Poolbeg Pharma PLC (AIM:POLB, OTC:POLBF, FRA:POLBF), the AIM-listed clinical-stage biopharmaceutical company, has received clinical trial authorisation from the UK Medicines and Healthcare products Regulatory Agency for its TOPICAL trial, with interim data expected this summer.
The trial is investigating POLB 001, which is being developed as a potential first-approved preventative therapy for cytokine release syndrome (CRS), a serious immune reaction triggered by cancer immunotherapies, including CAR T-cell therapies and bispecific antibodies.
The TOPICAL study will enrol around 30 patients with relapsed or refractory multiple myeloma receiving teclistamab, a bispecific antibody supplied by Johnson & Johnson at no cost to Poolbeg.
The trial now spans six UK sites: The Christie, The Royal Marsden, University College London Hospitals, University Hospitals Birmingham, NHS Lothian in Edinburgh, and Royal Stoke University Hospital.
Site initiation visits are scheduled and patient screening is set to commence shortly.
Poolbeg also published findings from independent US payer research conducted by Acumetis Global, which engaged payers covering approximately 75 million lives across commercial insurance, Medicare and Medicaid.
The research identified multi-billion-dollar peak sales potential in the United States and confirmed willingness to pay at commercially meaningful price points, driven by POLB 001's potential to reduce hospitalisation costs and shift care away from specialist centres toward outpatient settings.
CRS occurs in the majority of patients receiving CAR T and bispecific antibody treatments, with no established diagnostic method currently available to predict either the likelihood or severity of the reaction in individual patients.
High-grade CRS forces permanent discontinuation of treatment, cutting patients off from potentially life-saving therapies.
Chief executive Jeremy Skillington said the regulatory clearance, expanded site network and independent commercial validation collectively reinforce the company's confidence in POLB 001's ability to deliver meaningful value to healthcare systems.
Skillington added that the prevention of CRS has the potential to expand the number of patients able to receive cancer immunotherapies and improve the quality of life for those who do.