• First patient safely dosed in the pivotal Phase III ⁶⁴Cu-SAR-bisPSMA diagnostic trial, CLARIFY.
• The aim of the CLARIFY trial is to detect regional nodal metastases in participants with prostate cancer prior to radical prostatectomy.
• Final results from the CLARIFY trial are intended to provide sufficient evidence to support an application to the FDA for the approval of the ⁶⁴Cu-SAR-bisPSMA product in pre-prostatectomy patients.

The aim of the CLARIFY study is to assess the diagnostic performance of ⁶⁴Cu-SAR-bisPSMA to detect regional nodal metastases in participants with high-risk prostate cancer prior to radical prostatectomy. The study will recruit 383 participants at multiple clinical sites across the United States and Australia.

Evaluation of the first patient is taking place over 2 imaging timepoints, day 1 (day of administration) and day 2 (approximately 24 hours post administration) and the patient will be followed up as per protocol. Subsequent patients will be evaluated in the same manner. As a pivotal trial, the final study results are intended to provide sufficient evidence to support an application to the FDA for approval of ⁶⁴Cu-SAR-bisPSMA as a new diagnostic imaging agent in prostate cancer in pre-prostatectomy patients.

Clarity's Executive Chairperson, Dr Alan Taylor, commented, "We are excited to have successfully dosed the first participant in the CLARIFY trial with our optimised SAR-bisPSMA agent. The trial is driven by the compelling findings from our PROPELLER trial (NCT04839367)^2,3 which highlighted the robust safety profile and superior performance of ⁶⁴Cu-SAR-bisPSMA compared to standard of care imaging (⁶⁸Ga-PSMA-11) with imaging on the day of administration, with two to three times the amount of product taken up in the lesions^2,3. The longer half-life of copper-64 based diagnostics, in comparison to the currently used gallium-68 and fluorine-18 based products, also allows for delayed imaging. These unique features have the potential to enable detection of additional lesions compared to standard of care imaging and may address the significant shortfall in sensitivity of these agents. Additionally, the extended shelf-life of ⁶⁴Cu-SAR-bisPSMA of up to 48 hours, in contrast to the short shelf-life of currently available PSMA PET tracers, not only enhances scheduling flexibility for clinics, but also addresses a critical need for diagnostics in geographic areas with limited access to the current generation of radiopharmaceuticals.

"Clarity is steadfast in addressing the high unmet need for diagnostics and therapies in the prostate cancer domain. Our optimism is rooted in the belief that our SAR-bisPSMA product can redefine diagnostic standards and improve patient outcomes. As we progress with the CLARIFY trial, we anticipate validating and building upon the positive data accumulated so far. Our vision is a future where enhanced diagnostic tools empower clinicians to make more informed decisions, ultimately shaping the optimal course of treatment for their patients.

"Although the current generation of PSMA-based radiopharmaceuticals is broadening the horizons of prostate cancer management and offering new treatment pathways for patients in need, we have seen in Clarity's PROPELLER trial that ⁶⁴Cu-SAR-bisPSMA has the potential of really changing this paradigm and outcomes for patients. We look forward to exploring and confirming these benefits in the CLARIFY trial."