Serac Healthcare, a clinical radiopharmaceutical company specializing in innovative molecular imaging technologies, announced today that the US Food and Drug Administration (FDA) has granted Fast Track Designation to 99mTc-maraciclatide as a diagnostic SPECT-CT agent for the visualization and diagnosis of superficial peritoneal endometriosis in women aged 16 and older.
Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat or diagnose serious conditions and fill an unmet medical need. The criteria include improving the diagnosis of a serious condition where early diagnosis results in an improved outcome. This designation provides several benefits, such as eligibility for Accelerated Approval and Priority Review if relevant criteria are met, more frequent meetings with the FDA to discuss the drug’s development plan, and ensure appropriate data collection for drug approval. Additionally, it allows for more frequent written communication from the FDA regarding clinical trial designs and a Rolling Review, enabling completed sections of the New Drug Application (NDA) to be reviewed by the FDA rather than waiting for the entire application to be completed. These benefits are intended to reduce the time to approval in the US, allowing patients to benefit sooner.
David Hail, Chief Executive Officer of Serac Healthcare, commented: “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.”
Endometriosis is a common inflammatory disease affecting up to one in 10 women of childbearing age, approximately 190 million women worldwide. It occurs when tissue similar to the lining of the uterus is found outside the uterus, often causing significant pain and infertility. Diagnosing endometriosis is challenging due to varying symptoms that mimic other conditions, leading to an average delay of 7.5 years from symptom onset to diagnosis. Superficial peritoneal endometriosis (SPE), the earliest and most common form, comprises about 80% of all diagnoses. However, due to the small size of lesions, SPE is not well visualized with current non-invasive imaging tools, requiring laparoscopy for definitive diagnosis.
Serac Healthcare, founded to advance personalized medicine in the fields of endometriosis and inflammatory arthritis, aims to bring effective diagnostic tools to market. Their innovative molecular imaging agent, 99mTc-maraciclatide, is a radio-labelled tracer that binds with high affinity to the cell adhesion protein αvβ3 integrin and images angiogenesis (new blood vessel formation), critical to the establishment and growth of endometriotic lesions. Clinical trials in conditions like breast cancer, bone metastases, and rheumatoid arthritis, where angiogenesis plays a key role, have shown the agent to perform as expected and be well tolerated.
Preliminary data from the “Detecting Endometriosis expressed integrins using technetium-99m” (DETECT) imaging study demonstrated that 99mTc-maraciclatide correctly identified superficial peritoneal endometriosis in those confirmed by laparoscopy. The ongoing Phase II study is expected to complete later this year.
