Clarity progresses SECuRE trial with positive safety results

Clarity Pharmaceuticals Ltd (ASX:CU6) has reported positive results from a further stage of its theranostic prostate cancer trial – known as SECuRE – with data from all 3 patients in a fourth cohort indicating the safety of drug Cu-SAR-bisPSMA at its highest dose.

SECuRE is a Phase I/IIa theranostic trial which aims to identify and treat patients who have prostate-specific membrane antigen (PSMA)-expressing metastatic castrate-resistant prostate cancer (mCRPC).

The overall aim of the trial – which involves around 44 participants in the United States and Australia – is assessment of how safe and effective Cu-SAR-bisPSMA is in treating this type of cancer.

Data from 3 participants in Cohort 4 – the first part of the trial assessing multiple cycles of the drug at its highest dose of 12GBq – was assessed by the Safety Review Committee (SRC), with findings indicating only mild or moderate adverse events (AEs) among participants.

These 3 participants had received 2 doses of the drug, with 2 having completed the dose limiting toxicity (DLT) period, while another is set to complete the DLT period by the end of September.

So far, no DLTs were observed – and this was in line with cohorts 1, 2 and 3.

Clarity Executive Chairperson Dr Alan Taylor said all indicators from this stage of the trial had built confidence in the drug.

“The results from the SECuRE trial continue to impress, with the data from all 3 participants in cohort 4 exhibiting an excellent safety profile for Cu-SAR-bisPSMA, following 2
cycles of the product at the highest dose of 12GBq,” he said.

“The early approval by the SRC to progress with the trial and the excellent safety data to date reinforce our confidence that Cu-SAR-bisPSMA has a favourable safety profile as we
consider the dosing schedule for the next phase of the trial.

“Although safety is our priority during this dose escalation phase, the efficacy data continues to be outstanding, with both participants who have thus far completed the DLT period analysis exhibiting an excellent response to treatment even at these early time points, and as shown in the image, in large amounts of bulky disease.

“It is important to note that participants who exhibited strong efficacy data in previous
cohorts experienced the maximum effect several months after receiving Cu-SAR-bisPSMA (in some cases, almost 5 months after receiving one single dose of the product).”

Clarity’s share price has risen on the news, and at 12:09 AEST, shares were trading at $7.55 – a rise of 2.37% since the market opened. Its announcement also drew one of the largest cluster of comments on the Hot Copper investors’ forum.