First patient imaged in Phase III AMPLIFY trial

• First patient imaged in registrational Phase III AMPLIFY trial for 64Cu-SAR-bisPSMA PET/CT
• 64Cu-SAR-bisPSMA could become a best-in-class diagnostic PSMA agent
• Trial aims to gather data for NDA and potential commercialisation

Clarity Pharmaceuticals has imaged the first patient in its registrational Phase III AMPLIFY trial for 64Cu-SAR-bisPSMA PET/CT, a diagnostic agent for prostate cancer. The trial will evaluate the ability of 64Cu-SAR-bisPSMA to detect recurrence of prostate cancer, with imaging at two timepoints. The study will enrol approximately 220 participants across the US and Australia, with the final results intended to support an FDA approval application for 64Cu-SAR-bisPSMA as a new diagnostic imaging agent in biochemical recurrence of prostate cancer. 64Cu-SAR-bisPSMA is a Targeted Copper Theranostic that can be used with copper-64 for imaging and copper-67 for therapy. Earlier trials have shown it can detect more lesions and identify them earlier than current standard-of-care PSMA PET agents. Clarity has built a robust supply chain for copper-64 to support the AMPLIFY and CLARIFY trials, as well as potential commercialisation. The company believes 64Cu-SAR-bisPSMA can overcome limitations of current PSMA PET diagnostics, enabling earlier and more accurate detection of recurrent prostate cancer.

Clarity is focused on progressing the AMPLIFY trial, opening clinical sites in the US and Australia, and building towards potential commercialisation of 64Cu-SAR-bisPSMA as a best-in-class diagnostic PSMA agent for prostate cancer.