FDA Fast Tracks 99mTc-maraciclatide for Diagnosing Superficial Peritoneal Endometriosis

LONDON, July 2, 2024 -- Serac Healthcare Limited, a company specializing in clinical radiopharmaceuticals, has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to their diagnostic agent 99mTc-maraciclatide. This agent is designed for the visualization and diagnosis of superficial peritoneal endometriosis in women aged 16 and older using the SPECT-CT imaging technique.

Fast Track Designation is a process the FDA uses to facilitate the development and expedite the review of drugs and diagnostic tools that address serious conditions and meet unmet medical needs. The criteria for Fast Track include providing improvements in diagnosing serious conditions where early detection can lead to better outcomes.

Endometriosis is a prevalent inflammatory disease impacting up to 10% of women of childbearing age, equating to about 190 million women globally. It occurs when tissue resembling the lining of the uterus appears outside the uterus, often in the pelvic area and sometimes in other parts of the body such as the lungs. This extra-uterine tissue can cause significant pain and fertility issues. Diagnosing endometriosis can be challenging due to its varied symptoms, which often mimic other conditions. On average, it takes 7.5 years from the onset of symptoms to achieve a diagnosis. Superficial peritoneal endometriosis (SPE) is the earliest and most common form of the disease, making up about 80% of diagnoses. However, SPE is not easily visualized using current non-invasive imaging methods like ultrasound and MRI, often necessitating laparoscopy for a definitive diagnosis.

Preliminary data from the "Detecting Endometriosis expressed integrins using technetium-99m" (DETECT) imaging study have shown that 99mTc-maraciclatide accurately identifies superficial peritoneal endometriosis, correlating with subsequent confirmation via laparoscopy. The ongoing Phase II study for this imaging agent is expected to conclude later this year.

The Fast Track designation offers several advantages, such as eligibility for Accelerated Approval and Priority Review if specific criteria are met. It also allows for more frequent meetings and written communications with the FDA to discuss the drug's development plan and gather appropriate data for approval. Additionally, it permits a Rolling Review, enabling companies to submit completed sections of their New Drug Application (NDA) for review rather than waiting until the entire application is ready, thereby potentially shortening the approval timeline.

David Hail, CEO of Serac Healthcare, stated, "The Fast Track designation for maraciclatide underscores the urgent need for better diagnostic methods for endometriosis. The average delay in diagnosing this condition, which affects 190 million women globally, is seven and a half years and often requires invasive laparoscopy. We are dedicated to collaborating with the FDA and clinicians to finalize the development of 99mTc-maraciclatide. A non-invasive test for earlier diagnosis of endometriosis would be a significant breakthrough in women's healthcare."

99mTc-maraciclatide is a radio-labelled tracer that binds with high affinity to the cell adhesion protein αvβ3 integrin and images angiogenesis, a process critical to the formation and growth of endometriotic lesions. Clinical trials across various conditions, including breast cancer, bone metastases, and rheumatoid arthritis, where angiogenesis is pivotal, have demonstrated the agent's expected performance and tolerability.

Currently, maraciclatide is for investigational use only and has not been approved by the FDA or other regulatory authorities in the UK and Europe.

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