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Positive Results POLB001 LPS Human Challenge Trial
Positive Results POLB001 LPS Human Challenge Trial.
About this update from Poolbeg Pharma Plc
[{"type":"text","content":"\n \n \n \n Poolbeg Pharma Plc\n \n \n \n \n \n \n \n \n \n Positive Results from POLB 001 LPS Human Challenge Trial\n \n \n \n \n Strong potential for POLB 001 to be a blockbuster treatment for severe influenza\n \n \n \n \n Key Highlights\n \n \n \n ·\n \n POLB 001 resulted in a highly significant reduction in p38 MAP kinase driven cytokines\n \n \n \n ·\n \n POLB 001 treatment exhibited a marked reduction in multiple markers of systemic and local inflammation compared with placebo\n \n \n \n ·\n \n Trial results demonstrate expected utility in severe influenza and other acute inflammatory conditions\n \n \n \n \n 2 March 2023 -\n \n Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, 'Poolbeg' or the 'Company'), a leading infectious disease focused biopharmaceutical company, announces the data readout from the bacterial lipopolysaccharide ('LPS') human challenge trial for POLB 001, a viral strain agnostic, small molecule immunomodulator being developed to address the unmet medical need arising from severe influenza and other acute inflammatory conditions. POLB 001 was shown to be safe and well tolerated and had a potent effect in systemic and localised inflammatory response in a dose dependent manner.\n \n \n \n \n \n \n About the LPS Challenge Trial\n \n \n \n A total of 36 healthy volunteers aged 18 to 55 were enrolled and completed the trial. Subjects treated with POLB 001 exhibited a marked reduction in multiple markers of systemic and localised inflammation compared with placebo. p38 MAPK target engagement within circulating blood cells caused a substantial ablation of blood cytokines which are synonymous with cytokine release syndrome ('CRS') common in severe influenza, patients receiving CAR T cell treatment and other acute inflammatory conditions.\n \n \n \n \n \n \n Systemic Inflammatory Response\n \n \n \n The typical LPS-induced rise in plasma cytokine levels (TNF-α, IL-6, and IL-8) decreased between 57-81% across all cytokines in subjects treated with 70 mg or 150 mg POLB 001 (all highly significant P values <0.0003).\n \n \n \n \n \n \n \n POLB 001 was shown to have the following dose dependent effects:\n \n \n - \n blunted the LPS associated rise in heart rate across all dose groups (P<0.001)\n \n \n - reduced body temperature and C-reactive protein ('CRP') levels, a clinically used...