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Early patient data from Phase 2b clinical trial showed significant and selective tumor uptake in brain metastases compared to MRI
Phase 2b clinical trial expected to complete enrollment and have topline data in 1H26
SYDNEY, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced that the Phase 2b trial evaluating RAD101 imaging in brain metastases has achieved 50% patient enrollment threshold.
RAD101 is the Company's novel imaging small molecule that targets fatty acid synthase (FASN), a multi-enzyme protein that catalyses fatty acid synthesis and is overexpressed in many solid tumors, including Brain metastases.
Data from the first three patients showed significant and selective tumor uptake in brain metastases. Images confirmed metabolic activity in brain metastases compared to equivocal MRI findings. These promising early results are in line with the previously published Phase 2a results and, if confirmed, will trigger the preparation of a multi-center, global Phase 3 registrational trial.
In the U.S. alone, there are more than 300,000 patients diagnosed annually with cerebral metastases. The incidence of Intracranial Metastatic Disease (IMD) continues to increase, in part, due to improvements in systemic therapy resulting in a more durable control of the Primary tumor. Contrast-enhanced Magnetic Resonance Imaging (CE-MRI) is the preferred method for imaging IMD, but has limitations, particularly in follow-up surveillance scans to optimise patient care.
RAD101 has received U.S. Food and Drug Administration (FDA) Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin including leptomeningeal disease.
Posted In: RADX
