hopkins University

Johns Hopkins University, founded in 1876 as America’s first research university, is a global leader in education, research, and innovation. With a mission to advance knowledge and foster independent thinking, Johns Hopkins is home to world-renowned faculty, groundbreaking discoveries, and transformative scholarship across disciplines.

The university's commitment to excellence spans nine academic divisions, including the Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Medicine, and the Bloomberg School of Public Health. Johns Hopkins consistently ranks among the top universities globally, driven by its dedication to addressing complex challenges and improving lives worldwide. www.jhu.edu.

JOHANNESBURG, 26 August 2024. The Aurum Institute, a leading Africa-based global health organisation today announced that Professor Dave Clark will succeed Professor Gavin Churchyard as Group CEO, effective Jan. 1, 2025. Prof Churchyard, who founded Aurum and has led the organisation for 26 years, will retire at the end of 2024. Aurum is a leader in the prevention and treatment of HIV and tuberculosis (TB) and played an important role in Africa’s COVID response.

Prof Clark, who holds degrees in medicine (MBBCh), business administration (MBA), commerce (BCom) and health services management (DHSM), has been an integral part of Aurum's leadership since its founding. As the current Group chief operating officer, he brings comprehensive insight into the organisation's mission and operations and governance systems, all designed to generate evidence for policy and how it is translated into health care practice.

"I am honoured to lead Aurum into its next chapter," said Prof Clark. "Aurum's strength lies in our ability to be locally rooted and globally influential. We will build on this foundation to continuously improve global health, from our crucial work in TB and HIV to addressing the rise of non-communicable diseases, particularly in Africa, and strengthening global health security in advance of future pandemics."

Professor Clark has overseen the implementation of Aurum’s large body of work throughout Africa. He has played a pivotal leadership role in all of Aurum’s research and health programmes to date, most notably in the grants awarded under the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), the US Government’s premier programme to end the HIV epidemic. Aurum’s work under PEPFAR has seen over 850,000 lives saved through antiretroviral therapy over the past 20 years.

Referencing the impact of Aurum’s work, Prof Clark said, “It is incredible to see the health of an individual change because evidence has influenced policy at a national and global level. Aurum is uniquely positioned to drive such changes. We do the science and the clinical trials, use the evidence they generate to influence policy and then implement those policies in the trenches of global health delivery. And we do it with the most incredible staff and partners in the world.” 

Dr Jerry Gule, chair of Aurum's board of directors, enthusiastically endorsed the appointment. "Prof Clark's selection by the Board was unanimous. It came after a rigorous process that considered nearly 200 candidates. His deep understanding of Aurum, coupled with his vision for the future, makes him the ideal leader to build on Prof Churchyard's remarkable legacy. The Board is committed to supporting Prof Clark in maintaining Aurum's strong African identity while expanding its global influence," shared Dr Gule.

Previously, Prof Clark worked as a medical doctor and later became the general manager of Anglogold Health Services, providing health care for 300,000 gold miners acutely vulnerable to HIV and TB. He joined Aurum in 2004 as deputy CEO and executive director of the board to operate on the cutting edge of HIV and TB research. He has played a pivotal role in its growth from a small research foundation with a staff of 30 to a major global health organisation with a staff of 3,000. His operational and governance leadership has enabled the organisation to manage large-scale, complex health programmes with the highest standards of accountability and impact.

Prof Churchyard, the outgoing CEO, expressed his support for the transition. “It has been an incredible journey leading Aurum for the past 26 years, and I'm proud of what we've accomplished. I am confident that under Dave Clark’s leadership, with his passion for our mission and strategic insights, Aurum will make ever greater contributions to our communities and to global health," lauded Churchyard.

Upon his retirement as Group CEO, Prof Churchyard will assume the position of president emeritus to provide support to Prof Clark, pursue his own programme of research and continue to be an ambassador for Aurum.

As Aurum prepares for this leadership transition, the organisation remains committed to its core mission of improving health outcomes in Africa and beyond,” Dr Gule said. “The challenges facing global health are changing, and under Prof Clark’s leadership, Aurum will also evolve to directly address the most pressing challenges, using the most innovative methods, to take success to scale.

Notes to editors

About The Aurum Institute:

The Aurum Institute is a proudly African organisation whose mission is to generate evidence for policy and translate policy into practice to positively impact the health of communities globally. We partner with governments, the private sector and civil society to design and deliver high-quality care and treatment to people in developing communities.

About Professor Dave Clark, MBBCh, BCom, MBA, CD(SA)

Dr Dave Clark is an expert in global health management from Johannesburg, South Africa. He is currently the Group chief operations officer of The Aurum Institute. He was part of executive and clinical management of hospitals and health services in the gold subsidiary of the Anglo-American group up until 2004 before moving to Aurum. As an executive director and board member of Aurum, Dr Clark is strongly involved in all aspects of the healthcare research and delivery, as well as oversees all business services and strategic management of the company. His activities include the implementation of business and information technology solutions for financial, human resource, and research data management to support the work of the scientific and clinical departments.

Dr Clark’s strengths include an analytical mind with an emphasis on lateral thinking as well as an ability to draw operational teams together and motivate them to implement projects that deliver results. He has a particular interest in systems design and implementation and the development of governance and executive leadership for NGO’s and small companies.

Dr Clark qualified in medicine at Wits University in Johannesburg. He holds a master's degree in business administration and a Bachelor of Commerce Degree, as well as a diploma in health services management. Dave is also a Chartered Director (SA).

Dr Clark holds an adjunct professor appointment at Vanderbilt University, Nashville, Tennessee, and is an executive and non-executive board member of several companies.

About Professor Gavin Churchyard, MBBCh (WITS), FCP (SA), FRCP (Edin), MMed (Int Med), PhD (WITS)

Professor Gavin Churchyard is the founder and current Group chief executive officer of The Aurum Institute (NPC). He is a specialist physician (internal medicine) with a master’s degree in medicine and a doctorate degree in infectious diseases. He is a National Research Foundation A-rated scientist, an honorary professor at the University of Witwatersrand, School of Public Health, and an adjunct professor at Vanderbilt School of Medicine. He is the co-chair of the National Institutes of Health, Cross-Network TB vaccine Working Group, and the principal investigator on numerous TB vaccine and preventive treatment trials. He has published widely in the areas of TB and HIV treatment and prevention and contributed to international and national guidelines for TB.