Serac Healthcare has received positive feedback from the FDA in its End of Phase II Meeting for 99mTc-maraciclatide, a diagnostic imaging agent designed to visualize superficial peritoneal endometriosis (SPE). The development follows the FDA’s grant of Fast Track Designation to the agent in July 2024.
The imaging agent, used with single-photon emission computed tomography (SPECT-CT), aims to provide a non-invasive alternative to laparoscopy for diagnosing SPE in women aged 16 and older. Initial Phase II findings suggest promise in detecting SPE, which is currently difficult to visualize with ultrasound and MRI.
“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. We are looking forward to finalising the Phase III protocol with the FDA,” said David Hail, Chief Executive of Serac Healthcare.
The planned Phase III study will compare findings from women undergoing laparoscopic surgery for endometriosis with imaging results using 99mTc-maraciclatide and SPECT-CT prior to surgery.
Highlighting the significance of this development, Hail noted: “Chronic pain, fertility issues and depression are just some of the consequences that one in ten women with endometriosis are living with every day. A non-invasive test, particularly for early-stage disease which cannot easily be visualised by other imaging methods, and which accounts for eighty per cent of diagnoses by laparoscopic surgery, is desperately needed by the 190 million women worldwide suffering from this debilitating condition.”
The technology behind 99mTc-maraciclatide involves a radio-labelled tracer that binds to the cell adhesion protein αvβ3 integrin and images angiogenesis, the formation of new blood vessels crucial to the establishment and growth of endometriotic lesions.
The company is now working to finalize the protocol with the FDA to begin the Phase III program. The agent remains investigational and has not yet received approval from FDA or UK and European regulatory authorities.
