Radiopharm Theranostics (ASX:RAD) announced a clinical milestone, revealing that its novel imaging agent, RAD 101, achieved its primary endpoint in 90% of patients during a Phase 2b interim analysis.
The study focuses on the detection of recurrent brain metastases, a critical diagnostic gap in neuro-oncology.
Out of 20 evaluable patients, eighteen showed high concordance between RAD 101 PET imaging and standard MRI results.
The radiolabelled small molecule—which targets fatty acid synthase—demonstrated significant and selective tumor uptake, providing clear metabolic evidence of disease even in cases where MRI findings were previously equivocal.
Beyond the primary endpoint, the company reported encouraging secondary data regarding diagnostic accuracy.
Preliminary results from the first five patients with six-month follow-up or biopsy data indicate a positive trend in both sensitivity and specificity.
The metrics are vital for distinguishing between actual recurrent disease and the lingering effects of previous treatments, such as radiation necrosis.
Riccardo Canevari, CEO of Radiopharm Theranostics, noted that the results validate RAD 101's potential to support more accurate, timely treatment decisions for patients with solid tumors of various origins.
With US FDA Fast Track Designation already secured, the company is now looking toward a final 30-patient data readout in June.