공시 • Mar 18
Clarity Pharmaceuticals Ltd Presents Co-PSMA Trial Data And Announces Acceptance For Publication In European Urology
Clarity Pharmaceuticals announced that the results from the Co-PSMA (NCT06907641) IIT were presented by Prof Louise Emmett (St Vincent's Hospital Sydney) in an oral session at EAU Congress 2026, Europe's largest urological conference, on the 16 March in London, UK. The study data has also been accepted for publication in European Urology, the official journal of EAU with an impact factor of 25.2. Co-PSMA (Comparative performance of Copper [Cu]-SAR-bisPSMA vs. Ga-PSMA-11 PET CT for the detection of prostate cancer recurrence in the setting of biochemical failure following radical prostatectomy) was a Phase II IIT evaluating the performance of Clarity's diagnostic product, Cu-SAR-bisPSMA, in a head-to-head comparison to SOC Ga-PSMA-11 in 50 patients with low PSA (0.2 – 0.75 ng/mL) who were candidates for curative salvage therapy. Eligible patients were required to have had radical prostatectomy with no salvage therapy. Ga-PSMA-11 PET/CT was followed by Cu-SAR-bisPSMA PET/CT (at 1 hour and 24 hours post-injection, same-day and next-day imaging, respectively) on the same digital PET camera. The primary endpoint of the Co-PSMA study was to assess the difference in mean per patient lesion number. Using a paired means test, a sample size of 50 provided power of 90% to detect a minimum alternative mean difference greater than zero of 0.432. Secondary endpoints included management impact questionnaires between Cu-SAR-bisPSMA and Ga-PSMA-11 and accuracy of the PET findings determined using a comprehensive reference standard, including biopsy, response to targeted treatment without androgen deprivation therapy (ADT), PSA rise without treatment or corroborative imaging. Overall, Cu-SAR-bisPSMA PET/CT (24-hour imaging) was found to identify a higher number of disease recurrences than Ga-PSMA-11 PET/CT with substantial management impact and a high true positive rate in men with BCR post-radical prostatectomy. Participants enrolled had a median PSA of 0.43 (IQR: 0.31 – 0.63) and 74% had an International Society of Urological Pathologists (ISUP) grade of 3 or higher. The mean per-patient lesion for Cu-SAR-bisPSMA (24-hour imaging) was 1.26, compared to 0.48 for Ga-PSMA-11, with a difference of 0.78 (95%CI: 0.52 – 1.04), ratio 2.63 (95%CI: 1.64 – 4.20) (p <0.0001). In total, Ga-PSMA-11 identified 24 lesions across all participants, while 24-hour Cu-SAR-bisPSMA imaging detected 63 lesions. The increase in the number of lesions identified by Cu-SAR-bisPSMA was noted in the prostatic bed region (local recurrence), pelvic/extra-pelvic lymph nodes and bone. 24-hour Cu-SAR-bisPSMA scans resulted in a higher number of lesions detected and prostate-specific membrane antigen (PSMA) PET-positive participants as compared to Ga-PSMA-11 scans. On a per patient level, 36% (18/50) of participants were positive on Ga-PSMA-11 PET/CT, compared to 78% (39/50) on Cu-SAR-bisPSMA PET/CT (next-day imaging). Planned patient management changed following the assessment of the Cu-SAR-bisPSMA scans in 22/50 (44%) trial participants. Among the participants with an evaluable standard of truth (SOT), the true positive rate was 71% for 24-hour Cu-SAR-bisPSMA (24/34) compared to 29% (10/34) for Ga-PSMA-11. The false negative rate was 21% for 24-hour Cu-SAR-bisPSMA (7/34) vs. 65% for Ga-PSMA-11 (22/34). These results from the Co-PSMA IIT further build on the growing body of evidence demonstrating that Cu-SAR-bisPSMA improves the detection of prostate cancer compared to the current SOC PSMA PET agents which have lower sensitivity in patients with low PSA levels. In the Phase II COBRA trial, Cu-SAR-bisPSMA was evaluated in patients with BCR who had a negative or equivocal scan at study entry. Among participants with a follow-up SOC PSMA PET, 90% were positive on 24-hour Cu-SAR-bisPSMA PET compared with only 60% on SOC PSMA PET. Overall, next-day imaging with Cu-SAR-bisPSMA identified more than 2.6 times lesions than SOC PSMA PET. The COBRA data, combined with the Co-PSMA IIT results, will complement the anticipated findings from the Phase III registrational trial, AMPLIFY, which recently reached its target number of participants. Together, they are intended to be submitted to the US FDA for a market authorisation of Cu-SAR-bisPSMA in patients with BCR of prostate cancer. The high quality of these data now adds to the substantial body of evidence supporting the product, the optimised SAR-bisPSMA. The discovery and pre-clinical work has been previously circulated in numerous journals, including publications by long-term collaborator, Prof Paul Donnelly, sharing his seminal work on the sarcophagine (SAR) chelator as well as on the SARTATE, SAR-Bombesin and the optimised SAR-bisPSMA agents in 2023 in Chemical Reviews, one of the highest impact factor journals in chemistry with a 5-year impact factor of 67.5. The extraordinary quality of the academic research is coupled with the feverish pace of commercialisation where the registrational Phase III trials, AMPLIFY and CLARIFY, are nearing completion. AMPLIFY reached its target number of participants with rising or detectable PSA after initial definitive treatment at clinical sites across the US and Australia in just 9 months since imaging the first patient, and the company looks forward to collecting and analysing the final study data. Combined with results from the Co-PSMA and COBRA trials, it is believed it will constitute a compelling application for approval of Cu-SAR-bisPSMA by regulatory authorities for the BCR indication. Armed with three Fast Track Designations for the one SAR-bisPSMA agent, the company is ready to work closely with the US FDA to get it to patients in need as soon as possible, and will continue updating the market on the progress of the bisPSMA program, including significant milestones in the AMPLIFY, CLARIFY and SECuRE trials, as well as on the supply chain and regulatory developments as the company enters the market with its first product. SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity's proprietary SAR technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic that can be used with isotopes of copper-64 (Cu-64 or Cu) for imaging and copper-67 (Cu-67 or Cu) for therapy. Cu-SAR-bisPSMA and Cu-SAR-bisPSMA are unregistered products. Their safety and efficacy have not been assessed by health authorities such as the US FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that this product will become commercially available.
