Clarity Pharmaceuticals Accelerates Prostate Cancer Imaging with FDA Fast Track Nod

FDA Fast Track Designation Boosts Clarity’s Prostate Cancer Imaging Ambitions

Clarity Pharmaceuticals (ASX: CU6) has achieved a significant regulatory milestone with the U.S. Food and Drug Administration granting a second Fast Track Designation (FTD) for its novel radiopharmaceutical, 64Cu-SAR-bisPSMA. This designation targets patients experiencing biochemical recurrence (BCR) of prostate cancer, a critical phase where early and accurate detection can dramatically influence treatment outcomes.

The Fast Track status is designed to expedite the development and review process for drugs addressing serious conditions with unmet medical needs. For Clarity, this means accelerated regulatory interactions, the ability to submit portions of their approval application as they are completed, and ultimately a faster path to market. This complements an earlier FTD granted for the same agent in patients with suspected metastasis prior to initial definitive therapy, positioning 64Cu-SAR-bisPSMA as a comprehensive diagnostic tool across multiple prostate cancer stages.

Technological Edge Over Current PSMA PET Agents

64Cu-SAR-bisPSMA distinguishes itself through its bivalent bisPSMA structure and the use of copper-64, which has a notably longer half-life (12.7 hours) compared to the fluorine-18 and gallium-68 isotopes (<2 hours) used in existing PSMA PET agents. This allows for flexible imaging schedules, including next-day scans, which have demonstrated superior lesion detection capabilities.

Data from the Phase I/II COBRA study revealed that next-day imaging with 64Cu-SAR-bisPSMA localized disease in up to 80% of participants, detecting lesions as small as 2 mm, significantly smaller than the 5 mm detection limit typical of current standard-of-care agents. The ability to identify more lesions earlier could translate into more precise treatment planning and improved patient outcomes.

Pivotal Trials and Market Potential

Building on COBRA’s promising results, Clarity is preparing to launch the AMPLIFY Phase III trial, a non-randomized, multi-center study involving approximately 220 patients with rising PSA levels after initial treatment. The trial’s outcome is expected to form the cornerstone of Clarity’s FDA approval application.

Additionally, the investigator-initiated Co-PSMA trial at St Vincent’s Hospital Sydney will compare 64Cu-SAR-bisPSMA directly with the current standard 68Ga-PSMA-11, further validating its diagnostic superiority.

Dr Alan Taylor, Clarity’s Executive Chairperson, highlighted the market opportunity, noting the current US prostate cancer diagnostic market is valued at around US$2 billion and projected to grow to US$3 billion by 2029. He emphasized that 64Cu-SAR-bisPSMA’s unique features and improved diagnostic performance could disrupt a market currently dominated by undifferentiated products.

Innovative SAR Technology and Broader Implications

At the core of Clarity’s innovation is its proprietary SAR (sarcophagine) chelator technology, which securely binds copper isotopes, preventing leakage and enhancing safety. This technology underpins the theranostic potential of SAR-bisPSMA, which can be paired with copper-64 for imaging and copper-67 for therapeutic applications.

The longer half-life of copper-64 also facilitates centralized manufacturing and wider distribution, potentially reducing geographic disparities in access to advanced prostate cancer diagnostics.

While 64Cu-SAR-bisPSMA remains unregistered and its commercial availability is not guaranteed, the FDA’s Fast Track Designation signals strong confidence in its potential to address critical gaps in prostate cancer care.