REG - Poolbeg Pharma PLC - MHRA grants CTA for the POLB 001 TOPICAL trial

Poolbeg PharmaAnnouncement

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RNS Number : 4783A  Poolbeg Pharma PLC  15 April 2026

 

Poolbeg Pharma plc

 

MHRA grants Clinical Trial Authorisation for the TOPICAL trial and independent
research confirms significant commercial opportunity for POLB 001

 

Trial on track to deliver interim data this summer

 

15 April 2026- Poolbeg Pharma
(https://protect.checkpoint.com/v2/r02/___https:/www.poolbegpharma.com/___.YXAxZTpzaG9yZWNhcDpjOm86MmI2OWFmYmU2ZGVmOGFmMjRjZjIwYTZhMWI0YzUzOTI6Nzo2M2Q2OjY1YTk2ZTY1YWRmZjg0ODYzZmE1YmExZmY4OTc5NjgwNzMxMTZlYjlhZmI1YzRhMzdhZjYyODA5YWE1NDFkNTU6cDpGOk4)
 (AIM: POLB, 'Poolbeg' or the 'Company'), a clinical-stage biopharmaceutical
company with a core focus on transforming the cancer immunotherapy field,
announces that the UK Medicines and Healthcare products Regulatory Agency
("MHRA") has granted Clinical Trial Authorisation ("CTA") for the POLB 001
TOPICAL trial. With all required regulatory clearances now in place and site
initiation visits scheduled, the trial remains on track to deliver interim
data this summer.

 

The Company also announces positive findings from new independent US focused
payer research conducted by Acumetis Global indicates multi-billion-dollar
peak sales potential in the United States.

 

POLB 001 on track to deliver interim data this summer

 

POLB 001 is being developed as a potential first approved preventative therapy
for cancer immunotherapy-induced Cytokine Release Syndrome ("CRS"). The
TOPICAL trial will investigate POLB 001 in approximately 30
relapsed/refractory multiple myeloma patients receiving the approved
bispecific antibody teclistamab, which has been supplied by Johnson &
Johnson at no cost to Poolbeg.

 

The study now spans six sites across the UK, with NHS Lothian in Edinburgh and
the Royal Stoke University Hospital joining existing sites at the NHS Trusts
at The Christie, The Royal Marsden, University College London Hospitals, and
University Hospitals Birmingham. Site initiation visits are scheduled with
patient screening set to commence shortly.

 

Unlike many oncology studies, given that CRS is an acute condition which
occurs within days or weeks of initiation of a bispecific antibody, the design
of the TOPICAL trial will allow rapid read out.

 

Independent US payer research reconfirms compelling commercial opportunity

 

The research, which engaged current payers covering approximately 75 million
lives across a mix of commercial insurance providers, Medicare and Medicaid,
confirms the strong, clearly defined value proposition for POLB 001. In
particular, findings underscore POLB 001's potential to play an important role
in the management of CRS by reducing the significant hospital costs associated
with the condition and enabling a meaningful shift in care away from
specialist centres of excellence toward outpatient and community settings.

 

The report also noted that CRS occurs in the majority of CAR T and bispecific
antibody treatments, with no established diagnostic method currently available
to predict either the likelihood or severity of CRS in individual patients.
Dosing of bispecific antibodies must be withheld until CRS resolves, often
delaying patients from achieving therapeutically effective dosing levels and
prolonging hospitalisation, while those who experience high-grade CRS must
permanently discontinue treatment, meaning that these patients can no longer
receive the potentially life-saving treatment.

 

The research reconfirmed the significant cost burden associated with managing
CRS and that an effective preventative treatment would represent a compelling
value proposition for healthcare systems.

 

The findings highlight pricing levels that demonstrate POLB 001's
multi-billion-dollar peak sales potential, providing increased confidence in
the Company's anticipated market opportunity and further supports POLB 001's
future value and appeal to potential partners.

 

Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg Pharma, said: "We
have made excellent progress on the TOPICAL clinical trial, with all
regulatory approvals now received, additional trial sites added to the study,
and site initiation visits scheduled, we are on track to achieve interim data
this summer. We believe POLB 001 has the potential to transform the cancer
immunotherapy field through the prevention of CRS, improving patient quality
of life and expanding the number of patients that can receive these
life-saving cancer immunotherapies.

 

"In addition, the findings from the independent research report offer
important external validation of both the clinical relevance and commercial
opportunity of POLB 001. The clear willingness for payers to address the
significant burden associated with CRS, reinforces our confidence in POLB
001's ability to deliver meaningful value to healthcare systems and its
potential to achieve multi-billion-dollar peak sales in the US."

 

Chris Grimes Crompton, Partner, Value Strategy, Acumetis Global said: "We
interviewed payers across the commercial insurance, Medicare and Medicaid
landscape to explore the burden of CRS and their attitudes towards novel
treatment approaches. The research confirmed that CRS represents a significant
and costly challenge in the cancer immunotherapy field as well as limiting the
utilisation of new immunotherapy treatments due to the requirement for
specialised centres to administer care.

 

"This research validates both the scale of that unmet need and the appetite
among payers for an effective preventative approach. We observed a willingness
to pay at commercially meaningful price points, driven by the potential to
reduce hospitalisation costs, potentially allowing for care to be
decentralised and ultimately delivering better outcomes for some of the
sickest patients. This positions POLB 001 as a compelling CRS solution with
significant market potential."

 

 

*TOPICAL: Trial of Prevention of ImmunoCytokine Adverse events in Myeloma.

 

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.

 

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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.

 

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