Serac Healthcare has secured fast track designation from the US Food and Drug Administration for 99mTc-maraciclatide, a SPECT-CT imaging agent developed to visualise inflammation in individuals with known or suspected interstitial lung disease (ILD).
The fast track pathway is intended to speed up the development and regulatory review of therapies and diagnostic tools that target serious conditions and address unmet medical needs. Interstitial lung disease encompasses more than 200 disorders that compromise lung function and are characterised by progressive inflammation, fibrosis and a gradual deterioration in quality of life. In clinical practice, distinguishing between inflammatory activity and fibrotic damage at an early stage is critical for guiding treatment decisions. However, achieving that differentiation remains highly challenging.
With fast track status in place, Serac Healthcare may benefit from a range of regulatory mechanisms designed to reduce the time required for approval in the United States. These include potential eligibility for accelerated approval and priority review. The designation also enables more frequent meetings and written correspondence with the FDA, alongside the option for rolling review of sections of a new drug application as they are finalised.
David Hail, Chief Executive Officer of Serac Healthcare, said: ‘‘The FDA’s Fast Track designation of maraciclatide signals the imperative for improved ILD diagnosis, assessment, and monitoring. ILD symptoms are non-specific and often present late in disease progression, making early detection extremely difficult.
“While symptom management therapies are available, including powerful anti-inflammatory agents, inappropriate administration can prove more detrimental than beneficial. A non-invasive 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.’’
99mTc-maraciclatide functions as a radiolabelled tracer with high affinity binding to αvβ3 integrin. This cell-adhesion molecule is up-regulated in vascular endothelial cells during angiogenesis, a biological process central to inflammation.
Early findings from the PRospective Evaluation of Interstitial Lung Disease progression with quantitative CT (PREDICT-ILD) trial, based on preliminary phase 2 data, suggest that the agent may enable visualisation of inflammation in patients with fibrotic ILD. Additional clinical results are anticipated later this year.
