FDA Supports Phase III Development of Novel Non-Invasive Endometriosis Imaging Test
Key Insights
Serac Healthcare (search) receives positive FDA feedback for 99mTc-maraciclatide, a diagnostic imaging agent designed to detect superficial peritoneal endometriosis (search) through SPECT-CT scanning.
The innovative imaging technology targets αvβ3 integrin protein and could provide a non-invasive alternative to laparoscopic surgery for diagnosing endometriosis (search) in women aged 16 and older.
Following Fast Track Designation in July 2024, the company is advancing to Phase III trials, addressing a critical need for the 190 million women worldwide affected by endometriosis (search).
Serac Healthcare (search) has achieved a significant milestone in developing a non-invasive diagnostic solution for endometriosis (search), following a successful End of Phase II Meeting with the FDA for their novel imaging agent, 99mTc-maraciclatide. This development marks a crucial step forward in addressing the diagnostic challenges faced by millions of women with endometriosis.
Innovative Diagnostic Approach
The diagnostic agent, designed to be used with single-photon emission computed tomography (SPECT-CT), specifically targets the visualization of superficial peritoneal endometriosis (search) (SPE). This condition has traditionally been difficult to detect using conventional imaging methods such as ultrasound and MRI, often requiring invasive laparoscopic surgery for definitive diagnosis.
The technology employs a radio-labelled tracer that specifically binds to the αvβ3 integrin cell adhesion protein, enabling the visualization of angiogenesis - the formation of new blood vessels that characterizes endometriotic lesions. This approach could revolutionize how endometriosis (search) is diagnosed, particularly in early-stage cases.
Clinical Impact and Market Need
"Chronic pain (search), fertility issues (search) and depression (search) are just some of the consequences that one in ten women with endometriosis (search) are living with every day," stated David Hail, Chief Executive of Serac Healthcare (search). He emphasized that early-stage disease, which accounts for 80% of diagnoses through laparoscopic surgery, is particularly challenging to visualize with current imaging methods.
The development of this non-invasive diagnostic tool could significantly impact the estimated 190 million women worldwide who suffer from this debilitating condition. Current diagnostic delays and the invasive nature of laparoscopic surgery often result in delayed treatment and prolonged suffering for patients.
Regulatory Progress and Next Steps
The FDA's positive feedback follows their grant of Fast Track Designation to 99mTc-maraciclatide in July 2024, highlighting the urgent need for improved diagnostic tools in this area. "We are delighted with the outcome of our End of Phase II Meeting with the FDA which provides us with a clear development path for maraciclatide," Hail commented.
The upcoming Phase III study will evaluate the imaging agent's effectiveness by comparing SPECT-CT imaging results using 99mTc-maraciclatide against findings from laparoscopic surgery in women with suspected endometriosis (search). While the agent shows promise, it remains investigational and awaits approval from FDA, UK, and European regulatory authorities.
Clinical Trial Design
The planned Phase III program will focus on women aged 16 and older, comparing the accuracy of 99mTc-maraciclatide imaging against the current gold standard of laparoscopic surgery. This validation process is crucial for establishing the technology's reliability as a non-invasive diagnostic alternative.