Poolbeg Pharma (AIM:POLB) has secured MHRA Clinical Trial Authorisation for POLB 001’s TOPICAL study and says site initiation visits are scheduled with patient screening to start shortly, keeping an interim data readout on track for this summer.
The trial will test POLB 001 as a preventative therapy for cytokine release syndrome (CRS) in roughly 30 relapsed/refractory multiple myeloma patients receiving the bispecific antibody teclistamab, supplied by Johnson & Johnson at no cost. The study now runs across six UK sites, including NHS Lothian and Royal Stoke University Hospital.
Poolbeg highlighted the trial’s potential for a rapid readout because CRS typically appears within days or weeks of bispecific antibody initiation.
Independent US payer research by Acumetis Global, which engaged payers covering about 75 million lives across commercial, Medicare and Medicaid plans, reconfirmed a “clearly defined value proposition” for a preventative CRS therapy. The report emphasised potential hospital cost savings, a shift of care toward outpatient/community settings, and payer willingness to support commercially meaningful pricing that could underpin multi‑billion‑dollar US peak sales.
"We have made excellent progress on the TOPICAL clinical trial, with all regulatory approvals now received, additional trial sites added to the study, and site initiation visits scheduled, we are on track to achieve interim data this summer." — Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg Pharma.
