Poolbeg Pharma (AIM: POLB; OTC: POLBF; FRA: POLBF) has announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted the company clinical trial authorization for its TOPICAL trial with interim data expected summer 2026.
According to Poolbeg, 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.
In a statement, Jeremy Skillington, CEO of Poolbeg, commented, “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.”
He added, “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.”
