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Interview: We have to work together through multi-sector partnerships and collaborations to tackle TB

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Johnson & Johnson (J&J) recently entered into a partnership with the Institute of Microbial Technology (IMTECH), part of the Council of Scientific and Industrial Research (CSIR), to accelerate the discovery of innovative new treatments for tuberculosis (TB). Sanjiv Navangul, MD, Janssen India and Dr Anil Koul, Director, CSIR-IMTECH, give more details about the project and its objectives, in an interaction with Lakshmipriya Nair

The WHO Global report released in 2016 places India at the centre of the global TB crisis with an estimate of 2.8 million patients. How will J&J’s MoU with CSIR-IMTECH help forge a tool to deactivate this ticking time bomb?

Under the Memorandum of Understanding, scientists from Johnson & Johnson’s global public health team will work closely with scientists from CSIR-IMTECH, on a research and development programme to explore potentially more effective, safer, all-oral treatment regimens to tackle multidrug-resistant TB (MDR-TB), as well as new molecular entities to treat all tuberculosis (TB) patients.

Can you give us more details on the role of the stakeholders in this project?

Dr Anil Koul: IMTECH has world class TB research including state of art facilities. J&J has been involved in TB research for past 17 years and been successful in bringing new drug to patient of MDR-TB, Bedaquiline, which has been approved in 45 countries till date, including India which is home to more than quarter of the global TB population. By bringing the best of India TB drug discovery scientists, with a global team of expertise in pre-clinical and clinical drug development at J&J, we aim to deliver on national strategic goal of ‘Ending TB by 2025.’

CSIR-IMTECH as a potential discovery R&D partner can provide expertise in areas of bacterial energy metabolism – which is the target of combo therapy and all four targets work on the idea of synergistic combinations using bedaquiline as backbone. Johnson & Johnson will provide its broad pre-clinical and clinical development resources and experience. MDR-TB is a global threat and we are committed to develop new drugs and solution for treatment of this dreaded disease including in patients with HIV where this drug regimen will be compatible with all HIV medications. No drug-drug interactions are envisaged at this moment either with known HIV drugs are drugs against diabetes.

This partnership aims to explore a treatment regimen to tackle MDR-TB.

How it would help India achieve its goal of ending TB by 2025? How close are we towards the discovery of innovative new treatments for TB?

TB remains a significant challenge to India. While we have made great advances in recent years with the approval of new TB medicines, we realise that eliminating TB will require significant additional R&D into new drugs that could allow us to create novel combinations of shorter, more effective, safer, and all oral treatment regimens for MDR-TB.

By bringing together some of India’s brightest minds with our scientists, Johnson & Johnson’s partnership with CSIR-IMTECH will help advance the potential of Indian science and help accelerate the discovery of innovative new treatments for TB. The partnership will work on four new drugs to develop a universal regimen for TB. We hope the first human trials will commence in 2019.

It has been over a month since the MoU was signed. Can you give us an update on the progress of this partnership? Can you give us some details on the investment on this project and its deployment?

We are exchanging detailed discovery plans and identifying roles and responsibilities. In the coming weeks, a delegation from of Janssen scientists will be joining their colleagues at IMTECH to have a face to face kick off of the collaboration.

As a company which has a wide experience in TB research and development, can you tell us about the major strides that we have made in this sphere till date?
The partnership with CSIR-IMTECH builds on nearly 20 years of TB research and development by Johnson & Johnson, which led to the approval of bedaquiline, the first new TB medicine in nearly 50 years, and adds to existing partnerships at central and state levels in India to increase awareness, diagnosis and care, and broaden access to bedaquiline.

In March 2016, Janssen India and the Revised National Tuberculosis Control Program announced a Conditional Access Program (CAP) to provide bedaquiline free-of-charge for 600 patients across six sites in India. In April 2017, it was confirmed that the CAP would be expanded to additional TB patients across 156 sites.

What are the gaps in the current TB regiment that the project aims to plug?

Dr Anil Koul: We aim for an universal, oral and HIV compatible new drug regimen. The idea is to work on synergistic combination of drugs with bedaquiline. This potential collaboration aims to develop a completely new drug regimen for TB with:

  1. University treatment regimen, that can be used for treatment irrespective of background resistance profile and eliminates the need for drug -resistance testing,
  2. A significantly shorter treatment duration,
  3. An all oral combo therapy and that removes injectable and reduces pill burden,
  4. Better safety profile.

What are the major challenges and roadblocks that hinder TB research in India? What are the concerted steps needed to boost research and build on the existing knowledge base?

Dr Anil Koul: TB is a complex disease and we have a responsibility to work together through multi-sector partnerships and collaborations in the TB community to tackle this challenge. The Indian scientific community excels at early-stage research. We need to complement these strengths and bridge more concretely between discovery research and translational medicine development processes. This can be done through targeted capability building and a strengthened clinical research infrastructure. We hope our collaboration will build on early-stage research excellence in India and maximise expertise and resources from both the public and private sector to develop new, effective treatments for this deadly disease.

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