- 01FDA grants Clarity breakthrough status for imaging.
- 02Data suggest better detection vs standard PSMA PET.
- 03Phase III recruitment complete; topline due mid-2027.
The US Food and Drug Adminstration has granted Clarity Pharmaceuticals (ASX: CU6) breakthrough therapy designation for 64Cu-SAR-bisPSMA used in positron emission tomography (PET) for men with suspected biochemical recurrence (BCR) of prostate cancer, based on elevated serum prostatespecific antigen levels.
The designation was supported by data from a Phase II Co-PSMA trial, Phase I/II COBRA trial and real-world evidence, which collectively indicated enhanced diagnostic performance of the theranostic over standard-of-care prostate-specific membrane antigen (PSMA) PET in patients.
Clarity is currently conducting two registrational Phase III trials—Amplify, for patients with BCR; and Clarify, for high-risk cases prior to radical prostatectomy—at clinical sites in the US and Australia, with recruitment completed and patient follow-up progressing.
Topline data from both trials is due before mid-2027 and final study results are expected to support an FDA application for approval of 64Cu-SAR-bisPSMA as a new diagnostic imaging agent in prostate cancer patients.
The American Cancer Society estimates there will be about 333,830 new cases of prostate cancer in the US in 2026 and around 36,320 deaths from the disease.
Expedited Development
Breakthrough therapy designation is designed to expedite the development and review of drugs that are intended to treat serious conditions where preliminary clinical evidence indicates the agent of interest may demonstrate substantial improvement over available therapy on a clinically significant endpoints.
It is one step higher than the FDA’s fast track designation and is seen as a positive indicator of potential eligibility for priority review due to overlapping qualifying criteria.
Clarity executive chair Dr Alan Taylor said the designation was “one of the most significant milestones” in the company’s prostate cancer program, the importance of which “is further amplified given that fewer than half of designation requests across all therapeutic areas are successful.”
“The FDA’s award of the first breakthrough therapy designation in the history of PSMA PET imaging highlights the unmet need for more accurate detection of recurrent prostate cancer lesions and the significance of the data generated to date, which indicates improved diagnostic performance of 64Cu-SAR-bisPSMA compared to standard of care PSMA PET in patients with BCR of prostate cancer.”
Novel Therapeutic Approach
SAR-bisPSMA derives its name from the word “bis”, reflecting a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine technology which securely holds copper isotopes inside a cage-like structure called a chelator to prevent copper leakage into the body during medical imaging and targeted cancer therapy.
The field of PSMA PET imaging has evolved rapidly over the past few years to become a blockbuster global market with current US sales of around $2.92 billion per year expected to grow to over $4.38b by 2029.
“The substantial and growing PSMA PET market represents a significant opportunity for Clarity, but our ambition extends well beyond market size,” Dr Taylor said.
“Our focus remains firmly on developing products that will improve the outcomes of patients with cancer, and breakthrough therapy designation is an important step in moving towards this goal.”
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