Positive Initial Data Analysis in POLB 001 Trial

Poolbeg Pharma

09/01/2023 07:00

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RNS Number : 0094M  Poolbeg Pharma PLC  09 January 2023

Poolbeg Pharma Plc

 

Positive Initial Data Analysis in POLB 001 LPS Challenge Trial

 

Early data read out indicates a successful LPS human challenge trial

Key Highlights

·      POLB 001 demonstrated a marked reduction in both systemic and
localised inflammatory response compared to volunteers who received placebo

·      A clear dose-response relationship was
demonstrated
 

·      Well tolerated across all doses and no serious adverse events or
volunteer withdrawals were reported

·      Full data read-out expected in Q2 2023 following a final quality
check of the unblinded data

9 January 2023 - Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, 'Poolbeg' or the
'Company'), a leading infectious disease focused biopharmaceutical company,
announces positive initial data analysis for POLB 001, a viral strain
agnostic, small molecule immunomodulator being developed to address the
significant unmet medical need for severe influenza.

 

As announced in December, full data read-out is expected in Q2 2023. However,
upon initial review, the data indicates that administration of POLB 001
resulted in a marked reduction in both systemic and localised inflammatory
response in subjects challenged with bacterial lipopolysaccharide ("LPS")
compared to those who received placebo. A clear dose-response relationship was
also apparent. This LPS challenge trial was designed to evaluate the effect of
POLB 001 on inflammatory responses in 36 healthy volunteers between 18 and 55
years of age following both an intradermal and an intravenous LPS challenge.
LPS acts as a surrogate for the hyperinflammatory response associated with
severe influenza and other diseases. POLB 001 was well tolerated across all
doses and no serious adverse events or volunteer withdrawals were reported.

 

Jeremy Skillington, CEO of Poolbeg Pharma, said: "Following the completion of
the LPS human challenge trial in December, we are excited to see this positive
initial data of POLB 001. The clear anti-inflammatory dose response, with no
serious adverse events, further demonstrates the strong potential for POLB 001
to address the significant unmet medical need in severe influenza and beyond.
We look forward to presenting the full data in Q2 2023.

 

We are delighted to have completed our first clinical trial on schedule,
delivering on our business model of rapidly generating early human clinical
data. We believe that the positive initial data is a significant value
inflection point and will support discussions with partners."

 

About POLB 001

POLB 001 is a small molecule immunomodulator for the treatment of
hypercytokinemia related diseases such as severe influenza. POLB
001 electively inhibits overwhelming inflammation in viral infections, such
as influenza, while leaving the necessary immune functions intact to fight the
infection. This contrasts with other immunomodulatory approaches, such as
steroids, which affect both beneficial and damaging immune responses. Due to
its mode of action it is strain agnostic and unaffected by seasonal variants
which is a significant advantage over treatments available on the market. In
addition, as a shelf stable oral drug it is an ideal stock piling candidate
for both seasonal and pandemic outbreaks. Therefore, POLB 001 has the
potential to be a transformational treatment for patients and to become a
leading severe influenza treatment.

 

Virtual Company presentation

 

Jeremy Skillington, PhD, Chief Executive Officer, and Professor Brendan
Buckley, Scientific Advisory Board member, will provide a live presentation
via the Investor Meet Company platform on Monday 16 January 2023
at 5:30pm. Click here to register
(https://www.investormeetcompany.com/poolbeg-pharma-plc/register-investor) .

 

The presentation is open to all existing and potential shareholders. Investors
can sign up to Investor Meet Company for free and add to meet Poolbeg
Pharma plc here
(https://www.investormeetcompany.com/poolbeg-pharma-plc/register-investor) .
The presentation and recording will be available on the Company's website
after the event here
(https://www.poolbegpharma.com/investors/events-presentations/) .

 

- Ends -

Enquiries

 Poolbeg Pharma Plc                                                +44 (0) 207 183 1499

 Jeremy Skillington, CEO

 Ian O'Connell, CFO

 finnCap Ltd (Nominated Adviser & Joint Broker)                    +44 (0) 207 220 0500

 Geoff Nash, Charlie Beeson, Nigel Birks, Harriet Ward (ECM)

 Singer Capital Markets (Joint Broker)                              +44 (0) 207 496 3000

 Phil Davies, Sam Butcher

 J&E Davy (Joint Broker)                                           +353 (0) 1 679 6363

 Anthony Farrell, Niall Gilchrist

 Optimum Strategic Communications                                  +44 (0) 208 078 4357

 Mary Clark, Nick Bastin, Vici Rabbetts                            poolbeg@optimumcomms.com (mailto:poolbeg@optimumcomms.com)

 

About Poolbeg Pharma

 

Poolbeg Pharma specialises in the development of innovative medicines to
address the unmet need in prevalent and emerging infectious diseases. Poolbeg
has a disciplined portfolio approach to mitigate risk, accelerate drug
development and enhance investor returns. The Company simultaneously advances
multiple programmes in cost-effective clinical trials, rapidly generating
early human safety and efficacy data to enable early partnering /
out-licensing, with the funds generated reinvested in the pipeline. Poolbeg
also uses AI to interrogate human challenge trial data sets to quickly
identify new targets and drugs, and in-license near or in the clinic
medicines, leading to faster development and greater commercial appeal.

 

The Company is targeting the growing infectious disease market. In the wake of
the COVID-19 pandemic, infectious disease has become one of the fastest
growing pharma markets and is expected to exceed $250bn by 2025.

 

With its initial assets from hVIVO plc (http://www.hvivo.com)
 (formerly Open Orphan plc), an industry leading infectious disease and
human challenge trials business, Poolbeg has access to knowledge, experience,
and clinical data from over 20 years of human challenge trials. The Company is
using these insights to acquire new assets as well as reposition clinical
stage products, reducing spend and risk. Amongst its portfolio of exciting
assets, Poolbeg has a small molecule immunomodulator for severe influenza
(POLB 001) in which initial data analysis indicates a marked reduction in both
systemic and localised inflammatory response in an LPS human challenge trial
(full data read-out expected in Q2 2023); a first-in-class, intranasally
administered RNA-based immunotherapy for respiratory virus infections (POLB
002); and a vaccine candidate for Melioidosis (POLB 003). The Company is also
developing two Oral Delivery Programmes and is progressing
two Artificial Intelligence (AI) Programmes to add promising new assets to
its pipeline.

 

For more information, please go to www.poolbegpharma.com
(http://www.poolbegpharma.com/)  or follow us on Twitter
(https://twitter.com/PoolbegPharma)  and LinkedIn
(https://www.linkedin.com/company/poolbeg-pharma/)  @PoolbegPharma.

 

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