Radiopharm Theranostics (NASDAQ:RADX) today released a highly encouraging second interim data update from its ongoing U.S. Phase 2b clinical trial evaluating RAD 101, a novel FASN-targeting small-molecule imaging agent.
The analysis, which included 20 patients with suspected recurrent brain metastases, revealed a 90% concordance rate (18 out of 20 patients) between PET imaging and MRI—the study’s primary endpoint.
These results underscore the agent's ability to provide high-contrast, selective tumor uptake, particularly in cases where standard MRI findings remain equivocal or difficult to interpret.
The trial specifically investigates the utility of RAD 101, radiolabeled with Fluorine-18, in distinguishing between recurrent disease and common "treatment effects" like radiation necrosis.
Distinguishing these two states is a critical diagnostic gap in neuro-oncology; current imaging often fails to tell them apart, leading to delayed or inappropriate treatment.
The interim data also provided a first look at secondary objectives, with the first five evaluable patients showing positive trends in sensitivity and specificity based on six-month follow-up and biopsy data.
CEO and Managing Director Riccardo Canevari noted that the consistency of these results bolsters confidence in the agent's commercial and clinical potential.
Radiopharm previously secured FDA Fast Track Designation for RAD 101, a status that facilitates frequent communication with the regulator and can lead to accelerated approval.
By targeting fatty acid synthase (FASN)—an enzyme overexpressed in many solid tumor metastases—RAD 101 offers a metabolic "map" of the disease that complements the anatomical data provided by MRI.
The company is now moving toward the final data readout for the full 30-patient study, which is expected by June 2026.
Successful final results will serve as the foundation for a pivotal Phase 3 trial design.