• 64Cu-SARTATE detected substantially more lesions than standard-of-care 68Ga-DOTATATE
• 93.5% of discordant lesions were detected only by 64Cu-SARTATE
• 64Cu-SARTATE demonstrated high lesion-level sensitivity of 93.4% to 95.6%

Clarity Pharmaceuticals announced positive topline results from the DISCO Phase II trial, which compared the diagnostic performance of its 64Cu-SARTATE PET imaging agent to the standard-of-care 68Ga-DOTATATE in patients with known or suspected neuroendocrine tumours (NETs). The results showed that 64Cu-SARTATE substantially outperformed 68Ga-DOTATATE in lesion detection, identifying 393 to 488 lesions compared to 186 to 265 lesions detected by the standard agent. Out of all the discordant lesions identified, 93.5% were only detected by 64Cu-SARTATE. For the discordant lesions with available standard-of-truth data, 64Cu-SARTATE demonstrated a very high lesion-level sensitivity of 93.4% to 95.6%, compared to only 4.4% to 6.6% for 68Ga-DOTATATE. 64Cu-SARTATE was also found to be safe and well-tolerated, with only mild adverse events observed. Based on these positive results, Clarity will progress to a registrational Phase III study of 64Cu-SARTATE in NETs with guidance from the US FDA.

Clarity plans to rapidly progress discussions with the FDA to initiate a diagnostic registrational Phase III study of 64Cu-SARTATE in NETs, as a first step in expanding the product into the theranostic field for NETs and other SSTR2-expressing cancers.