Clarity Pharmaceuticals (ASX: CU6), a clinical-stage radiopharmaceutical company focused on the treatment of serious diseases, has announced its Cu-64 SAR-bisPSMA product received Breakthrough Therapy designation from the United States Food and Drug Administration (FDA). The Company is a leader in innovative radiopharmaceuticals, developing Targeted Copper Theranostics based on its SAR Technology Platform for the treatment of cancers. This designation applies to positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected recurrence based on elevated serum prostate-specific antigen (PSA). Breakthrough Therapy status aims to expedite development and review for serious conditions, offering intensive FDA guidance and a collaborative review process, which signals potential for substantial improvement over existing therapies.
The FDA’s decision was supported by robust data from Clarity’s Phase II Co-PSMA and Phase I/II COBRA trials, alongside real-world evidence. This collective data indicates enhanced diagnostic performance of Cu-64 SAR-bisPSMA compared to existing standard-of-care (SOC) PSMA PET in detecting recurrent prostate cancer. Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, noted the significance, highlighting that fewer than half of such designation requests are successful. He emphasised this status addresses an unmet need for more accurate detection of recurrent prostate cancer lesions and acknowledges the superior diagnostic capabilities of Cu-64 SAR-bisPSMA.
Dr Taylor further elaborated that current FDA-approved PSMA PET agents often miss metastatic disease, particularly in patients with small volume disease or lower PSA levels. In contrast, Co-PSMA trial data showed Cu-64 SAR-bisPSMA achieved a 78% detection rate, more than double the 36% observed with 68Ga-PSMA-11 in a comparable patient group (median PSA 0.43 ng/mL). Clarity is progressing two registrational Phase III trials, AMPLIFY and CLARIFY, both having completed recruitment. Topline data from these pivotal trials, aimed at supporting US FDA approval, are anticipated in the first half of calendar year 2027.
