Clinical-stage radiopharmaceutical company Clarity Pharmaceuticals (ASX:CU6) has announced the approval of its Investigational New Drug (IND) application by the US FDA to evaluate its SAR-Bombesin product for the identification and treatment of metastatic castrate-resistant prostate cancer (mCRPC).

Executive chairman Dr Alan Taylor said, “This trial with SAR-Bombesin marks our third therapy program, and sixth program overall, in the Targeted Copper Theranostic pipeline that is progressing through clinical trials in the US.

“Receiving clearance from the FDA is yet another significant milestone for the company as it continues to showcase the capabilities of Clarity’s small but high-performing team in developing next-generation theranostics from the benchtop, through preclinical studies and into clinical trials in the largest pharmaceutical market in the world. This is Clarity’s fifth IND, highlighting our strategy of developing radiopharmaceuticals for the very large US market.”

This IND gives Clarity clearance to proceed with a US-based Phase I/IIa ⁶⁴Cu/⁶⁷Cu SAR-Bombesin theranostic trial for identification and treatment of mCRPC that is expressing the Gastrin-Releasing Peptide receptor (GRPr).

COMBAT (Copper-67 SAR Bombesin in metastatic castrate-resistant prostate cancer) is a dose escalation study with a cohort expansion.

The company said the aim of the study is to determine the safety and efficacy of ⁶⁷Cu-SAR-Bombesin in participants with GRPr-expressing mCRPC in patients who are ineligible for therapy with ¹⁷⁷Lu-PSMA-617.

Clarity’s executive chairman Dr Alan Taylor commented, “We look forward to further progressing the development of SAR-Bombesin as a theranostic under this trial, as well as a stand-alone diagnostic agent under the SABRE and BOP clinical trials that are currently progressing in the US and Australia respectively.

“The diagnostic SAR-Bombesin product has already shown utility in improving the management of disease for PSMA-negative prostate cancer patients and, given the mounting clinical and preclinical data to date, we believe that it has potential to provide this large patient population with more accurate and precise detection and treatment of disease.

“SAR-Bombesin is a pan-cancer product, and the open IND offers exciting opportunities for exploring new theranostic indications with this versatile product as Clarity pursues our ultimate goal of improving treatment outcomes for children and adults with cancer.”