• Public-private collaboration to evaluate five antimicrobial agents across two combination regimens for treating both drug-susceptible and drug-resistant forms of TB with shorter treatment durations

August 17, 2022 – The Project to Accelerate New Treatments for Tuberculosis ("PAN-TB") collaboration announced today the execution of a joint development agreement ("JDA") supporting the progression of two investigational tuberculosis ("TB") combination treatment regimens into phase 2 clinical development. The collaboration will evaluate whether the novel regimens, which combine registered products and new chemical entities ("NCEs"), can effectively treat all forms of active pulmonary TB using substantially shorter treatment durations than existing drug regimens, with the goal of identifying a regimen suitable for phase 3 development.

TB is a major global cause of illness, disability and catastrophic household costs, and is one of the leading causes of death from an infectious disease worldwide, responsible for an estimated 1.5 million deaths per year. A shorter drug regimen that can treat both drug-susceptible and drug-resistant forms of TB in potentially three months or less could provide a significant benefit to both patients and health systems and may overcome the need for accompanying drug-resistance testing. 

Recognizing that no single organization produces the full range of drugs needed to respond to TB, the PAN-TB collaboration brings together philanthropic, non-profit and private sector organizations to accelerate the development of novel, shorter drug regimens to treat all forms of TB. The five antimicrobial agents to be evaluated under the new JDA, and the organizations contributing them, include:

• Bedaquiline; registered product for multidrug-resistant TB, Janssen Pharmaceutica NV, part of the Janssen Pharmaceutical Companies of Johnson & Johnson, and NCE for drug-sensitive TB, TB Alliance¹
• Delamanid; registered product, Otsuka Pharmaceutical Co., Ltd.
• Pretomanid; registered product, TB Alliance
• OPC-167832; NCE, Otsuka
• Sutezolid; NCE, TB Alliance, Medicines Patent Pool, Bill & Melinda Gates Medical Research Institute

The two investigational drug regimen combinations to be evaluated include:

• DBOS – delamanid, bedaquiline, OPC-167832 and sutezolid
• PBOS – pretomanid, bedaquiline, OPC-167832 and sutezolid

The planned phase 2 trials that will be supported by the JDA were designed by the PAN-TB collaboration and informed by the World Health Organization’s ("WHO") recently published position statement on the design of clinical trials for novel TB therapies.

New treatment regimens could help transform TB care. The most commonly used drug regimen for the treatment of drug-sensitive TB requires patients to take multiple drugs for up to six months with routine clinical monitoring. Patients with drug-resistant forms of TB can face longer and more complex treatment journeys, often with significant side effects that require increased monitoring. Accurate and rapid drug resistance testing is essential for early diagnosis of both drug-sensitive and drug-resistant TB, but access to testing can be limited due to high costs, technical challenges and other barriers.

The PAN-TB collaboration is a first-of-its-kind effort to accelerate development of a drug regimen capable of treating all forms of TB (a “pan-TB” regimen), focusing on advancing research through phase 2 clinical studies and identifying promising regimens for further development. The collaboration comprises Evotec, GSK, Janssen Pharmaceutica NV, Otsuka, TB Alliance, the Bill & Melinda Gates Medical Research Institute ("Gates MRI") and the Bill & Melinda Gates Foundation. The JDA announced today is among the four collaborators contributing drugs – Janssen Pharmaceutica NV, Otsuka, TB Alliance and the Bill & Melinda Gates Medical Research Institute. Gates MRI will also conduct the clinical studies.

Werner Lanthaler, PhD, CEO, Evotec, said: “Tuberculosis still has a significant impact on global health that needs to be addressed. The PAN-TB research group brings together global leaders in their particular fields. As Evotec we are dedicated to contributing to the research through our expertise and multi-modality platform, which can help validate drug candidates.”

Masanori Kawasaki, Global TB Project Leader, Otsuka Pharmaceutical Co. Ltd., said: “We are extremely proud to be moving forward within this unique collaboration towards the phase 2 b/c trial of a new universal treatment regimen. We are excited to be working closely with our colleagues in the Bill & Melinda Gates Medical Research Institute, Janssen Pharmaceutica NV and the TB Alliance to do all we can to bring a new treatment to patients whose options are limited. Otsuka is dedicated to research and development to eliminate tuberculosis. We extend our thanks to the Bill & Melinda Gates Foundation for bringing together leaders in the field of TB, towards the goal of ending TB for good.”

Ruxandra Draghia-Akli, MD, PhD, Global Head of Global Public Health R&D, Janssen Research & Development, LLC, said: “The Janssen Pharmaceutical Companies of Johnson & Johnson remain steadfast in our commitment to advancing research and development to create next-generation TB treatment regimens, as guided by our 10-year initiative to discover and develop new drugs to help end TB. Today, our medicine has become the backbone of WHO-recommended all-oral treatment regimens for nearly all DR-TB patients, and this agreement will allow us to explore further our medicine’s potential to help transform TB treatment for patients in need while maintaining its long-term effectiveness in the face of rising antimicrobial resistance.”

Mel Spigelman, MD, President and CEO, TB Alliance, said: “TB is becoming a greater and greater global health emergency. We are proud to be a member of the PAN-TB consortium to advance novel drug regimens that can much more effectively combat this deadly pandemic and save lives. This initiative is a significant advancement of our pioneering efforts that introduced and validated the concept of regimen development in TB.”

Emilio Emini, PhD, CEO, the Bill & Melinda Gates Medical Research Institute, said: “The Bill & Melinda Gates Medical Research Institute team looks forward to working with its PAN-TB collaboration partners in the execution of the phase 2 clinical studies evaluating the first two TB drug regimens for further development as potentially improved TB treatment options.”

About the Project to Accelerate New Treatments for Tuberculosis
The Project to Accelerate New Treatments for Tuberculosis (PAN-TB) is a first-of-its-kind collaboration among philanthropic, non-profit and private sectors that aims to accelerate the development of an investigational drug regimen capable of treating all forms of tuberculosis.

The PAN-TB collaboration will leverage members’ collective assets, resources and scientific expertise to identify and evaluate new drug regimens with an acceptable safety profile, that have the potential to treat both drug-sensitive and drug-resistant TB, and are better-tolerated, shorter in duration and simpler to use than existing options. The collaboration will focus on advancing research through phase 2 clinical efficacy studies in order to identify promising regimens for further development.

The PAN-TB collaboration plans to work closely and transparently with the European Regimen Accelerator for Tuberculosis (ERA4TB), which was launched in January 2020. New molecular entities identified by ERA4TB that show promise in initial human studies could later be incorporated into the PAN-TB collaboration’s later-stage, clinical research. Several organizations, including Evotec, GSK and Janssen Pharmaceutica NV, are members of both projects, which will help to ensure coordination across collaborations toward the common goal of advancing TB drug and regimen development.

The founding members of the PAN-TB collaboration are Evotec, GSK, Janssen Pharmaceutica NV, Otsuka Pharmaceutical Co., Ltd., based in Japan, the Bill & Melinda Gates Medical Research Institute and the Bill & Melinda Gates Foundation. Additional members may be announced in the future.

¹ Janssen provided the exclusive rights for developing and marketing bedaquiline for drug-sensitive TB to the TB Alliance in 2009

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