Co-PSMA trial achieves primary endpoint
| Stock | Clarity Pharmaceuticals Ltd (CU6.ASX) |
|---|---|
| Release Time | 14 Oct 2025, 9:26 a.m. |
| Price Sensitive | Yes |
Co-PSMA trial achieves primary endpoint
- Co-PSMA trial demonstrates 64Cu-SAR-bisPSMA detects significantly more lesions per patient than standard-of-care 68Ga-PSMA-11 PET/CT
- Results support the hypothesis that 64Cu-SAR-bisPSMA can improve early detection of recurrence and staging of prostate cancer in patients with low PSA
- Findings corroborate results from the COBRA trial, which showed 64Cu-SAR-bisPSMA identified lesions more than 6 months earlier than standard-of-care PSMA PET agents
Clarity Pharmaceuticals has announced that the Co-PSMA Investigator-Initiated Trial, led by Prof Louise Emmett at St Vincent's Hospital Sydney, has achieved its primary endpoint. The trial demonstrated that 64Cu-SAR-bisPSMA PET/CT detects significantly more lesions per patient than the standard-of-care 68Ga-PSMA-11 PET/CT in patients with low PSA levels. This result supports the hypothesis that 64Cu-SAR-bisPSMA can improve early detection of recurrence and staging of prostate cancer in patients with low PSA who are candidates for curative salvage therapy. The Co-PSMA topline results corroborate findings from the COBRA trial, which showed that 64Cu-SAR-bisPSMA was able to identify lesions more than 6 months earlier than standard-of-care PSMA PET agents. The improvements in sensitivity offered by 64Cu-SAR-bisPSMA compared to existing PSMA PET agents, which are known to have low sensitivity, especially in patients with low PSA levels, can play a pivotal role in guiding more informed treatment decisions, enabling earlier and more accurate detection of prostate cancer recurrence and ultimately improving patient outcomes. Clarity Pharmaceuticals is focused on continuing to generate high-quality data to support its New Drug Applications to the US FDA as it progresses the clinical development of 64Cu-SAR-bisPSMA, including its CLARIFY and AMPLIFY Phase III trials.
Clarity Pharmaceuticals believes that with the clinical and logistical benefits offered by 64Cu-SAR-bisPSMA, the company could not only become the new standard-of-care in PSMA PET but also grow the market opportunity further by diagnosing prostate cancer earlier, while lesions are still very small.