Poolbeg Pharma PLC (AIM:POLB, OTC:POLBF, FRA:POLBF) told investors that a peer-reviewed paper from its POLB 001 LPS human challenge trial has been published in Frontiers in Immunology.
The company said the publication reports that POLB 001 significantly reduced key inflammatory biomarkers and immune cell recruitment following LPS challenge in healthy volunteers and was safe and well tolerated across all dose levels.
Poolbeg said the randomised, double-blind, placebo-controlled study evaluated POLB 001’s ability to suppress local and systemic inflammatory responses.
The company highlighted reductions in immune cell recruitment including neutrophils (72.4% to 81.5%, p = 0.0091) and classical monocytes (68.4% to 73.6%, p = 0.0036), alongside suppression of cytokine responses including TNF (35.3% to 65.1%, p = 0.0099).
Poolbeg also reported that POLB 001 significantly reduced IV LPS-driven increases in IL-6, IL-8 and TNF (37.7% to 80.7%, all p < 0.0003), p38 MAPK phosphorylation levels in target cells (16.7% to 60.9%, all p < 0.0001), and heart rate increase (4 to 9.3 bpm, p < 0.0001).
“The publication of peer-reviewed clinical data from our LPS challenge trial in Frontiers in Immunology is an important milestone for Poolbeg," said chief executive Jeremy Skillington.
"The positive data from this trial highlights that oral treatment of POLB 001 holds great promise in addressing cancer immunotherapy-induced CRS and supports further clinical development of the asset, including the POLB 001 TOPICAL clinical trial."
The company said the publication supports the rationale for POLB 001 as a potential approach to preventing cancer immunotherapy-induced Cytokine Release Syndrome, and noted interim data is anticipated from the TOPICAL trial this summer.