Poolbeg Pharma plc (AIM: POLB) has received Clinical Trial Authorisation (CTA) from the Medicines and Healthcare products Regulatory Agency for its POLB 001 TOPICAL trial, marking a key regulatory milestone as the study moves toward delivering interim data this summer.
POLB 001 is being developed as a potential first preventative treatment for cancer immunotherapy-induced cytokine release syndrome (CRS). The TOPICAL trial will enrol around 30 patients with relapsed or refractory multiple myeloma receiving the bispecific antibody teclistamab, supplied at no cost by Johnson & Johnson.
The study now spans six UK sites, with additional centres including NHS Lothian and Royal Stoke University Hospital joining established locations such as The Christie and The Royal Marsden. Patient screening is expected to begin shortly, with the trial designed to deliver a relatively rapid readout given the acute nature of CRS.
Separately, independent payer research conducted by Acumetis Global points to significant commercial potential, indicating that POLB 001 could achieve multi-billion-dollar peak sales in the U.S. market.
The study highlighted the substantial clinical and economic burden of CRS, which occurs in many CAR-T and bispecific antibody treatments and can delay or halt life-saving therapies. Findings suggest that an effective preventative treatment could reduce hospitalisation costs and enable a shift toward outpatient care, making it attractive to healthcare payers.
Chief executive Jeremy Skillington said the company remains on track to deliver interim data this summer, adding that the research provides external validation of both the clinical relevance and commercial opportunity of POLB 001.
