Serac Healthcare Announces Successful FDA End of Phase II Meeting for Endometriosis Imaging Agent

Feb. 5, 2025 — Serac Healthcare Ltd., a clinical radiopharmaceutical company developing an innovative molecular imaging agent, said it has received positive feedback from its End of Phase II Meeting with the US Food and Drug Administration (FDA) for the development of ^99mTc-maraciclatide as a diagnostic agent for use with single-photon emission computed tomography (SPECT-CT) for the visualization and diagnosis of superficial peritoneal endometriosis (SPE) in women aged 16 years of age and older.

Initial Phase II findings indicate that ^99mTc-maraciclatide has potential as a non-invasive test for the detection of SPE. SPE is not well visualized with current non-invasive imaging tools (ultrasound and MRI) and definitive diagnosis requires laparoscopy. The planned Phase III study will compare the findings from women undergoing laparoscopic surgery for endometriosis with imaging using ^99mTc-maraciclatide and SPECT-CT prior to surgery.

The FDA feedback on the Phase III study design follows their review of the Phase II results and builds on the grant of Fast Track Designation to ^99mTc maraciclatide in July 2024 as a diagnostic agent for use with SPECT-CT for the visualization and diagnosis of SPE in women of 16 years and older.

David Hail, Chief Executive of Serac Healthcare, commented, "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 finalizing the Phase III protocol with the FDA.”

“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 visualized 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 company is now finalizing the protocol and will be working with the FDA to prepare for the start of the Phase III program.

For more imformation, please visit www.serachealthcare.com.