Phase II PREDICT-ILD Imaging Study Begins in Interstitial Lung Disease

LONDON, Sept. 10, 2024 — Serac Healthcare Limited, a clinical radiopharmaceutical company focused on developing novel molecular imaging technologies, along with the University of Exeter, have announced the first patient scan using the innovative molecular SPECT imaging agent 99mTc-maraciclatide. This is part of a Phase II study named 'PRospective Evaluation of Interstitial Lung Disease progression with quantitative CT (PREDICT-ILD)'.

The main goal of the ongoing study is to determine the effectiveness of quantitative computed tomography (CT) for detecting the progression of interstitial lung disease (ILD). A new sub-study within this research is now assessing 99mTc-maraciclatide as an imaging marker to forecast disease progression in a subset of PREDICT-ILD participants. Currently, the PREDICT-ILD study is recruiting patients from three NHS sites in South-West England: North Bristol NHS Trust (NBT), Royal United Hospitals (RUH) NHS Foundation Trust, and Royal Devon University Healthcare NHS Foundation Trust.

The study is led by Co-chief investigators Professor Chris Scotton and Dr. Giles Dixon from the University of Exeter, which is recognized globally for its lung disease research. PREDICT-ILD is primarily funded by the Wellcome Trust GW4-CAT HP PhD Programme for Health Professionals.

The sub-study aims to assess the feasibility of using 99mTc-maraciclatide to evaluate disease activity by comparing the uptake of this imaging agent between participants with idiopathic pulmonary fibrosis (IPF), non-IPF fibrosing-ILD, and healthy controls matched for age, sex, and ethnicity. Secondary objectives include evaluating the potential of 99mTc-maraciclatide to identify αvβ3 activity and predict disease progression in fibrosing ILD participants. Overall, the study will recruit 69 participants, with 15 specifically for the sub-study.

Interstitial lung diseases encompass over 200 irreversible conditions marked by varying degrees of inflammation, leading to lung scarring or fibrosis without treatment. Affecting over 150,000 people in the UK, the disease has an incidence rate of 2,000-4,000 and results in significant morbidity and mortality, including 1% of deaths in the UK. The unpredictable progression of ILD complicates prognostication and creates challenges in developing effective treatments. Existing therapies can slow disease progression in some patients, but current diagnostic limitations make it difficult to determine the most effective treatment, with inappropriate medications potentially worsening the condition.

David Hail, Chief Executive of Serac Healthcare, emphasized the importance of differentiating between ILD characterized by scarring and inflammation. He noted that a molecular imaging marker capable of distinguishing early-stage inflammation from fibrosis could significantly improve patient outcomes and aid in developing new therapies. Hail expressed enthusiasm for working with the University of Exeter to evaluate maraciclatide's potential in this new application.

Professor Michael Gibbons, Senior Investigator Fellow at the NIHR Exeter Biomedical Research Centre and Consultant Respiratory Physician at Royal Devon University Healthcare NHS Trust, highlighted the potential benefits of detecting disease progression earlier. He noted that providing earlier access to disease-modifying treatments could represent a significant advancement in treating this incurable condition. Gibbons expressed excitement about collaborating with Serac Healthcare to determine if maraciclatide could contribute to precision medicine for this patient population.

The sub-study is supported by the Nuclear Medicine Department at the RUH, Bath, with contributions from specialist radiologists Dr. David Little and Dr. Jonathan Rodrigues, as well as ILD specialists Dr. Shaney Barratt and Professor Michael Gibbons. Additional support comes from the University of Exeter's EPSRC Hub for Quantitative Modelling in Healthcare, led by Professor Krasimira Tsaneva-Atanasova. Dr. Michael Gibbons is also a Senior Investigator Fellow at the NIHR Exeter Biomedical Research Centre.

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

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