FDA Grants Fast Track Designation to Clarity Pharmaceuticals’ Novel Treatment for PSMA-Positive Prostate Cancer Lesions

Image Credit: Adobe Stock Images/sderbane

The FDA has granted Fast Track designation to Clarity Pharmaceuticals’ 64Cu-SAR-bisPSMA, a novel imaging agent designed for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)-positive prostate cancer lesions with suspected metastasis. According to the company, the agent, which was supported by promising clinical results, has demonstrated advantages over current diagnostic tools, such as higher tumor uptake, next-day imaging, and a longer half-life, allowing for centralized production and flexible patient scheduling.¹

"Receiving Fast Track Designation for 64Cu-SAR-bisPSMA is a significant milestone, especially as we are actively recruiting into our first registrational Phase III trial, CLARIFY, and preparing for an End of Phase meeting with the FDA for a second pivotal Phase III trial with this product. The designation will allow us to work closely with the FDA to facilitate the development process, potentially accelerating the approval of this best-in-class diagnostic,” said Alan Taylor, PhD, executive chairperson, Clarity Pharmaceuticals, in a press release.

The current clinical program with 64Cu-SAR-bisPSMA includes trials with two indications: patients with prostate cancer prior to undergoing radical prostatectomy, and with biochemical recurrence (BCR) of their disease. The Phase I PROPELLER study found that the imaging agent demonstrated proper safety and efficacy results in patients with prostate cancer prior to radical prostatectomy. As a result, Clarity launched the Phase III CLARIFY trial, which is currently in the enrollment process. Additionally, results from the Phase I/II COBRA trial found that Cu-SAR-bisPSMA was safe and highly effective in detecting prostate cancer lesions in patients with BCR. The company is currently in the planning stages of a Phase III trial for this indication.¹

"We believe that 64Cu-SAR-bisPSMA could be a game changer in prostate cancer diagnosis. Due to its dual targeting structure, bisPSMA, and the longer half-life of copper-64, enabling next-day imaging, this unique product has shown higher tumor uptake and retention and exhibited a capability of detecting much smaller lesions. The longer half-life of the isotope also translates into a longer shelf-life than currently used diagnostic radiopharmaceuticals, allowing for centralized manufacture and wider distribution, while also 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 address the critical need for more accurate and accessible diagnostic tools in prostate cancer management,” said Taylor, in the press release.

According to the American Cancer Society, an estimated one in eight men in the United States will be diagnosed with prostate cancer during their lifespan. It is the second leading cause of cancer deaths in men in the United States, with one in 44 men expected to die from it annually. By the end of 2024, it is estimated that there will be 299,010 new cases of prostate cancer, with 35,250 deaths.²

"This designation highlights the potential of 64Cu-SAR-bisPSMA to provide a novel diagnostic option for patients with prostate cancer and address the limitations of the current-generation diagnostic radiopharmaceuticals," concluded Taylor.

References

1. Clarity receives FDA Fast Track Designation for 64Cu-SAR-bisPSMA. PR Newswire. August 22, 2024. Accessed August 23, 2024. https://www.prnewswire.com/news-releases/clarity-receives-fda-fast-track-designation-for-64cu-sar-bispsma-302228374.html

2. Key Statistics for Prostate Cancer. American Cancer Society. Accessed August 23, 2024. https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html#:~:text=About%201%20in%208%20men,Deaths%20from%20prostate%20cancer