Study published in The Lancet signals breakthrough in endometriosis diagnosis

The Nuffield Department of Women’s & Reproductive Health at the University of Oxford, together with Serac Healthcare Limited announces the publication of Phase 2 data in The Lancet Obstetrics and Gynaecology. The findings highlight the potential of the novel molecular imaging agent, 99mTc-maraciclatide, as a non-invasive tool for the diagnosis and monitoring of endometriosis.

The paper published online today highlights that ^99mTc-maraciclatide has potential as:

• A novel non-invasive diagnostic test, particularly for superficial peritoneal endometriosis (SPE), which cannot be reliably detected by conventional imaging techniques and currently requires laparoscopic surgery for definitive diagnosis
• A tool to enable disease monitoring, eliminating uncertainty around disease recurrence
• A marker of treatment response, empowering the development of novel therapies

^99mTc-maraciclatide is a gamma-emitting radiotracer that binds to αvβ3 integrin, which is upregulated during angiogenesis (new blood vessel formation), a cardinal feature of inflammatory diseases. The DETECT study describes, for the first time, the use of ^99mTc-maraciclatide as a potential tool for the visualisation and diagnosis of endometriosis.

Key findings:

• The DETECT study demonstrated a high correlation between locations of maraciclatide uptake and laparoscopy across all types of endometriotic lesions, including superficial peritoneal endometriosis (SPE). SPE is the earliest stage of endometriosis, which is found in 80 per cent of all laparoscopically diagnosed disease

• Imaging with ^99mTc-maraciclatide visualised endometriosis, detecting disease missed by conventional imaging methods

• Imaging results were concordant with the surgical presence or absence of endometriosis in 16/19 cases, with endometriosis imaged in 14/17 surgically positive participants, including two cases of thoracic endometriosis

• No false positives were reported in this study

• ^99mTc-maraciclatide imaging was able to detect lesions across all endometriosis subtypes supporting the applicability of the scan to various patient groups

• ^99mTc-maraciclatide was well tolerated and patient acceptability was high

Dr Tatjana Gibbons, lead author on the paper and investigator on the study from the Nuffield Department of Women’s and Reproductive Health, University of Oxford added, 

“These exciting findings indicate that maraciclatide offers a highly promising diagnostic and monitoring tool, particularly for superficial peritoneal endometriosis, which is the most common and yet the hardest type of endometriosis to identify.

“We are hugely grateful to the patients who have participated in the DETECT study without whom investigating this diagnostic approach would not have been possible.”

Professor Christian Becker, Co-Director of the Endometriosis CaRe Centre in Oxford, co-lead on the study and joint senior co-author on the paper, added:

“Novel, non-invasive diagnostic tests for endometriosis are a global research priority. The diagnostic challenge of endometriosis, which presents with varied and non-specific symptoms, is exacerbated by an absence of clinically validated biomarkers and the limitations of currently available imaging techniques. If these Phase II results are reproduced in the Phase III studies, maraciclatide has the potential to be an extremely valuable tool, as it could both reduce diagnostic delays and provide a validated endpoint for the development of new therapeutics.”

David Hail, CEO of Serac Healthcare, commented:

“The completion and publication of this clinical study marks a pivotal achievement for Serac Healthcare. These data, from a representative patient population, including women receiving hormone therapy, provide  evidence of maraciclatide's anticipated real-world performance.

“With FDA Fast Track Designation and agreed Phase III study designs, we are now advancing to validate these findings in larger trials and progress to regulatory submission.”

Professor Krina Zondervan, Co-Director of the Endometriosis CaRe Centre, Head of Department at the Nuffield Department of Women’s and Reproductive Health, Co-theme Lead for the NIHR Oxford Biomedical Research Centre’s Surgical Innovation Theme, co-lead on the study and joint senior co-author on the paper, said:

“Superficial peritoneal endometriosis, the most prevalent subtype of endometriosis, currently evades reliable detection, leaving women no choice for diagnosis other than invasive surgery. If these results are confirmed in larger Phase III studies, imaging with maraciclatide could transform clinical research and practice and potentially empower the development of treatments for women across the globe.”

