REG - Poolbeg Pharma PLC - POLB 001 LPS Challenge Trial Paper Published

Poolbeg PharmaAnnouncement

Today 07:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20260128:nRSb6274Qa&default-theme=true

RNS Number : 6274Q  Poolbeg Pharma PLC  28 January 2026

 

Poolbeg Pharma plc

 

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

 

28 January 2026- Poolbeg Pharma (https://www.poolbegpharma.com/)  (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:

 

 ·                     POLB 001 significantly reduced key inflammatory biomarkers and immune cell
                       recruitment following LPS challenge in healthy volunteers
 ·                     POLB 001 was safe and well tolerated across all dose levels
 ·                     Study confirms POLB 001 potently inhibits p38 MAPK driven cytokine responses
 ·                     Publication endorses significant potential of POLB 001 with the interim data
                       anticipated from the TOPICAL trial
                       (https://polaris.brighterir.com/public/poolbeg_pharma/news/rns/story/x409mow)
                       this summer

 

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
(https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2025.1684307/full)
, DOI: https://doi.org/10.3389/fimmu.2025.1684307
(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:

 

 ·                     The suppression of immune cell recruitment was most pronounced in neutrophils
                       (72.4%-81.5%, p = 0.0091), classical monocytes (68.4%-73.6%, p = 0.0036), CD3+
                       T cells (56.4%-65.9%, p = 0.0047), and myeloid dendritic cells (59%-64.4%, p =
                       0.0174).
 ·                     The suppression of cytokine responses was most pronounced for TNF
                       (35.3%-65.1%, p = 0.0099).
 ·                     Overall, POLB 001 did not substantially modulate the intradermal LPS-driven
                       increase in local erythema and perfusion.
 ·                     POLB 001 significantly reduced the IV LPS-driven increase in IL-6, IL-8, and
                       TNF (37.7%-80.7%, all p < 0.0003), p38 MAPK phosphorylation levels in
                       target cells (16.7%-60.9%, all p < 0.0001), and heart rate increase (4-9.3
                       bpm, p < 0.0001).

 

As previously announced
(https://polaris.brighterir.com/public/poolbeg_pharma/news/rns/story/x5zok8x)
, 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."

 

 

Enquiries

 

 Poolbeg Pharma Plc                                            +44 (0) 207 183 1499

 Jeremy Skillington, CEO                                       ir@poolbegpharma.com (mailto:ir@poolbegpharma.com)

 Ian O'Connell, CFO

  
 Cavendish Capital Markets Ltd (NOMAD & Joint Broker)          +44 (0) 207 220 0500

 Geoff Nash, Trisyia Jamaludin (Corporate Finance)

 Nigel Birks (Life Science Specialist Sales)

 Harriet Ward (ECM)

  
 Shore Capital Stockbrokers Ltd (Joint Broker)                 +44 (0) 207 408 4090

 David Coaten, Harry Davies-Ball (Corporate Advisory)

Malachy McEntyre (Corporate Broking)
 J&E Davy (Joint Broker)                                       +353 (0) 1 679 6363

 Anthony Farrell, Niall Gilchrist

  
 Optimum Strategic Communications                              +44 (0) 208 078 4357

 Nick Bastin, Vici Rabbetts, Elena Bates                       poolbeg@optimumcomms.com (mailto:poolbeg@optimumcomms.com)

  

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.

 

Stay updated: Website (http://www.poolbegpharma.com) | Sign up for RNS
alerts
(https://www.poolbegpharma.com/investors/regulatory-news-email-alerts/#email-alerts)
| Presentation
(https://www.poolbegpharma.com/investors/events-presentations/)  | X
(https://x.com/PoolbegPharma)  | LinkedIn
(https://www.linkedin.com/company/poolbeg-pharma/)

 

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.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCAKOBKKBKBPDB



            Copyright 2019 Regulatory News Service, all rights reserved