#Australia #Sydney #Clarity Pharmaceuticals #64Cu-SAR-bisPSMA #Co-PSMA Trial

Clarity Pharmaceuticals Achieves Milestone in Prostate Cancer Detection

Clarity Pharmaceuticals, a clinical-stage radiopharmaceutical company based in Sydney, has reported a significant breakthrough in the early detection of prostate cancer through its recent trial of 64Cu-SAR-bisPSMA. The Co-PSMA trial, led by Professor Louise Emmett at St Vincent's Hospital, has achieved its primary endpoint. The trial's outcomes indicate that the innovative imaging agent detected a higher number of prostate-specific membrane antigen (PSMA)-positive lesions when compared to the current standard of care (SOC) 68Ga-PSMA-11 positron emission tomography/computed tomography (PET/CT).

This phase II investigator-initiated trial aimed to evaluate how effectively 64Cu-SAR-bisPSMA could detect prostate cancer recurrence in patients with low PSA levels after a radical prostatectomy. Among the 50 patients involved in the study, those receiving the 64Cu-SAR-bisPSMA scan showcased significantly higher lesion detection rates than those who underwent the SOC procedure. This advancement points towards the potential for improved outcomes in early prostate cancer diagnosis and subsequent treatment.

The formal study title is "Comparative performance of 64Copper [64Cu]-SAR-bisPSMA vs. 68Ga-PSMA-11 PET CT for the detection of prostate cancer recurrence in the setting of biochemical failure following radical prostatectomy." Eligible patients were those who had undergone radical prostatectomy with PSA levels ranging from 0.2 to 0.75 ng/mL and had not previously received salvage therapy.

The encouraging results from the Co-PSMA trial are indicative of a broader trend noted in Clarity Pharmaceuticals' previous COBRA trial. In the COBRA study, which focused on patients exhibiting biochemical recurrence of prostate cancer, the findings showed a superior diagnostic performance of 64Cu-SAR-bisPSMA in comparison to SOC imaging techniques. Notably, on same-day imaging, 70% of participants exhibited positive results with 64Cu-SAR-bisPSMA versus only 60% for the SOC. Even more compelling was the next-day imaging result, where 90% detected lesions with 64Cu-SAR-bisPSMA.

These series of trials not only highlight the enhanced capability of 64Cu-SAR-bisPSMA in identifying prostate cancer but also emphasize the remaining shortfall of current SOC PET agents, which often struggle in sensitivity and accuracy, particularly at lower PSA levels. By improving early detection, the implications for treatment decisions and patient outcomes could be profound and transformative.

Dr. Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, spoke about the significance of reaching this trial's primary endpoint. He stated, "This result underscores the strength of 64Cu-SAR-bisPSMA as a potential industry standard for prostate cancer detection. Our progress in this area, combined with our commitment to rigorous clinical research, reflects our aim to provide better diagnostic options for affected men."

As Clarity Pharmaceuticals continues its journey toward commercializing 64Cu-SAR-bisPSMA, the company is gearing up for further validation through upcoming registrational trials. With two Fast Track Designations already awarded for this innovative diagnostic application, the attention is squarely on presenting the full dataset from the Co-PSMA trial to the medical community.

The current market for PSMA PET imaging in the United States is approximately $2 billion per year, with expectations for growth to surpass $3 billion by 2029. Yet, existing products lack differentiation and exhibit low sensitivity, presenting a significant opportunity for Clarity Pharmaceuticals to introduce 64Cu-SAR-bisPSMA as a new standard of care in prostate cancer imaging.

The innovative SAR-bisPSMA technology employs a unique combination of PSMA-targeting agents and relies on proprietary sarcophagine technology to secure copper isotopes. This mechanism not only enhances diagnostic capabilities but also ensures safety through reduced leakage of copper into the body.

As the world’s second most common cancer in men, prostate cancer remains a pressing health issue. In 2025 alone, the American Cancer Institute estimates there will be approximately 313,780 new cases of prostate cancer in the U.S., signifying an urgent need for improved detection methods such as 64Cu-SAR-bisPSMA.

Looking forward, Clarity Pharmaceuticals aims to solidify its position as a leader in radiopharmaceutical innovation, supporting enhanced treatment outcomes in prostate cancer care through cutting-edge technology and research.