Novel Biomarker for Progressive Pulmonary Fibrosis (PPF)

Serum exosome-derived pulmonary surfactant protein B (SFTPB), effective for identifying high-risk patients with progressive pulmonary fibrosis (PPF) and facilitating early therapeutic intervention

Advantages

  • Superior diagnostic performance compared to conventional biomarkers such as KL-6 and SP-D.
  • Expected to enable the identification of patients at high risk of fibrosis progression, facilitating early intervention with anti-fibrotic treatments that may improve prognosis

Technology Overview & Background

Interstitial pneumonia is a chronic, intractable condition characterized by irreversible lung fibrosis and encompasses over 200 related diseases. In 2022, a new classification was introduced, defining all forms of interstitial pneumonia other than idiopathic pulmonary fibrosis (IPF)—marked by progressive fibrosis and declining respiratory function—as Progressive Pulmonary Fibrosis (PPF). A study in France reported a median survival of 2.4 to 7.9 years for patients with PPF. Although anti-fibrotic agents have demonstrated efficacy in managing PPF, their impact is limited when administered during advanced stages of the disease. Early intervention is therefore critical to maximize therapeutic benefits. However, diagnosing PPF early has been challenging, as current criteria rely on a combination of deteriorating respiratory function, increased fibrosis on imaging, and worsening respiratory symptoms.

The inventors have conducted extensive research on biomarkers derived from extracellular vesicles (exosomes). Using state-of-the-art proteomics and single-cell analysis, they identified SFTPB, a biomarker found in serum exosomes, that is strongly associated with both the pathogenesis and progression of lung fibrosis. SFTPB is known to maintain alveolar structure through its surfactant activity. The level of SFTPB in serum exosomes correlates more closely with disease severity than conventional biomarkers KL-6 and SP-D, expecting to enable the early detection of patients at high risk of disease progression. This advancement is expected to facilitate early therapeutic interventions and improve patient outcomes.

Data

  • ROC curve analysis showed that SFTPB outperformed KL-6 and SP-D in predicting the progression of interstitial lung disease (ILD), defined by either >10% decline in %FVC, acute exacerbation, or death within one year.
  • In patients with ILD (excluding Idiopathic Pulmonary Fibrosis (IPF), SFTPB levels in serum exosomes showed a significant correlation with mortality, as demonstrated in the bottom panel of the results.

Publications

Enomoto, T.et al., JCI insight,2024
[DOI] https://doi.org/10.1172/jci.insight.177937

Patents

PCT/JP2022/032288

Principal Investigator & Academic Institution

Yoshito TAKEDA(Associate Professor, Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine)

Expectations

TECH MANAGE seeks collaboration with diagnostic or therapeutic companies interested in utilizing or further developing this innovation for PPF diagnosis, therapeutic efficacy assessment, companion diagnostics, etc. We welcome inquiries and can facilitate discussions with the principal investigator of this groundbreaking invention.

Please do not hesitate to reach out with any inquiries.

 

Project No.TT-04898

 

Other than Medicine

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