The FDA has granted Fast Track Designation to 99mTc-maraciclatide for diagnosing superficial peritoneal endometriosis (SPE) in patients aged 16 years and older, according to Serac Healthcare Limited, a clinical radiopharmaceutical company.1
Takeaways
- The FDA granted Fast Track Designation to 99mTc-maraciclatide, a diagnostic tool for superficial peritoneal endometriosis, aiding in faster development and review to meet critical unmet medical needs.
- Endometriosis affects up to 1 in 10 reproductive-aged women, causing pain and infertility. Its diagnosis is difficult because of varying symptoms and current diagnostic tools' limitations.
- Women with endometriosis have higher risks of mental health conditions, with 67% diagnosed with a mental health issue compared to 51.2% of those without the condition. There is also an increased risk of severe mental health issues and self-harm.
- 99mTc-maraciclatide, developed by Serac Healthcare Limited, is a radio-labelled tracer that binds to αvβ3 integrin, aiding in the visualization of endometriotic lesions. Preliminary trials show positive efficacy and tolerance.
- The ongoing DETECT trial, set to complete primary data collection by September 2024, is investigating the efficacy of 99mTc-maraciclatide in diagnosing endometriosis. The trial's findings will compare SPECT-CT scan results with laparoscopic findings for diagnostic accuracy.
Up to 1 in 10 reproductive-aged women are impacted by endometriosis, which presents as tissue similar to the lining of the uterus appearing outside the uterus. Women with endometriosis may experience significant pain and infertility, but varying symptoms make diagnosis difficult.
Endometriosis has also been associated with increased risks of mental health conditions.2 In one study, 67% of patients with endometriosis were diagnosed with a mental health condition vs 51.2% without endometriosis. A severe mental health condition was reported in 7% vs 4.6%, respectively, and medically diagnosed patients had the highest risk of self-harm.
SPE is the earliest form of endometriosis and makes up approximately 80% of diagnoses.1 Current magnetic resonance imaging and ultrasound non-invasive tools used for diagnosis are unable to provide strong visualization, making laparoscopy necessary for a definitive diagnosis.
Serac Healthcare Limited developed 99mTc-maraciclatide, a radio-labelled tracer that images new blood vessel formation linked to the growth of endometriotic lesions. This is accomplished by binding with high affinity to the cell adhesion protein αvβ3 integrin. Trials have displayed positive efficacy and tolerance data from the use of 99mTc-maraciclatide.
Efficacy was identified in preliminary data from the Detecting Endometriosis expressed integrins using technetium-99m (DETECT) imaging study. DETECT is an ongoing phase 2 clinical trial investigating the presence of binding proteins in endometriotic tissue to improve understanding of endometriosis.3
Participants include women with endometriosis symptoms, presenting for an imaging scan 2 to 7 days before surgery. The imaging scan was performed with a molecular marker that has been able to identify integrins in other expressions.
The DETECT trial is ongoing, with primary completion planned for September 2024. Findings from SPECT-CT scans will be used to diagnose endometriosis and be compared to laparoscopic findings to determine efficacy. Additionally, a control sample of 25 women will provide endometrial tissue samples to compare integrin expression.
Following the preliminary data, the FDA granted Fast Track Designation to technetium-99m.1 The goal of a Fast Track Designation is to support the development and review of a drug that can help manage or diagnosis severe conditions in patients, providing a critical unmet medical need.
To receive a Fast Track Designation for diagnosis, a product must improve diagnosis of the condition, and early diagnosis should lead to improved outcomes. Products with a Fast Track Designation meeting relevant criteria are also eligible for Accelerated Approval and Priority Review.
The designation will also allow for more meetings with the FDA to facilitate a development plan for the drug and allow appropriate data collection. Serac Healthcare Limited will also have access to written communication with the FDA.
Finally, Rolling Review will allow the company to submit completed sections of its New Drug Application (NDA) rather than wait for every section of the NDA to be completed before reviewal. These benefits will help accelerate the development process and bring the product to US consumers sooner.
References
- 99mTc-maraciclatide granted FDA Fast Track Designation for the diagnosis of superficial peritoneal endometriosis. Serac Healthcare. July 2, 2024. Accessed July 2, 2024. https://www.serachealthcare.com/news-cpt/%e2%81%b9%e2%81%b9%e1%b5%90tc-maraciclatide-granted-fda-fast-track-designation-for-the-diagnosis-of-superficial-peritoneal-endometriosis/
- Krewson C. Endometriosis linked to higher risk of mental health conditions. June 18, 2024. Accessed July 2, 2024. https://www.contemporaryobgyn.net/view/endometriosis-linked-to-higher-risk-of-mental-health-conditions
- DETECT (Detecting Endometriosis inTEgrins Using teChneTium-99m Imaging Study). ClinicalTrials. June 14, 2024. Accessed July 2, 2024. https://clinicaltrials.gov/study/NCT05623332?intr=NC100692&rank=4
