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A collaboration called The Project to Accelerate New Treatments for Tuberculosis (PAN-TB) was announced yesterday (August 17). The joint development agreement (JDA) will support the progression of two investigational tuberculosis (TB) combination treatment regimens into phase 2 clinical development. The collaboration is made up of organizations contributing five antimicrobial agents. Active pulmonary TB Together they will evaluate whether the 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. Drug regimens The collaborators acknowledge that no single organization produces the full range of drugs needed to respond to TB, and say PAN-TB 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. One of the drugs is called Bedaquiline and it is a registered product for multidrug-resistant TB, managed by Janssen Pharmaceutica NV, part of the Janssen Pharmaceutical Companies of Johnson & Johnson, and NCE for drug-sensitive TB, from TB Alliance. The second is called delamanid a registered product from Otsuka Pharmaceutical Co., Ltd and the third is pretomanid another product registered by TB Alliance followed by OPC-167832 an NCE by Otsuka and finally there is sutezolid which is an NCE brought by 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 alongside PBOS – pretomanid, bedaquiline, OPC-167832 and sutezolid. Unique collaboration 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." 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. Clinical monitoring 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. Mel Spigelman, president and CEO, at 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.” The PAN-TB project: a promising collaboration 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. Ruxandra Draghia-Akli, managing director at Janssen Research and 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.” Investigational 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. Emilio Emini, CEO at the Bill & Melinda Gates Medical Research Institute, said: “The 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.”

TB Alliance

Collaboration to advance investigational tuberculosis drug treatments

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