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Poolbeg ready to commence POLB 001 clinical study

Last updated: 09:24 20 Jul 2022 BST, First published: 09:21 20 Jul 2022 BST

Poolbeg Pharma is to commence a human challenge trial for its lead molecule POLB 001, a small molecule immunomodulator intended for the treatment of severe influenza, marking delivery against an important commitment made in its IPO a year ago. The company has received ethics and competent authority approval for the study and expects to carry out the formal site initiation visit later this week. The study will be conducted at the CHDR, an independent institute in the Netherlands specialising in early clinical trials.

The study will test POLB 001, an in-licensed p38 MAPK inhibitor, in a condition that mimics the hyper-inflammatory response (cytokine storm) that can occur in influenza. The study will be conducted in healthy volunteers, where the symptoms are triggered by exposure to LPS (lipopolysaccharide), a cell surface molecule produced by most Gram-negative bacteria.

Thestudy is randomised, double-blind and placebo-controlled and tests multiple doses in 36 healthy volunteers challenged with LPS administered both intradermally and intravenously. There will be three cohorts with escalating dose (30mg, 70mg, 150mg), with 12 volunteers per treatment group (3:1 drug: placebo) with the study drug administered orally, twice daily for seven consecutive days.

The endpoints are as follows: for intradermal (skin response by imaging, blister exudate analysis, skin punch biopsy, safety and tolerability) and for IV are bloods (cytokines, vascular markers, CRP), ex-vivo LPS response and safety & tolerability (including vital signs, AEs, ECG and haematology). It is hoped the study will show a dose-dependent reduction in the inflammatory response.

Initial results are expected before the end of 2022, after which Poolbeg aims to secure a licensing deal for the further development of POLB 001. The company expects that this study, when combined with data from earlier studies conducted by a prior licensor, will provide a broad data package that should be attractive to potential partners. The company is exploring further disease indications and the results from this study could provide insights in these indications.

 

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