SYDNEY, 22 August 2024 /PRNewswire/ — Clarity Pharmaceuticals (ASX: CU6) (“Clarity”), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for ⁶⁴Cu-SAR-bisPSMA for positron emission tomography (PET) imaging of prostate cancer lesions with positive prostate cancer behavior and suspected metastasis that are candidates for first definitive therapy.

The FDA’s Fast Track designation is intended to accelerate the development and regulatory approval of new drugs for serious diseases with significant unmet medical needs. ⁶⁴Cu-SAR-bisPSMA offers a number of benefits for product development. The designation paves the way for a potentially faster review process once Clarity submits its product approval application. In addition, it allows for more frequent communication with the FDA so that questions can be quickly resolved during development. In addition, Clarity can submit complete sections of its application as soon as they are ready, rather than waiting for the entire package to be ready before it can be submitted to the FDA. These benefits would shorten the review time required to bring this innovative prostate cancer imaging agent to market and potentially improve diagnosis and treatment planning for patients sooner.

Clarity’s Executive Chairman, Dr. Alan Taylorcommented: “Receiving the Fast Track designation for ⁶⁴Cu-SAR-bisPSMA is a significant milestone, particularly as we are actively recruiting for our first Phase III registration trial, CLARIFY, and preparing for an end-of-phase meeting with the FDA for a second pivotal Phase III trial of this product. The approval allows us to work closely with the FDA to facilitate the development process and potentially accelerate approval of this first-in-class diagnostic.”

Clarity’s ongoing clinical program with ⁶⁴Cu-SAR-bisPSMA includes studies in two indications: patients with prostate cancer before radical prostatectomy and with biochemical recurrence (BCR) of their disease. The completed Phase I PROPELLER study showed favorable results in terms of safety and efficacy in patients with prostate cancer before radical prostatectomy. Based on the convincing results of the PROPELLER study, Clarity started a Phase III registration study in this patient group, CLARIFY, for which recruitment is still ongoing. In parallel, the Phase I/II COBRA study is running. ⁶⁴Cu-SAR-bisPSMA was shown to be safe and highly effective in detecting prostate cancer lesions in patients with BCR. Based on the results of the COBRA study, Clarity began planning a second Phase III imaging study for approval. The Fast Track status is supported by the first clinical evidence suggesting that ⁶⁴Cu-SAR-bisPSMA may offer improved lesion detection compared to existing prostate cancer diagnostics.

“We believe that ⁶⁴Cu-SAR-bisPSMA could fundamentally change the way prostate cancer is diagnosed. Due to its dual targeting structure, BisPSMA, and the longer half-life of copper-64, which enables next-day imaging, this unique product has demonstrated higher tumor uptake and retention and demonstrated the ability to detect much smaller lesions. The isotope’s longer half-life also means a longer shelf life than currently used diagnostic radiopharmaceuticals, allowing for centralized manufacturing and broader distribution while supporting flexible patient scheduling. These features are not available with gallium-68 and fluorine-18 based diagnostics. Clarity is committed to advancing the development of this best-in-class product to meet the urgent need for more accurate and accessible diagnostic tools in the treatment of prostate cancer.

“This award underlines the potential of ⁶⁴Cu-SAR-bisPSMA is expected to provide a novel diagnostic option for patients with prostate cancer and overcome the limitations of the current generation of diagnostic radiopharmaceuticals,” said Dr. Taylor.

About SAR-bisPSMA

The name SAR-bisPSMA is derived from the word “bis,” which reflects a novel approach that combines two PSMA target drugs with Clarity’s proprietary Sarcophagin (SAR) technology, which securely holds copper isotopes in a cage-like structure called a chelator. Unlike other commercially available chelators, SAR technology prevents copper from leaking into the body. SAR-bisPSMA is a TCT that is treated with isotopes of copper-64 (Cu-64 or ⁶⁴Cu) for imaging and copper-67 (Cu-67 or ⁶⁷Cu) for therapy.

⁶⁴Cu-SAR-bisPSMA and ⁶⁷Cu-SAR-bisPSMA are unregistered products. The data presented in this announcement have not been reviewed by health authorities such as the U.S. FDA. A clinical development program is currently underway to evaluate the efficacy and safety of these products. There is no guarantee that these products will become commercially available.

About Clarity Pharmaceuticals

Clarity is a clinical-stage radiopharmaceutical company focused on treating serious diseases. The company is a leader in innovative radiopharmaceuticals and is developing targeted copper theranostics for the treatment of pediatric and adult cancer based on its SAR technology platform.

www.claritypharmaceuticals.com

For further information please contact:

Clarity Pharma
Dr Alan Taylor Katharina Stark
Executive Chairman Investor/Media Relations
(email protected) (email protected)
+61 406 759 268

This announcement has been authorized for publication by the Executive Chairman.

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