Welcome to Respiratory Futures. We’re keen to share more about your partnership and its research programme with our readers.
What are the current trends in respiratory medicine research?
Mark Samuels: Precision medicine is an emerging approach to the treatment and diagnosis of disease that takes into account variations in a patient’s genes, environment and lifestyle.
It is essentially about giving the right drug to the right patient at the right time and has been a focus in cancer therapy for some time. This approach is now being adopted across many chronic diseases, including asthma and COPD initially within respiratory disease.
Today a number of new targeted therapies are in development, under regulatory review and have recently become available for the treatment of severe uncontrolled asthma, with additional respiratory indications expected to follow. For patients who are successfully treated with precision medicine, this could mean decreased treatment burden, less time in hospital and improved outcomes.
Respiratory diseases, such as asthma and idiopathic pulmonary fibrosis (IPF), are on the rise. The NHS spends more than £1bn a year on asthma treatments alone and two new treatments for IPF have emerged in the last four years but at a cost of £24,000 per patient per year. If therapies can be targeted specifically to those patients who will respond, other patients will be spared from ineffective treatments that may bring unwanted side effects. Put simply, the NHS will be able to make better use of its resources by targeting drugs at those people who can benefit.
What are the challenges?
MS: It is evident that the days of giving everyone a drug so that the whole population feels the benefit are unsustainable. However, precision medicine also comes at some cost.
Drug development is expensive. The cost of pre-clinical testing, clinical trials, regulatory approval and manufacturing adds up and will need to be recouped in sales. So if a small patient group is being targeted, then the potential cost of the drug could be higher. More favourably, precision medicine could also reduce development costs by identifying early-on those patients more likely to benefit from experimental therapies.
How is the National Institute for Health Research (NIHR) equipped to address this?
MS: The NIHR’s Translational Research Partnership in inflammatory respiratory disease was established to bring together the UK's leading academic and clinical centres for experimental medicine and translational research into a ready-formed partnership of Universities and NHS hospitals. It provides the life sciences industry with an effective platform for experimental medicine and early development of new drugs and diagnostics. This includes the potential to carry out biomarker and mechanism-of-action studies before, or in parallel with, first-in-human studies, as well as access to well-characterised patient cohorts to support proof-of-concept work.
Access to this translational research expertise gives the potential for both faster and more cost-effective early clinical development, with more informed go/no-go decision-making based on data from patients and precision medicine approaches.
What is exciting about research into respiratory disease at this time?
Professor Chris Brightling: Precision medicine approaches offer hope to patients with conditions that are difficult to manage. For example, a quarter of a million people in the UK are unable to get good control of their asthma and, as a result, suffer frequent, severe and sometimes life-threatening attacks.
The NIHR Translational Research Partnership in inflammatory respiratory disease is currently undertaking a study with AstraZeneca on a new drug (an anti-IL-13 anti inflammatory injectable drug called tralokinumab) that could help severe uncontrolled patients whose asthma is driven by IL-13 inflammation.
Tralokinumab is a human monoclonal antibody that works specifically by blocking the effects of the signalling protein IL-13 that is a key mediator in the pathogenesis of asthmatic disease.
The precision medicine study aims to understand the mechanisms behind the disease to better identify which patients would respond to treatment. It involves taking samples from blood, biopsies from the airway lining (including sputum samples), and imaging via CT scans. The researchers are investigating how the drug works by looking at its impact on inflammatory cells and at the changes in the structure of the airway, using the combination of standard breathing tests (lung function) and CT scans.
Thank you both for speaking with us.
The British Thoracic Society Winter Meeting 2016 had a precision medicine theme. A range of international speakers, together with NIHR's national experts, shared the very latest advances in the clinical, translational and basic science of lung disease.
These speakers included several NIHR Translational Research Partnership investigators:
- Dr Ling-Pei Ho
- Professor Wisia Wedzicha
- Professor Liam Heaney
- Dr Joanna Porter
- Dr Toby Maher.