#London #United Kingdom #FDA #Endometriosis #Serac Healthcare

Serac Healthcare's Promising FDA Feedback on Imaging for Endometriosis

In a significant stride for women's health, Serac Healthcare Limited recently announced positive outcomes from their End of Phase II Meeting with the US Food and Drug Administration (FDA). The meeting focused on the development of 99mTc-maraciclatide, an innovative radiopharmaceutical designed for the non-invasive imaging and diagnosis of superficial peritoneal endometriosis (SPE) through single-photon emission computed tomography (SPECT-CT).

The Need for Better Diagnosis

Endometriosis is a chronic, often painful condition affecting millions of women worldwide. It occurs when tissue similar to the lining inside the uterus grows outside of it, leading to severe symptoms such as chronic pain, fertility problems, and depression. One in ten women are estimated to be affected, yet diagnosis can be a long and arduous process due to the inadequacies of current imaging methods like ultrasound and MRI, which often fail to visualize SPE accurately. As a result, many women are subject to invasive diagnostic procedures such as laparoscopy.

Recognizing the unmet need for a reliable and non-invasive diagnostic test, Serac's 99mTc-maraciclatide presents a promising alternative. It binds with high affinity to αvβ3 integrin, a cell adhesion protein associated with angiogenesis, which is critical in the establishment and growth of endometriotic lesions.

Positive FDA Response

The FDA's favorable feedback comes after reviewing the compelling results from Phase II trials, which suggested that 99mTc-maraciclatide could serve as an effective tool for detecting SPE. The upcoming Phase III study aims to compare findings from women undergoing laparoscopic surgeries for endometriosis with pre-surgical imaging conducted via SPECT-CT and the innovative imaging agent. This design will enhance understanding of the efficacy of 99mTc-maraciclatide as a diagnostic tool, potentially transforming the standard for endometriosis diagnosis.

David Hail, the Chief Executive of Serac Healthcare, expressed optimism about the meeting's outcomes, remarking, "The feedback from the FDA provides us with a clear development path for maraciclatide. We are looking forward to finalizing the Phase III protocol with the FDA."

A Solution for Millions

The implications of this development extend far beyond technical innovation; it addresses a critical gap in women's healthcare. With approximately 190 million women globally suffering from endometriosis, the need for a non-invasive test is urgent. Most cases of SPE currently lead to 80% of diagnoses by laparoscopic surgery, highlighting the demand for a solution that can facilitate early identification and treatment.

Hail further explained the significance of this advancement: "Chronic pain, fertility issues, and depression are just some of the consequences faced by women living with endometriosis every day. This non-invasive test is desperately needed, particularly for early-stage disease which cannot easily be visualized by existing imaging methods."

Conclusion

As Serac Healthcare prepares to initiate its Phase III program, the biomedical community watches closely. The commitment to advancing technologies that prioritize patient comfort and diagnostic accuracy is a step forward not only for Serac but for women's health as a whole. While 99mTc-maraciclatide is still undergoing investigation and has yet to receive full FDA approval, the feedback thus far promises significant strides in combating endometriosis through accurate imaging and ultimately, improved patient outcomes.

For more information about Serac Healthcare and its initiatives, visit Serac Healthcare Ltd.