The study was co-led by Professor Christian Becker, Co-Director of the Endometriosis CaRe Centre in Oxford, together with Professor Krina Zondervan, Co-Director of the Endometriosis CaRe Centre and Head of Department at the Nuffield Department of Women’s and Reproductive Health at the University of Oxford. The study was funded by the  NIHR Oxford Biomedical Research Centre and Serac Healthcare. Scans were performed at the Royal United Hospital, Bath.

About the Phase 2 trial:

This was an exploratory, open-label, single-centre, phase 2 study evaluating preoperative imaging in 20 individuals with suspected or confirmed pelvic or thoracic endometriosis using a SPECT-CT, with intravenous ^99mTc-maraciclatide. The primary outcome was alignment of radiological and surgical findings in those patients completing both imaging and surgery. The surgical report on lesion type and location was compared to images for alignment.

Ten of the participants with SPE had prior imaging with traditional modalities (transvaginal (TV) ultrasound and/or MRI) in the last 12 months, none of which had detected SPE.

Phase III multi-centre international studies are due to start later this year.

-ENDS-

Maraciclatide is for investigational use only and is not approved by the FDA or UK and European regulatory authorities.

For more information, please contact:

Nuffield Department of Women’s & Reproductive Health, University of Oxford www.wrh.ox.ac.uk

Rob Phillips, Communications   (+44 (0)7730 527341)

rob.phillips@wrh.ox.ac.uk

Serac Healthcare Ltd www.serachealthcare.com

Francetta Carr, Communications (+44 (0)7711 010820)

francettacarr@seraclifesciences.com

Notes to Editors

Nuffield Department of Women's & Reproductive Health

The Nuffield Department of Women’s & Reproductive Health (NDWRH) at the University of Oxford is a world-leading centre for research, clinical studies and teaching in women’s health and reproduction. Established in 1937, the Department is internationally recognised for its pioneering research, clinical expertise, and postgraduate education. Through innovative, evidence-based research, NDWRH is committed to improving standards, providing better health outcomes, and advancing high-quality care in women’s and reproductive health. For further information, please visit www.wrh.ox.ac.uk  

Serac Healthcare Ltd

Serac Healthcare is a clinical radiopharmaceutical company with deep expertise in discovering, developing and commercialising innovative molecular imaging technologies. Using these targeted technologies to underpin personalised medicine in the fields of endometriosis, inflammatory arthritis and interstitial lung disease, Serac Healthcare is focused on bringing to market effective tools to accelerate diagnosis, and to deliver earlier and more effective treatment decisions. Serac Healthcare Ltd is a wholly owned subsidiary of Serac Life Sciences Limited. www.serachealthcare.com

The DETECT study

The study is jointly sponsored by the Oxford Endometriosis CaRe Centre and the Nuffield Department of Women’s and Reproductive Health, University of Oxford, and funded by Serac Healthcare Ltd who are providing the experimental imaging marker ^99mTc-maraciclatide. Further details are available on ClinicalTrials.gov here.

^99mTc-maraciclatide

^99mTc-maraciclatide is a radio-labelled tracer which binds with high affinity to the cell adhesion protein α_vβ₃ integrin and images angiogenesis (new blood vessel formation) which is known to be critical to the establishment and growth of endometriotic lesions.

In July 2024, ^99mTc-maraciclatide was granted Fast Track Designation as a diagnostic agent for use with SPECT CT for the visualisation and diagnosis of superficial peritoneal endometriosis in women of 16 years and older. The FDA Fast track is intended to facilitate the development and expedite the review of drugs to treat (or in our case, diagnose) serious conditions and fill an unmet medical need. Criteria include improving the diagnosis of a serious condition where early diagnosis results in an improved outcome.

Endometriosis

Endometriosis is a common inflammatory disease that affects up to one in 10 women of childbearing age, about 190 million women worldwide. Endometriosis occurs when tissue similar to the lining of the uterus is found outside the uterus, predominantly in the pelvis, but sometimes also elsewhere in the body, e.g. lungs. The presence of this ectopic endometrial tissue can lead to inflammation and distortion of normal anatomy, which can cause significant pain and infertility. Those with endometriosis typically experience an 8-12 year delay to diagnosis, requiring numerous visits to physicians and hospitals, along with multiple scans.