New study to explore novel marker in interstitial lung disease prognosis

Researchers at the University of Exeter and clinical radiopharmaceutical company Serac Healthcare Ltd are researching a new molecular imaging marker which could help to detect disease progression sooner.

The novel imaging agent 99mTc-maraciclatide has been used to scan the first patient with the aim of evaluating the marker’s potential for predicting interstitial lung disease in a Phase II study titled ‘PRospective Evaluation of Interstitial Lung Disease progression with quantitative CT’ (“PREDICT-ILD”).

Interstitial lung diseases (ILD) are a heterogenous group of over 200 irreversible conditions with varying degrees of inflammation that, without treatment, lead to scarring (fibrosis) of the lining of the lungs. It affects more than 150,000 people in the UK, with an incidence of 2,000-4,000 and causes significant morbidity and mortality. It is estimated that lung scarring results in 1% of deaths in the UK. The progression of Interstitial lung diseases is unpredictable, making prognostication challenging and creating barriers to effective drug development.

Therapies are available that can slow disease progression in some patients, however current limitations in diagnosis mean that determining the most suitable treatment is challenging, and prescribing the wrong treatment can make the condition worse. For example, certain medications are known to be effective at treating inflammation (which can be a feature of this disease) but can be detrimental in patients with fibrotic disease. Understanding the mechanisms that drive the progression of ILD is an urgent research priority.

The PREDICT-ILD study, led by Professor Chris Scotton, Associate Professor in Respiratory Biomedicine and Dr Giles Dixon, Senior Clinical Research Fellow, both at Exeter, is majorly funded by the Wellcome Trust’s GW4-CAT PhD Programme for Health Professionals.

David Hail, Chief Executive of Serac Healthcare, said: “The distinction between ILD conditions which are characterised by scarring and inflammation is crucial as this determines the appropriate treatment.

“A molecular imaging marker with the potential to differentiate between early-stage inflammation and the fibrosis it causes could have a significant impact on improving patient outcomes, as well as the development of new therapies. We are looking forward to working with the University of Exeter to evaluate maraciclatide’s potential in this new indication.”

Professor Michael Gibbons, Senior Investigator Fellow, NIHR Exeter Biomedical Research Centre, and Consultant Respiratory Physician, Royal Devon University Healthcare NHS Trust, said:

“Being able to detect disease progression sooner and thereby enabling earlier access to disease modifying treatments to appropriate patients would represent a step change in the treatment of this incurable condition. We are excited to be working with Serac Healthcare to evaluate whether maraciclatide could play a part to bring precision medicine to this patient population.”

The 99mTc-maraciclatide study is being facilitated by the Nuclear Medicine Department at the Royal United Hospitals, Bath and is supported by specialist radiologists Dr David Little and Dr Jonathan Rodrigues and specialist ILD physicians Dr Shaney Barratt and Professor Michael Gibbons. The study is also supported by the University of Exeter’s EPSRC Hub for Quantitative Modelling in Healthcare under the guidance of Professor Krasimira Tsaneva-Atanasova. Professor Michael Gibbons is also a Senior Investigator Fellow at the NIHR Exeter Biomedical Research Centre.

99mTc-maraciclatide is for investigational use only and is not approved by the FDA or UK and European regulatory authorities. *