FDA fast tracks SPECT imaging agent targeted toward interstitial lung disease
Serac Healthcare’s promising new SPECT imaging agent just made its way onto the U.S. Food and Drug Administration’s Fast Track to clearance.
The agent, 99mTc‑maraciclatide, was designed to target inflammation in the lungs due to known or suspected interstitial lung disease. It 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.
Inflammation is a hallmark of such lung diseases and can lead to progressively worsening pulmonary function and quality of life. Experts are hopeful the new agent will help accurately differentiate between inflammation and fibrosis—a critical, currently unmet need—to determine the best course of treatment.
‘‘The FDA’s Fast Track designation of maraciclatide signals the imperative for improved [interstitial lung disease] diagnosis, assessment and monitoring,” Serac Healthcare CEO David Hail said in an announcement. “A noninvasive imaging solution capable of distinguishing inflammation and fibrosis predominant ILD has the potential to meaningfully advance early diagnosis, change the treatment paradigm and improve patient outcomes," he added later.
Data from phase 2 clinical trials indicate that the agent improves the visualization of fibrotic changes in patients with known or suspected lung disease. More information related to the drug's utility should be released later this year.
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.
Learn more here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.