• Topline data showed 64Cu-SAR-Bombesin was safe, well tolerated and effective at detecting prostate cancer in patients with biochemical recurrence and negative/equivocal standard-of-care scans
• 64Cu-SAR-Bombesin identified lesions in up to 43% of participants, highlighting the potential to address a significant diagnostic gap
• All biopsied lesions positive for prostate cancer, indicating a 100% true-positive rate among those biopsied

Clarity Pharmaceuticals announced positive topline results from the SABRE trial, a diagnostic Phase II trial evaluating the safety and efficacy of 64Cu-SAR-Bombesin PET imaging in patients with biochemical recurrence of prostate cancer and negative or equivocal standard-of-care scans. The trial enrolled 53 patients, with approximately 47 evaluable for the primary endpoints. The average detection rate across readers using 64Cu-SAR-Bombesin PET/CT was 35.2% on same-day imaging and 27.7% on next-day imaging, identifying a total of around 49 lesions. The participant-level correct detection rate was 14.9% on same-day imaging and up to 14.9% on next-day imaging, while region-level positive predictive value ranged from 22.6% to 47.1% on same-day and 22.2% to 37.5% on next-day imaging. Although biopsy was not feasible for most lesions, all biopsied lesions were confirmed positive for prostate cancer. The agent was shown to be safe and well-tolerated, with only two participants experiencing mild, transient adverse events. These results highlight the potential of 64Cu-SAR-Bombesin to address a significant diagnostic gap, as some patients with prostate cancer recurrence may lack PSMA expression and remain undetectable on standard PSMA-targeted imaging.

Clarity has commenced discussions with medical experts to determine the most effective pathway for registration of 64Cu-SAR-Bombesin and to explore its development in a range of large oncology indications with high unmet needs.