Poolbeg Pharma plc - Peer-Reviewed POLB 001 LPS Challenge Trial Paper Published in Frontiers in Immunology

Poolbeg Pharma plc - Peer-Reviewed POLB 001 LPS Challenge Trial Paper Published in Frontiers in Immunology

28 January 2026- Poolbeg Pharma (AIM: POLB, 'Poolbeg' or the 'Company'), a clinical-stage biopharmaceutical company with a core focus on transforming the cancer immunotherapy field, announces the publication of a peer-reviewed paper from the POLB 001 LPS human challenge trial in Frontiers in Immunology. Key conclusions from the paper include:

The paper entitled, “POLB 001, a p38 MAPK inhibitor, decreases local and systemic inflammatory responses following in vivo LPS administration in healthy volunteers: a randomised, double-blind, placebo-controlled study” by Digna T. de Bruin, et al is available in Frontiers in Immunology, DOI: https://doi.org/10.3389/fimmu.2025.1684307

The bacterial lipopolysaccharide (“LPS”) challenge trial was a randomised, double-blind, placebo-controlled study, examining POLB 001’s ability to suppress both local and systematic inflammatory responses in healthy volunteers. Key findings include:

As previously announced, the trial demonstrated that POLB 001 was safe and well-tolerated, with a clear dose-response relationship, inhibition of p38 MAPK activation, and reduction in all measured pro-inflammatory cytokines. The results agree with previous observations that POLB 001 has the potential to prevent an excessive immune response without ablating normal immune function. 

The findings provide strong validation of POLB 001’s method of action and supports its progression towards further clinical development. The publication further strengthens the rationale for POLB 001 as a potential solution for the prevention of cancer immunotherapy-induced Cytokine Release Syndrome (“CRS”).

POLB 001 to prevent CRS

The Directors believe that POLB 001 has the potential to transform the cancer immunotherapy field by expanding administration from centralised specialist cancer centres into community hospitals by making the treatments safer through the prevention of CRS, a potentially life-threatening side effect. As such, POLB 001 could make these treatments more accessible to a broader patient population, increase the number of patients that can receive these life-saving treatments, and reduce the burden on healthcare systems.

Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said: “The publication of peer-reviewed clinical data from our LPS challenge trial in Frontiers in Immunology is an important milestone for Poolbeg. 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.”  

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About Poolbeg Pharma plc 

Poolbeg Pharma plc (AIM: POLB) is a clinical-stage biopharmaceutical company with a core focus on transforming the cancer immunotherapy field. The Company’s lead asset, POLB 001, has the potential to expand administration of cancer immunotherapies from centralised specialist cancer centres into community hospitals by making the treatments safer through the prevention of the life-threatening side effect, Cytokine Release Syndrome (CRS). As such, POLB 001 could increase the number of patients that can receive these life-saving treatments, thereby increasing the market opportunity. Poolbeg is also advancing the development of a patient-friendly therapy for obesity with an oral encapsulated GLP-1, offering a differentiated approach within one of the world’s largest markets. With multiple near-term clinical value inflection points, and an experienced team with a proven track record, Poolbeg is focussed on partnering its high value programmes that are targeting large markets and addressing critical unmet medical needs. 

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Forward-Looking Statements

This announcement may contain forward-looking statements and the words "expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast", "project" and similar expressions (or their negative) identify certain of these forward-looking statements. The forward-looking statements in this announcement are based on numerous assumptions and Poolbeg's present and future business strategies and the environment in which Poolbeg expects to operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These statements are not guarantees of future performance or the ability to identify and consummate investments. Many of these risks and uncertainties relate to factors that are beyond Poolbeg's ability to control or estimate precisely, such as future market conditions, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Poolbeg's ability to obtain financing, changes in the political, social and regulatory framework in which Poolbeg operates or in economic, technological or consumer trends or conditions. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information.