The Clarity Pharmaceuticals Ltd (ASX: CU6) share price is in focus today after the company reported encouraging interim results from its SECuRE Phase I/IIa trial in metastatic castration-resistant prostate cancer (mCRPC), including strong PSA response rates and two additional complete responses at a higher dose level.
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What did Clarity Pharmaceuticals report?
- 19 participants from the SECuRE trial received the 8 GBq 67Cu-SAR-bisPSMA dose (data cut-off: 20 July 2026).
- 74% achieved a PSA25 response (≥25% reduction in PSA), 63% saw PSA50, 53% reached PSA75, and 26% achieved PSA90.
- 81% (13/16) of evaluable participants showed disease control, including 31% (5/16) complete responses/undetectable disease.
- Five out of seven total complete responses came from the 8 GBq dose cohorts.
- The median number of treatment cycles was two, with mild or moderate adverse events most commonly reported.
What else do investors need to know?
The SECuRE trial is in its Cohort Expansion phase, recruiting patients at the 8 GBq dose in the US. Most participants had previously undergone multiple lines of therapy, highlighting the advanced nature of their disease.
Clarity's proprietary SAR-bisPSMA platform is showing promising anti-tumour activity even after a small number of treatment cycles. The company is also evaluating 8 GBq 67Cu-SAR-bisPSMA in combination with enzalutamide based on positive results from other prostate cancer studies.
What did Clarity Pharmaceuticals management say?
Clarity's Executive Chairperson, Dr Alan Taylor, said:
The SAR-bisPSMA product continues to generate an impressive body of evidence in clinical trials and case studies, highlighting the strength of the evidence in both diagnostic and theranostic applications. Most impressively, despite the relatively small numbers of patients enrolled in the SECuRE trial to date, and most having received up to 2 treatment cycles at 8 GBq, we see a trend that is impossible to ignore. We continue seeing patients with mCRPC, who have gone through numerous lines of therapy prior to the SECuRE study enrolment, achieve undetectable disease and/or complete response following 67Cu-SAR-bisPSMA treatment. Seven participants have now achieved undetectable disease and/or complete response across all cohorts (assessed by RECIST, bone scan and/or PSA), and five of these are from the 8 GBq cohorts. This means that almost a third of all evaluable patients treated at this dose level have achieved a complete response and/or undetectable disease.
What's next for Clarity Pharmaceuticals?
The SECuRE trial will continue recruiting for its Cohort Expansion phase, with planning underway for a Phase III registrational study. Clarity remains committed to developing SAR-bisPSMA for prostate cancer patients who have limited treatment options.
Longer term, Clarity aims to apply its unique theranostic technology to bring new diagnostic and therapeutic choices for prostate cancer, and potentially other cancers as well.
Clarity Pharmaceuticals share price snapshot
Over the past 12 months, Clarity Pharmaceuticals shares have declined 38%, trailing the All Ordinaries Index (ASX: XAO), which has risen 3% over the same period.
