Radiopharm Theranostics received FDA IND approval for a Phase 2b imaging trial in brain metastases

Radiopharm Theranostics Limited (ASX: RAD) received clearance for its Investigational New Drug application with the US FDA for F18-Pivalate. F18-Pivalate is a small molecule labeled with the radioisotope F18, which selectively targets fatty acid synthetase, a protein overexpressed in brain tumors but not normal cells. It is a novel proprietary imaging agent under clinical investigation for detecting and characterizing brain metastases.

The FDA's approval of the IND recognizes the clinical data already generated for F18-Pivalate and marks a significant milestone toward starting a Phase 2b multi-center trial for the imaging of brain metastases. Radiopharm anticipates dosing the first patient during the fourth quarter of 2024. Based on current enrollment expectations, the 30-patient Phase 2b read-out is expected by mid-2025, followed by a Phase 3 registrational study.

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