• Clarity receives US FDA Fast Track Designation for 67Cu-SAR-bisPSMA in mCRPC
• Positive preliminary results from Phase I/IIa SECuRE trial, with PSA reductions in 73% of participants
• Cohort expansion to assess 67Cu-SAR-bisPSMA in combination with enzalutamide

Clarity Pharmaceuticals (ASX: CU6) announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for 67Cu-SAR-bisPSMA for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with androgen receptor pathway inhibition (ARPI). This milestone builds on Clarity's earlier receipt of 2 FTDs for the diagnostic 64Cu-SAR-bisPSMA. The preliminary results from the Phase I/IIa SECuRE trial showed that 73% of participants had reductions in prostate-specific antigen (PSA) levels, with 45% achieving PSA reductions of greater than 50%. The trial is progressing through the highest dose cohort, with a participant in cohort 4 experiencing a 98% decline in PSA and a 60.6% reduction in tumour volume. Clarity has also amended the SECuRE trial protocol to increase the cohort expansion phase from 14 to 24 participants, with a subset to receive the combination of 67Cu-SAR-bisPSMA and enzalutamide. The FTD will enable Clarity to accelerate the development of its comprehensive program with the optimised SAR-bisPSMA agent to be used in patients with prostate cancer throughout the management of their cancer.

The FTDs will allow Clarity to work closely with the FDA to facilitate the development process and accelerate the approval of what could become best-in-class therapy and diagnostic agents for prostate cancer.