Clarity Pharmaceuticals reports another metastatic prostate cancer patient achieving undetectable disease markers in its Phase II SECuRE trial, reinforcing promising efficacy and safety of its Cu-SAR-bisPSMA radiopharmaceutical.
- Fifth patient with undetectable PSA and negative PSMA PET after Cu-SAR-bisPSMA treatment
- Participant achieved undetectable PSA after first cycle and negative PET after second cycle
- Treatment well tolerated with only mild, mostly resolved adverse events
- Ongoing recruitment in Phase II with Phase III registrational trial planning underway
- Three FDA Fast Track Designations support regulatory progress
Another Milestone in Prostate Cancer Treatment
Clarity Pharmaceuticals has announced a significant development in its ongoing SECuRE trial, with a fifth participant diagnosed with metastatic castration-resistant prostate cancer (mCRPC) achieving undetectable disease markers. The patient, a 76-year-old man with a 15-year history of prostate cancer, showed undetectable prostate-specific antigen (PSA) levels just seven weeks after the first cycle of Cu-SAR-bisPSMA treatment, followed by a negative prostate-specific membrane antigen (PSMA) PET scan after the second cycle.
This outcome adds to the mounting evidence supporting the efficacy of Clarity’s lead radiopharmaceutical, Cu-SAR-bisPSMA, which combines targeted copper isotopes with a proprietary chelating technology designed to improve both imaging and therapeutic outcomes. The trial’s Phase II Cohort Expansion continues to enrol patients, aiming to validate these encouraging results in a larger population.
Safety and Sustained Efficacy
The treatment was well tolerated, with only mild (Grade 1) adverse events reported, such as altered taste and fatigue, most of which resolved quickly. Importantly, no haematological or renal toxicities have been observed, underscoring the favourable safety profile of Cu-SAR-bisPSMA. This aligns with previous trial data where participants experienced significant PSA reductions and sustained undetectable disease status, including a patient who remains disease-free after four treatment cycles.
Clarity’s Executive Chairperson, Dr Alan Taylor, highlighted the significance of these findings, noting that the consistency of undetectable disease across multiple patients dispels any notion of coincidence. He emphasised the unique advantages of the SAR technology platform, which securely holds copper isotopes to enhance both diagnostic precision and therapeutic impact.
Looking Ahead: Phase III and Commercial Prospects
With recruitment ongoing and plans for a registrational Phase III trial already underway, Clarity is positioning Cu-SAR-bisPSMA for potential commercialisation. The company’s diagnostic trials, AMPLIFY and CLARIFY, are also nearing completion, further supporting the product’s market readiness. Notably, Cu-SAR-bisPSMA has received three Fast Track Designations from the US FDA, reflecting regulatory confidence in its potential to address unmet needs in prostate cancer management.
Prostate cancer remains a leading cause of cancer mortality among men worldwide, and innovations like Cu-SAR-bisPSMA could transform the treatment landscape by offering targeted, effective options with manageable side effects. Clarity’s methodical clinical development approach and strong data momentum suggest the company is on a promising trajectory to deliver meaningful advances for patients.
Bottom Line?
As Clarity advances toward Phase III, the radiopharmaceutical’s consistent patient responses hint at a potential new standard in prostate cancer care.
Questions in the middle?
- Will the Phase III trial confirm these early efficacy and safety results in a larger, more diverse patient population?
- How will Cu-SAR-bisPSMA compare in cost and accessibility to existing prostate cancer treatments if approved?
- What are the long-term outcomes and quality of life impacts for patients treated with Cu-SAR-bisPSMA?