RAD 101 Achieves 92% MRI Concordance in Phase 2b Brain Imaging Study

Promising Interim Results in Brain Metastases Imaging

Radiopharm Theranostics has announced encouraging interim data from its Phase 2b clinical trial evaluating RAD 101, a novel imaging agent designed to detect recurrent brain metastases. The trial, conducted in the U.S., revealed that 92% of evaluable patients showed concordance between RAD 101 PET imaging and conventional MRI scans, the study’s primary endpoint. This high level of agreement underscores RAD 101’s potential as a complementary diagnostic tool in a challenging clinical area.

Innovative Targeting of Fatty Acid Synthase

RAD 101 distinguishes itself by targeting fatty acid synthase (FASN), an enzyme overexpressed in many solid tumors, including brain metastases. Radiolabelled with Fluorine-18, RAD 101 leverages PET imaging to highlight metabolic activity in suspected or recurrent brain lesions. This approach may offer more precise detection compared to MRI alone, particularly in cases where MRI findings are equivocal, potentially improving treatment decisions for patients.

Regulatory Momentum and Market Potential

The U.S. Food and Drug Administration has granted RAD 101 Fast Track designation, reflecting the unmet need in distinguishing tumor recurrence from treatment effects in brain metastases. With over 300,000 patients diagnosed annually in the U.S. alone, the market opportunity for RAD 101 is substantial, with independent assessments estimating annual revenues exceeding $500 million. Radiopharm aims to leverage these interim results to initiate a pivotal study by the end of 2026, accelerating the path toward potential regulatory approval and commercialisation.

Ongoing Trial and Future Outlook

The Phase 2b trial is currently halfway enrolled, targeting 30 patients with confirmed recurrent brain metastases from various solid tumors. Secondary endpoints include assessing RAD 101’s accuracy, sensitivity, and specificity in differentiating tumor recurrence from radiation necrosis. The company’s leadership expresses confidence that integrating RAD 101 PET imaging with standard MRI could transform patient management, offering clinicians a more reliable diagnostic tool in a complex therapeutic landscape.

Engagement and Transparency

To discuss these findings and next steps, Radiopharm will host a webinar featuring its CEO Riccardo Canevari and key medical officers. This engagement reflects the company’s commitment to transparency and investor communication as it advances its clinical programs and prepares for pivotal trials.