Poolbeg Pharma (POLB) has announced the activation of the first clinical trial site for its POLB 001 TOPICAL study, marking a key operational milestone as the company advances its lead programme aimed at preventing Cytokine Release Syndrome (CRS) in cancer patients receiving immunotherapy.
The site activation follows the successful completion of the site initiation visit, with patient recruitment now underway. Poolbeg expects interim data from the study during summer 2026.
The TOPICAL (Trial of Prevention of ImmunoCytokine Adverse events in Myeloma) study is being conducted by Accelerating Clinical Trials (ACT) and will enrol about 30 patients with relapsed or refractory multiple myeloma. The trial is investigating POLB 001 as a preventative treatment for CRS in patients receiving the approved bispecific antibody teclistamab.
CRS is a potentially serious inflammatory response that can occur within days or weeks of starting bispecific antibody treatment. Poolbeg expects the trial to generate a relatively rapid data readout.
The company said the level of engagement from investigators and clinical teams highlights both the unmet need for improved CRS management and the potential role of POLB 001 in supporting wider adoption of cancer immunotherapies.
Poolbeg's Chief Executive Officer Jeremy Skillington said: "The successful site activation marks a significant milestone for Poolbeg and our lead programme, POLB 001. We believe POLB 001 has the potential to transform the cancer immunotherapy field through the prevention of CRS. This could not only improve patient quality of life but also expand the number of patients that can receive these life-saving cancer immunotherapies. We look forward to receiving the first insights from the study and sharing these with prospective partners, the market, and the wider scientific community in due course."
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The activation of the first trial site moves POLB 001 from preparation into patient recruitment and keeps the programme on track for interim data this summer. With CRS remaining a significant challenge for cancer immunotherapies, positive clinical results could strengthen the commercial and partnering potential of Poolbeg's lead asset.