Serac Healthcare has received fast track designation from the US Food and Drug Administration for 99mTc‑maraciclatide, a SPECT‑CT imaging agent intended for the visualisation of inflammation in patients with known or suspected interstitial lung disease.
Fast track is designed to accelerate the development and review of products that address serious conditions and unmet medical needs. ILD comprises more than 200 disorders that impair lung function and are marked by progressive inflammation, fibrosis and declining quality of life. Early and accurate differentiation between inflammation and fibrosis is vital for treatment decisions, yet remains extremely challenging.
The designation provides several potential advantages intended to shorten the time to approval in the US, including eligibility for accelerated approval and priority review, more frequent FDA meetings and written communication, and rolling review of sections of a new drug application as they are completed.
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 is a radiolabelled tracer that binds with high affinity to αvβ3 integrin, a cell‑adhesion molecule up‑regulated in vascular endothelial cells during angiogenesis, a key process in inflammation.
Preliminary phase 2 data from the PRospective Evaluation of Interstitial Lung Disease progression with quantitative CT (PREDICT‑ILD) trial indicate that visualisation of inflammation in people with fibrotic ILD may be feasible using the agent. Further clinical results are expected later this year.
