SPECT agent could help guide lung disease treatments, new data suggest
An investigational molecular imaging agent could be a gamechanger for helping inform providers on how to best treat patients with interstitial lung disease (ILD).
New data from Serac Healthcare—a company that specializes in developing clinical radiopharmaceuticals—detail the utility of 99mTc‑maraciclatide for differentiating between active inflammation and fibrosis in patients with diagnosed or suspected ILD. The SPECT agent binds with high affinity to αvβ3 integrin, which is upregulated in vascular endothelial cells during angiogenesis. This is a key process of inflammation, and the ability to visualize it can help providers more accurately diagnose specific disease mechanisms.
This information is key in determining the best course of treatment for patients, as active inflammation and fibrosis represent different stages of lung disease progression.
Some key Phase 2 findings include:
The agent helps identify co-existent inflammation in patients with established fibrotic disease to inform treatment strategies.
It can be used to screen for ILD in rheumatoid arthritis (RA) patients based on established risk factors.
It enables early identification of RA-associated ILD for disease progression and can be used to monitor therapy response.
So far, the study has tested the agent in a group of patients with idiopathic pulmonary fibrosis (IPF) and fibrotic hypersensitivity pneumonitis (fHP). Findings suggest that each subgroup shows distinct uptake of 99mTc‑maraciclatide. Compared to health controls, target-to-background ratio (TBR)—a measurement of uptake in a tumor compared to healthy surrounding tissues—also was significantly higher among IPF and fHP patients. This information is critical in differentiating between different disease mechanisms.
“ILD is a pernicious and painful condition affecting millions of patients worldwide. Inflammatory and fibrotic disease have distinct pathophysiological mechanisms, prognostic implications, and therapeutic requirements, yet there is no non-invasive way of making this distinction,” Druin Burch, FCRP, scientific director of Serac Healthcare, said in a release on the findings. “If these results are replicated in a larger study, maraciclatide has the potential to have an immediate impact on clinical outcomes.”
“The ability to visualize inflammation non-invasively, and to distinguish it from fibrosis, addresses an urgent unmet need in ILD,” added David Hail, chief executive of Serac Healthcare. “For clinicians managing these patients, the ability to visualize and identify disease activity has the potential to inform and improve clinical decisions and also to enable the development of new therapies.”
In February, the imaging agent made its way onto the U.S. Food and Drug Administration’s Fast Track to clearance. The FDA’s Fast Track designation is reserved for drugs capable of treating serious conditions, especially those that lack effective therapeutics, which are expected to progress if left untreated. It expedites the review process and streamlines communication between the FDA, developers and researchers.
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