CU6.ASX: SECuRE trial update

SECuRE trial update

Stock	Clarity Pharmaceuticals Ltd (CU6.ASX)
Release Time	5 Mar 2025, 9:55 a.m.
Price Sensitive	Yes

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SECuRE trial update: Positive results lead to Cohort Expansion Phase

Key Points

92% of pre-chemo participants experience >35% drop in PSA levels
Cohort Expansion Phase commences with increased dose and cycles
Favorable safety profile with majority of adverse events being Grade 1-2

Full Summary

Clarity Pharmaceuticals has announced the completion of the Dose Escalation Phase of the SECuRE trial (NCT04868604) for its 67Cu-SAR-bisPSMA product. The Safety Review Committee (SRC) has recommended the trial progress to the Cohort Expansion Phase (Phase II) at the 8 GBq dose level based on the favorable safety and efficacy data demonstrated across all cohorts. Notably, 68% of participants have shown reductions in PSA levels, despite the majority (77%) receiving only a single dose of 67Cu-SAR-bisPSMA. The trial has also observed a complete response and several partial responses based on RECIST criteria. The safety profile of 67Cu-SAR-bisPSMA has been favorable, with the majority of adverse events being Grade 1-2. Importantly, in the group of 13 pre-chemotherapy participants, all but one had PSA drops of 35% or more, with almost half achieving reductions of 80% or more. Disease control was also observed in 92% of these pre-chemotherapy participants. The trial protocol has been amended to bring 67Cu-SAR-bisPSMA to participants at earlier stages of their disease, in the pre-chemotherapy setting, and to increase the number of participants in the Cohort Expansion Phase from 14 to 24, with a subset receiving the combination of 67Cu-SAR-bisPSMA and enzalutamide.

Guidance

Clarity Pharmaceuticals expects to progress the SECuRE trial to a Phase III pivotal trial. The company is focused on bringing 67Cu-SAR-bisPSMA to earlier lines of prostate cancer therapy, with the potential combined market value of PSMA-targeted products estimated at approximately US$10-15 billion by 2030.

Outlook

Clarity Pharmaceuticals is excited about the future of 67Cu-SAR-bisPSMA and is working to bring this promising product to patients in a timely manner while adhering to the highest standards of clinical research. The company is looking forward to swiftly recruiting into the next phase of the SECuRE trial.