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Pre-DICT TB: Providing a Pathway Towards TB Eradication

Magda_Chlebus_EFPIA

Tuberculosis is not a disease that one immediately associates with the developed world, the ongoing and misguided presumption being that it is confined to the globe’s poorer regions and populations. There is also an ill-conceived assumption among more prosperous nations that tuberculosis was essentially eradicated in their respective geographical areas sometime during the latter half of the 20th century.

Statistics provided by the World Health Organization paint a very different picture, though. Estimates released in March 2014, state that tuberculosis caused some 35,000 deaths in Europe in 2012, mostly from eastern and central European countries, with approximately 353,000 new cases of the disease arising in the same year. In fact, of the 27 countries worldwide with a high burden of multidrug-resistant (MDR) TB, 15 are in the WHO European Region.

The disease picture on a global scale is even more harrowing: somewhere in the world, someone dies from tuberculosis every twenty seconds. This is the harsh reality, despite the fact that the disease has long been both preventable and curable.

Current treatment was developed more than thirty years ago in a very different regulatory environment from that of today and requires six months or more of combinations of antibiotics to ensure complete cure. The length and complexity of this regimen often results in non-compliance on the part of patients. In turn, this could be driving a rise in multidrug-resistant strains of TB that simply do not respond to the main first-line antibiotics.

As a result, we urgently need more effective drugs that can reduce treatment times.

However, arriving at a stage where we can easily provide innovative therapies for TB is complicated by the fact that getting a single new drug to the clinic takes more than five years and, using existing methods, developing a novel drug regimen sequentially would require at least 20 years.

What is therefore desperately needed is a new approach to finding the best new combinations of drugs in the most efficient and reliable way.

This is where PreDiCT-TB comes in. The IMI-funded PreDiCT-TB project aims to speed up the search for new, more effective combinations of treatments to tackle tuberculosis. Funded through a public-private partnership to the tune of €28.5 million, the project aims to develop an integrated set of laboratory-based models to generate essential data to indicate the most appropriate doses and combinations of drugs for patients.

The PreDICT project, which runs from May this year to the end of April 2017, will also see the establishment of a comprehensive database of patient data from previous and ongoing clinical trials that will help to evaluate the performance of combination anti-TB drug regimens in newly developed laboratory models. Better information from these novel models should lead to better designed clinical trials involving TB patients. And improved trial design should revolutionise the speed and effectiveness of TB drug discovery and development.

PreDiCT-TB’s ultimate realisation of better, more patient-friendly and shorter treatment regimens should dramatically increase successful patient compliance, which will result in comprehensive cures and a more stable basis from which to fight multidrug-resistant (MDR) strains of TB in the future.

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Magda_Chlebus_EFPIA

EFPIA Science Policy Director

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