Clinical-stage radiopharmaceutical company Clarity Pharmaceuticals has announced positive top-line results from its Phase II DISCO trial, demonstrating that its 64Cu-SARTATE imaging agent significantly outperformed the current standard of care in detecting lesions in patients with neuroendocrine tumors (NETs).
Superior Lesion Detection Performance
The DISCO study, which recruited 45 participants with gastroenteropancreatic NETs across four Australian sites, revealed substantial improvements in diagnostic capability. 64Cu-SARTATE detected between 393 to 488 lesions, while the standard 68Ga-DOTATATE imaging identified only 186 to 265 lesions among the same patient population across multiple readers.
The trial compared the diagnostic performance of 64Cu-SARTATE PET imaging at an average of 4 hours and approximately 20 hours post-administration to the current standard of care. Participants received 200 MBq of 64Cu-SARTATE and were required to have undergone a pre-study 68Ga-DOTATATE PET/CT scan within 5 weeks as part of their routine clinical care.
Study Design and Methodology
Originally designed to enroll up to 63 patients based on anticipated lesion-level discordance rates between the two imaging agents, the study sample size was adjusted to 45 patients following a pre-planned early analysis. This adjustment allowed for earlier enrollment completion while maintaining statistical validity.
"We are very excited about the initial topline data from the DISCO trial as 64Cu-SARTATE was confirmed to be safe and very effective in detecting NET lesions in patients with known or suspected disease," said Dr. Alan Taylor, Clarity's executive chairperson. "The DISCO trial demonstrates a significant advantage of our diagnostic over 68Ga-DOTATATE."
Regulatory and Commercial Implications
The positive results have prompted Clarity to accelerate its regulatory pathway discussions. The company plans to rapidly progress discussions with the FDA to initiate a diagnostic registrational Phase III study, representing a crucial step in expanding SARTATE into the theranostic field for NETs and other SSTR2-expressing cancers using the copper-64/copper-67 pair.
Dr. Taylor emphasized the potential clinical impact: "If the findings from the DISCO trial are substantiated in a registrational Phase III study and lead to regulatory approval by the US FDA, 64Cu-SARTATE may play an important role in improving diagnostic accuracy, lesion detection and staging of patients with NETs. These factors could improve clinical decision-making and treatment outcomes, potentially positioning 64Cu-SARTATE as a best-in-class agent for the diagnosis of NETs."
Market Position and Future Outlook
The results position Clarity Pharmaceuticals favorably within the radiopharmaceutical industry, particularly in the growing theranostic market. The company, listed on the Australian Securities Exchange under ticker CU6 with a current market capitalization of A$609 million, has received analyst coverage with a Buy rating and A$7.40 price target.
Clarity plans to present additional data readouts from the trial at future international medical conferences, providing further validation of the technology's clinical utility in NET diagnosis and management.
