How Clarity’s Cu-SAR-bisPSMA Is Changing Prostate Cancer Detection

• Co-PSMA trial meets primary endpoint with superior lesion detection
• Cu-SAR-bisPSMA outperforms Ga-PSMA-11 PET/CT in low PSA prostate cancer patients
• Findings build on positive COBRA and PROPELLER trial results
• Supports potential for earlier, more precise prostate cancer recurrence diagnosis
• Clarity advancing Phase III trials targeting FDA approval and commercialization

Clarity’s Breakthrough in Prostate Cancer Imaging

Clarity Pharmaceuticals (ASX, CU6) has announced a significant milestone in its clinical development program with the Co-PSMA Phase II Investigator-Initiated Trial (IIT) achieving its primary endpoint. The trial, led by Professor Louise Emmett at St Vincent’s Hospital Sydney, demonstrated that Clarity’s novel diagnostic agent, Cu-SAR-bisPSMA, detects a statistically higher number of prostate cancer lesions compared to the current standard-of-care (SOC) imaging agent Ga-PSMA-11 PET/CT in patients with low prostate-specific antigen (PSA) levels.

This result is particularly important for men with biochemical recurrence of prostate cancer following radical prostatectomy, where early and accurate detection of recurrent lesions can guide curative salvage therapy. The Co-PSMA trial enrolled 50 patients with PSA levels between 0.2 and 0.75 ng/mL, a range where existing imaging agents often struggle with sensitivity.

Building on a Strong Clinical Foundation

The Co-PSMA findings reinforce earlier positive data from Clarity’s COBRA and PROPELLER trials. The COBRA trial notably showed Cu-SAR-bisPSMA identified lesions up to six months earlier than SOC agents, with a higher lesion count on both same-day and next-day imaging. PROPELLER data further highlighted improved tumour uptake and tumour-to-background ratios, critical factors for detecting small lesions that standard agents frequently miss.

These cumulative results suggest Cu-SAR-bisPSMA could redefine the diagnostic landscape for prostate cancer by offering enhanced sensitivity and earlier detection, potentially improving patient outcomes through more informed treatment decisions.

Commercial and Clinical Implications

Dr Alan Taylor, Clarity’s Executive Chairperson, emphasised the strategic importance of these results, noting the potential for Cu-SAR-bisPSMA to become the new standard-of-care in PSMA PET imaging. With the US market for PSMA PET imaging currently valued at around US$2 billion and expected to exceed US$3 billion by 2029, Clarity’s agent could not only capture market share but also expand the market by enabling earlier diagnosis when lesions are smaller and more treatable.

Clarity is now focused on advancing Cu-SAR-bisPSMA through pivotal Phase III trials, CLARIFY and AMPLIFY, aiming for regulatory approval by the US Food and Drug Administration (FDA). The company’s proprietary SAR technology, which securely holds copper isotopes to prevent leakage, underpins both diagnostic and therapeutic applications, positioning Clarity at the forefront of targeted copper theranostics.

Looking Ahead

Full data from the Co-PSMA trial will be presented at upcoming international conferences, providing the medical community and investors with deeper insights into Cu-SAR-bisPSMA’s clinical performance. As Clarity continues to collaborate with leading experts like Prof Emmett, the company is well placed to deliver a best-in-class diagnostic tool that could transform prostate cancer management.

Bottom Line?

Clarity’s Cu-SAR-bisPSMA is poised to challenge the status quo in prostate cancer imaging, with upcoming data and regulatory milestones set to shape its market trajectory.

Questions in the middle?

• How will regulatory authorities respond to Cu-SAR-bisPSMA’s clinical data in upcoming submissions?
• What are the timelines and commercial strategies for Cu-SAR-bisPSMA’s market launch?
• How might competitors react to Clarity’s emerging diagnostic advantage in PSMA PET imaging?