Radiopharm achieves primary endpoint in 92% of patients in RAD 101 trial

Radiopharm (RADX) Theranostics announced interim data from the first twelve patients in its U.S. Phase 2b clinical imaging trial of RAD 101 in brain metastases. RAD 101 is Radiopharm’s novel, small-molecule imaging agent targeting fatty acid synthase and radiolabelled with Fluorine-18 for the diagnosis of suspected recurrent brain metastases from solid tumors of different origins, also known as the Pivalate technology. The interim analysis showed that 92% of the patients treated with RAD 101 achieved concordance with MRI as assessed by PET imaging of brain metastases. The results showed significant and selective tumor uptake in the brain metastases. Images confirm metabolic activity in brain metastases compared to equivocal MRI findings. The Company recently achieved 50% patient enrollment in the Phase 2b trial evaluating RAD 101 imaging in brain metastases and RAD 101 has received U.S. Food and Drug Administration Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin, including leptomeningeal disease.