Radiopharm Theranostics (ASX:RAD) has reached a pivotal milestone in the oncology sector, announcing the completion of enrolment for its US Phase 2b imaging trial of RAD 101.
The clinical-stage biopharmaceutical firm, headquartered in Sydney, confirmed that the final patient has been dosed in the multicentre study, which targets the detection of recurrent brain metastases.
The diagnostic tool is a novel small molecule designed to identify fatty acid synthase, a protein frequently overexpressed in solid tumours.
The clinical significance of this development is underscored by interim data showing a 90% concordance with conventional MRI, which serves as the trial's primary endpoint.
Managing Director and CEO Riccardo Canevari noted that these results reinforce the company’s confidence in the programme's momentum.
By identifying cancer cells through FASN activity, RAD 101 aims to distinguish between actual recurrent disease and standard treatment effects, addressing a critical gap in current neuro-oncology diagnostics.
With more than 300,000 patients diagnosed annually with cerebral metastases in the United States alone, the demand for high-precision imaging is escalating.
Radiopharm has already secured FDA Fast Track designation for the candidate, a move intended to accelerate the regulatory process for life-threatening conditions.
The company now looks towards June for the full clinical trial readout.
Following the results, the firm plans to initiate a US Phase 3 pivotal trial and engage in formal dialogue with the FDA to establish the optimal pathway for commercialisation and clinical integration.
At the time of reporitng, Radiopharm Theranostics' share price was $0.020.