• Interim data review of Cohort Expansion Phase (Phase II) of SECuRE trial
• Safety Review Committee confirms trial will continue with no protocol modifications
• Promising efficacy and favorable safety profile of 67Cu-SAR-bisPSMA

Clarity Pharmaceuticals has announced that the SECuRE trial for its 67Cu-SAR-bisPSMA product will continue with no modifications to the protocol following an interim data review by the Safety Review Committee (SRC). The interim assessment included data from nine participants in the Cohort Expansion Phase (Phase II) of the trial, with the majority having bone metastasis and receiving multiple previous anti-cancer treatments. The results continue to demonstrate a favorable safety profile, with most related adverse events being Grade 1 or 2. Efficacy data is also promising, with six out of the nine participants showing PSA reductions of 50% or more, and two achieving reductions of 80% or more. Notably, one participant achieved undetectable PSA and no detectable disease after three cycles of 67Cu-SAR-bisPSMA, with only mild adverse events reported. The SRC has recommended that the SECuRE trial continue as planned, with recruitment for the Cohort Expansion Phase ongoing. Clarity is also progressing plans for a Phase III registrational trial based on the data generated to date.

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Clarity is progressing plans for a Phase III registrational trial for 67Cu-SAR-bisPSMA based on the data generated to date from the SECuRE trial.