Clarity Pharmaceuticals Ltd (ASX: CU6) shares are scaling new heights on Thursday.
In morning trade, the ASX biotech share climbed 4% to a new record high of $7.67.
This means its shares are now up 24% since this time last month.
Why is this ASX biotech share breaking records?
Investors have been buying this clinical stage radiopharmaceutical company's following the release of an update on its SECuRE trial.
The SECuRE trial is a Phase I/IIa theranostic trial for the identification and treatment of participants with prostate-specific membrane antigen (PSMA)-expressing metastatic castrate-resistant prostate cancer (mCRPC) using 64Cu/67Cu-SAR-bisPSMA.
64Cu-SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm, dose escalation study with a cohort expansion involving approximately 44 participants in the US and Australia.
The overall aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of prostate cancer.
What was today's update?
According to the release, a safety review has been undertaken for the first three participants enrolled in cohort 4 of the SECuRE trial who received two doses of 67Cu-SAR-bisPSMA.
Two of these participants have completed the dose limiting toxicity (DLT) period and one will complete the DLT period by the end of September. Importantly, no DLTs were observed to date, which is in line with cohorts 1, 2 and 3.
Furthermore, the safety profile of multiple doses of 67Cu-SAR-bisPSMA remains positive, with almost all adverse events (AEs) being mild or moderate. In addition, almost all AEs have either resolved or improved at the last assessment.
The preliminary efficacy assessment from cohort 4 after two therapy cycles in two participants has also been positive. Following completion of the DLT period, it showed that both participants exhibited greater than 60% drops in prostate-specific antigen (PSA) levels in weeks following their second dose.
The ASX biotech's executive chair, Dr Alan Taylor, was pleased with the impressive results. He said:
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 67Cu-SAR-bisPSMA, following 2 cycles of the product at the highest dose of 12GBq. The early approval by the SRC to progress with the trial and the excellent safety data to date reinforce our confidence that 67Cu-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. […] The data from all cohorts is now presenting a unique proposition of a great safety profile coupled with remarkable efficacy, even in patients who had failed so many previous lines of therapy.
