Clarity Pharma Co-PSMA Trial Meets Main Goal, Detects More Prostate Cancer Lesions Than Standard One

(RTTNews) - Clarity Pharmaceuticals (CU6.AX), a clinical-stage radiopharmaceutical company, announced that its Co-PSMA (NCT06907641) Investigator-Initiated Trial (IIT), led by Prof. Louise Emmett at St Vincent's Hospital, Sydney, has met its primary goal.

The study showed that 64Cu-SAR-bisPSMA detected significantly more PSMA-positive prostate cancer lesions than the standard 68Ga-PSMA-11 PET/CT in patients with low PSA levels.

The Phase II IIT is evaluating the performance of Clarity's diagnostic product, 64Cu-SAR-bisPSMA, in comparison to SOC 68Ga-PSMA-11 in 50 patients with low PSA who are candidates for curative salvage therapy. Eligible patients were required to have had a radical prostatectomy with no salvage therapy and a PSA level between 0.2 and 0.75 ng/mL.

The Co-PSMA trial has successfully met its primary endpoint, demonstrating that 64Cu-SAR-bisPSMA PET/CT detects significantly more lesions per patient than the SOC, 68Ga-PSMA-11 PET/CT.

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.

Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, commented: "Achieving the primary endpoint in the Co-PSMA trial, which was a head-to-head trial against a SOC competing product, is yet another important step in the development of 64Cu-SAR-bisPSMA as we look to further validate this agent as best-in-class through two registrational trials with two Fast Track Designations (FTDs) under our belt for diagnostic applications and a strong focus on commercialisation."