Clarity Pharmaceuticals’ (ASX:CU6) new milestone: FDA approves imaging trial

Clarity Pharmaceuticals (ASX:CU6), a clinical-stage radiopharmaceutical company, is riding high backed by an upbeat update on a significant milestone.

The company’s Investigational New Drug (IND) application for its SAR-Bombesin product has received approval from the United States Food and Drug Administration (US FDA). The application is focused on the evaluation of sarcophagine (SAR)-Bombesin product as an imaging agent in prostate cancer patients that are Prostate-Specific Membrane Antigen (PSMA)-negative.

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Commenting on the development, Clarity’s Executive Chairman, Dr Alan Taylor, said, “Receiving clearance from the FDA on the imaging trial with SAR-Bombesin is yet another significant milestone for Clarity. It shows our ability to develop cutting-edge theranostics from the lab, through preclinical studies and into clinical trials, with SAR-Bombesin being Clarity’s fourth IND across five products which are clear for investigation in the US.”

CU6 is developing next-generation products to address the increasing medical needs in the oncology space. The company is developing targeted copper theranostics based on its SAR technology platform for treating cancer. SAR-Bombesin is a Targeted Copper Theranostic that can be used with isotopes of copper for imaging and therapy purposes.

Trial details

Approval of the IND application allows Clarity to proceed with a US-based Phase II 64Cu SAR-Bombesin Positron Emission Tomography (PET) imaging trial in participants with PSMA-negative BCR of prostate cancer following definitive therapy.

The multi-centre, non-randomised, single-arm, open-label trial will involve up to 50 PSMA-negative patients with known or presumed prostate cancer.

Data source: company update

The trial builds upon the encouraging clinical data from the pilot trial assessment of 64Cu SAR-Bombesin in breast cancer. The trial was developed in response to the intense demand for this product from clinicians with prostate cancer patients whose cancer was undetected with currently approved PSMA diagnostic agents or standard imaging technology.

Primary objective of the trial is to examine the safety and tolerability of 64Cu SAR-Bombesin, plus its potential to accurately detect the reappearance of prostate cancer.

The way ahead

CU6 plans an IND submission for a theranostic trial in prostate cancer participants, using 67Cu SAR-Bombesin therapy paired with the imaging agent, 64Cu SAR-Bombesin.

The company expects the SABRE trial to commence shortly and the theranostic trial to commence in 2023.

CU6 shares traded at AU$0.470 on 6 June 2022, down 1.052% from the last closing price.

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