Poolbeg Pharma (AIM:POLB) reported unaudited interim results for the six months to 30 June, and highlighted that eight of approximately 30 participants have now been dosed in its TOPICAL trial.
The Dublin-based clinical-stage biopharmaceutical company is developing POLB 001, a p38 MAPK inhibitor, to prevent cytokine release syndrome (CRS), a toxic side effect of cancer immunotherapy.
As a pre-revenue developer, Poolbeg's financial metrics are secondary to trial and regulatory progress; the company said the TOPICAL trial began following MHRA clinical trial authorisation, with recruitment activity described as encouraging across investigators, centres and patients.
Poolbeg said a positive FDA pre-IND meeting aligned regulators on POLB 001's development pathway and future Phase 3 primary endpoint, while independent US payer research covering roughly 75 million lives found willingness to pay at commercially meaningful price points, supporting what the company calls multi-billion-dollar US peak sales potential.
The company's cancer immunotherapy-induced CRS patent family has now been granted in Canada, Australia and Europe and allowed in Israel, building on the patent grants and allowances reported through the year.
Post-period, the TOPICAL trial was recommended to continue unchanged after a positive review of the six-patient interim safety cohort.
"With both clinical programmes funded through to completion, we believe Poolbeg is well positioned for its next phase of value creation," said chief executive Jeremy Skillington.
The company completed a £3.5 million placing in July, extending its cash runway into the second quarter of 2028 and funding both the TOPICAL trial and a planned Oral GLP-1 proof-of-concept study at the University of Ulster.