ASX healthcare stock Clarity Pharmaceuticals Ltd (ASX: CU6) is in the spotlight this week. Yesterday, the company released positive news around its new imaging agent.
Let's back up and provide a little context.
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Company overview and trial update
Clarity Pharmaceuticals specialises in the development of Targeted Copper Theranostics (TCT) for the imaging and treatment of selected cancers.
In particular the company works on identification of certain cancer biomarkers. They develop technology to target those biomarkers with either small molecules or monoclonal antibodies.
The company has been engaged in a clinical study.
The study is evaluating the diagnostic performance of the company's 64Cu-SAR-bisPSMA PET imaging agent. The agent aims to detect recurrent prostate cancer in men with rising prostate-specific antigen (PSA) levels after initial treatment.
Importantly, the study compared Clarity Pharmaceuticals' imaging technology with a current standard-of-care PSMA PET scan.
Yesterday, the company released an announcement that the agent showed a 71% true positive rate, meaning that 7 out of 10 positive scans were confirmed as cancer, compared with only 29% for the older agent, 68Ga-PSMA-11.
The biggest improvements were in detecting cancer in the prostate fossa and lymph nodes, where treatment can be curative.
The false negative rate was just 21% for 64Cu-SAR-bisPSMA, versus 65% for 68Ga-PSMA-11, confirming its higher accuracy and reliability.
Interestingly, this ASX healthcare stock shot 17% higher on the news, before cooling off and actually finishing the day down 6%.
Bell Potter provides an update
Following the announcement, Bell Potter released updated guidance on the ASX healthcare stock.
The broker said Professor Louise Emmett presented key findings from the Co-PSMA study on Monday in London at the European Association of Urology annual conference.
The headline data had been released previously and showed that 64Cu-SARbisPSMA PET outperformed 68Ga-PSMA-11 PET in the detection of biochemical recurrence in men with very low PSA levels.
The totality of the data confirms 64Cu SAR bisPSMA is vastly more accurate for the detection of early stage BCR, particularly in men with very low PSA levels consistent with low tumour burden.
The stage is now set for a readout from the approval study for 64Cu-SAR-bisPSMA (AMPLIFY) which has now ceased accepting new patient consents and is practically fully enrolled (n=220). The Co-PSMA data along with data from COBRA and anticipated findings from AMPLIFY will form the basis of submission of a new drug application to be submitted to the FDA.
Upside in tact
Included in the report from Bell Potter was a speculative buy recommendation.
The broker also maintained its price target of $6.40.
From the recent closing price of $3.40, this indicates an upside of 88.2%.
The false negative rate (i.e. no cancer on the PET image, positive on biopsy/pathology) was 21% for 64Cu-SAR-bisPSMA vs 65% for 68Ga-PSMA-11, again demonstrating CU6's product as clearly superior.
We conclude that 64Cu-SARbisPSMA also provides a far more satisfactory level of specificity.
