Otsuka Pharmaceutical Co., Ltd.

August 18, 2022

PAN-TB Collaboration to Advance Investigational Tuberculosis Drug Regimens
to Phase 2 Clinical Trials

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

The Project to Accelerate New Treatments for Tuberculosis (PAN-TB) collaboration announces 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:

  • Delamanid; registered product, Otsuka Pharmaceutical Co., Ltd.
  • 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 Alliance
  • 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.

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."