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Poolbeg Pharma PLC said full UK regulatory clearance has been secured for its lead asset, POLB 001, clearing the final hurdle for the company’s clinical trial to proceed in the United Kingdom. The company expects to begin recruitment shortly after confirming six clinical sites, with interim data anticipated later this summer.
Poolbeg Pharma’s CEO Jeremy Skillington and principal scientist Liam Tremble said the Medicines and Healthcare products Regulatory Agency (MHRA) clearance allows the POLB 001 clinical trial to move forward. Tremble said the company submitted preclinical, clinical and manufacturing data for review, with the regulator assessing both safety for human use and whether the trial protocol is properly designed.
He added that, alongside MHRA approval, Health Research Authority approval and ARSAC approval (radiation approval) are also in place, meaning all regulatory approvals required to proceed with the study have been obtained.
Tremble said the company has confirmed additional trial locations, bringing the total to six clinical sites. The newly added sites are NHS Lothian in Edinburgh and the Royal Stoke University Hospital.
He said site initiation visits are scheduled and, if timelines hold, the company expects patients to be screened and recruited “very soon.” Tremble noted that the trial is designed around cytokine release syndrome (CRS), an acute condition associated with certain immunotherapies, and that the risk window occurs early in treatment.
Because the risk period is within the first couple of weeks, the company expects data to accumulate quickly, supporting its plan to deliver interim data later this summer.
Skillington said Poolbeg Pharma conducted independent US payer research to support discussions with potential partners. He described the work as interviews with commercial insurers, Medicare and Medicaid providers covering more than 75 million lives.
The company said the research was intended to quantify the economic burden of CRS and evaluate the potential value of a preventative solution, including confirming the existence of an unmet need and a significant market opportunity.
Skillington said the research confirmed a strong and clearly defined value proposition across payers. He noted that CRS occurs in many CAR-T and bispecific antibody treatments and that it is not possible to predict who will develop CRS or how severe it will be.
He said when CRS develops, treatment often has to be delayed or stopped, which can affect patient outcomes while increasing hospital stays and costs. The company said insurers recognized this cost burden and assessed what they would be willing to pay to prevent CRS.
According to Skillington, the findings highlighted pricing levels and indicated that POLB 001 has multi-billion-dollar peak sales potential in the US. He said the results strengthen the company’s position ahead of anticipated clinical data and future partnership discussions.
Poolbeg Pharma said it expects positive clinical trial data as recruitment progresses, with partnership discussions likely to advance alongside the release of interim results later this summer.
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