Endometriosis imaging agent impresses at clinical trials

A new imaging agent that could be a game changer for the diagnosis and management of endometriosis is one step closer to making its way into clinical practice. 

On Wednesday, Serac Healthcare—a clinical radiopharmaceutical development company—announced they had received positive feedback from the U.S. Food and Drug Administration regarding the use of its new molecular imaging agent, 99mTc-maraciclatide, following its End of Phase 2 meeting. The agent is being developed as a non-invasive diagnostic tool for detecting superficial peritoneal endometriosis (SPE) using SPECT-CT imaging. 

Diagnosing SPE can be an arduous process. It often requires laparoscopy, as ultrasound and MRI frequently fail to detect the painful, sometimes debilitating condition, especially in its early stages. But initial Phase 2 trial results signal that 99mTc-maraciclatide's targeted binding capabilities could provide a less invasive alternative to surgery for women 16 and older.  

The FDA’s feedback builds on its prior decision to grant the radiotracer Fast Track Designation back in July 2024, highlighting an urgent need for improved diagnostic options. 

“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,” Serac Healthcare CEO David Hail said in an announcement. “We are delighted with the outcome of our FDA meeting, which gives us a clear path forward for maraciclatide. A non-invasive test for early-stage disease, which accounts for 80% of laparoscopic diagnoses, is desperately needed.” 

The upcoming Phase 3 study will compare the agent’s imaging performance to findings from laparoscopic surgery in patients with suspected endometriosis. Serac is now finalizing the study protocol and working with the FDA to prepare for trial initiation.