It is essential to modernize TB treatment options and, even with recent progress, we must strive for better, shorter, and simpler treatment options for patients with all forms of TB.

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.

Most recently, in August 2022, the PAN-TB collaboration announced the execution of a joint development agreement (JDA) supporting the progression of two investigational 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.

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.

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.

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