Serac Healthcare Limited, a clinical radiopharmaceutical company developing an innovative molecular imaging agent, has officially secured FDA’s Fast Track Designation for its 99mTc-maraciclatide as a diagnostic SPECT-CT agent. According to certain reports, the stated agent can be used for visualizing and diagnosing superficial peritoneal endometriosis in women of 16 years and older. Before we dig any further into the solution, we must acknowledge how endometriosis is actually a pretty common inflammatory disease that affects up to one in every 10 women of childbearing age, translating to over 190 million women worldwide. It occurs, in essence, when tissue similar to the lining of the uterus is found outside the uterus, usually in the pelvis. Not just there, the stated lining sometimes can also be found in another place within the individual’s body (e.g. the lungs). Anyway, in both the cases, this displacement can lead to significant pain and infertility. Making things complicated, though, is the fact that diagnosing endometriosis is a real challenge, as its symptoms can vary considerably and mimic those of other conditions. Such a reality means there is an average delay of 7.5 years from first symptom onset to diagnosis. Here the need for better diagnosis of superficial peritoneal endometriosis, in particular, becomes more prevalent once you take into account how it is the earliest and most common form of endometriosis, comprising approximately 80% of all diagnoses. However, given its plaque-like nature and generally small size of lesions, the condition is often not undetected with current non-invasive imaging tools (ultrasound and MRI), leaving laparoscopy as the only reliable alternative
Having referred to the problem statement, we now must shift our focus towards the solution and how exactly it will improve upon the given situation. To put it simply, 99mTc-maraciclatide is a radio-labelled tracer which binds with high affinity to the cell adhesion protein αvβ3 integrin and images angiogenesis (new blood vessel formation), something which is known to be critical to the establishment and growth of endometriotic lesions. Thus far, the solution has shown its potential across multiple clinical trials that were conducted to aid things in conditions like breast cancer, bone metastases and rheumatoid arthritis. Another piece of validation for the component comes from “Detecting Endometriosis expressed integrins using technetium-99m” (DETECT) imaging study, where it was demonstrated that 99mTc-maraciclatide correctly identified superficial peritoneal endometriosis in those who went on to have this early-stage endometriosis confirmed by laparoscopy. As an extension of that effort, there is a Phase II study currently being conducted to further validate the preliminary data, with its conclusion penciled in at some point later this year.
“Granting Fast Track designation to maraciclatide highlights the FDA’s recognition of the critical need for improved diagnosis of endometriosis. The average delay for diagnosis of this condition, which affects 190 million women worldwide, is seven and a half years and is often only possible with laparoscopy. We are committed to working closely with the FDA and clinicians to complete the development of 99mTc-maraciclatide. A non-invasive test which could be used for earlier diagnosis of endometriosis would represent a major advance in women’s healthcare,” said David Hail, Chief Executive Officer of Serac Healthcare Limited.
As for the Fast Track Designation, it is basically a process designed to facilitate the development and expedite the review of drugs that treat or diagnose serious conditions to fill an unmet medical need. To qualify for this designation, the solution’s early diagnostic capabilities must improve the eventual outcome.