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Highlights
- US FDA clearance has been received for the Investigational New Drug (IND) application for RAD 101.
- The FDA IND approval marks a significant milestone towards commencing the Phase 2b imaging trial in brain metastases.
- First patient dosing is expected during the fourth quarter of 2024.
Radiopharm Theranostics Limited (ASX: RAD) has achieved a significant milestone with the clearance of its IND application for F18-Pivalate (RAD 101) by the US FDA. This approval paves the way to start the Phase 2b multi-centre trial aimed at imaging brain metastases.
The IND approval demonstrates clear recognition of the clinical data already generated for RAD 101 by the US FDA.
The company expects to dose first patient in the fourth quarter of 2024 and the 30-patient Phase 2b read-out is anticipated by mid-2025, based on the current enrolment expectations.
Following this, the company plans to proceed with a Phase 3 registrational study
About F18-Pivalate
Pivalate is a small molecule designed to selectively target fatty acid synthetase, an enzyme that exhibits elevated expression levels in brain tumours remains at normal levels in healthy cells. Clinical investigation is currently underway for this novel proprietary imaging agent aimed at identifying and characterising brain metastases.
The Phase 2a imaging trial of Pivalate, conducted at the Imperial College of London, yielded positive results. The trial involved 17 patients with brain metastases and demonstrated significant tumour uptake consistent across various tumour origins. These findings demonstrate the potential of Pivalate as a valuable tool for monitoring brain metastases.
Radiopharm has secured a worldwide license for the pivalate platform technology. The company is actively partnering with the Imperial College of London on developing a therapeutic candidate that operates through the same mechanism of action.
RAD share performance
RAD shares traded at AU$0.039 apiece, up 2.6%, at the time of writing on 23 July with a market cap exceeding AU$40 million.
