Biopharmaceutical company Poolbeg Pharma plc (AIM: POLB) announced on Wednesday that it has received Clinical Trial Authorisation from the UK Medicines and Healthcare products Regulatory Agency for its POLB 001 TOPICAL trial, with interim data expected in summer 2026. Site initiation visits are underway and patient screening is set to begin shortly across six UK locations.

The TOPICAL trial will evaluate POLB 001 as a potential preventative treatment for cancer immunotherapy-induced Cytokine Release Syndrome in approximately 30 relapsed or refractory multiple myeloma patients receiving teclistamab, supplied by Johnson & Johnson at no cost. The study design is expected to enable rapid data readout due to the acute onset of the condition.

Separately, independent US payer research conducted by Acumetis Global indicates a multi-billion-dollar peak sales opportunity for POLB 001. The findings highlight strong demand for a preventative therapy that could reduce hospitalisation costs, support a shift to outpatient care and address the lack of predictive diagnostics for Cytokine Release Syndrome.

Poolbeg Pharma stated that the research reinforces the commercial and clinical value proposition of POLB 001, supporting its potential role in expanding access to cancer immunotherapies and enhancing partnership prospects.