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Metabolic diseases oral delivery licence signed

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RNS Number : 6634J  Poolbeg Pharma PLC  14 December 2022

Poolbeg Pharma plc

 

Poolbeg exclusively licences innovative oral delivery technology for metabolic
syndrome related diseases

 

Clinical trial to demonstrate technology can safely deliver GLP-1 to commence
in H1 2023

Prof Brendan Buckley joins Poolbeg's Scientific Advisory Board to guide
clinical development of technology

Licence expands Poolbeg's existing exclusive licence to AnaBio's oral vaccine
delivery technology

Investor Meet Company presentation on 14 December 2022 at 5:30pm

 

Poolbeg Pharma
(https://eur02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.poolbegpharma.com%2F&data=05%7C01%7CCarol.Dalton%40poolbegpharma.com%7Cff25a2964da5486503be08dad7df228e%7C3d00da7edd9841608844c86c632311aa%7C1%7C0%7C638059650609179274%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=gvbEQ1lg%2Fe8QzsysOLuiRyJdxaiMK%2BXEiSwaJvVji3Q%3D&reserved=0)
(AIM: POLB, OTCQB: POLBF, 'Poolbeg' or the 'Company'), a leading infectious
disease focused biopharmaceutical company, announces that it has acquired an
exclusive licence from InsuCaps Limited ("InsuCaps"), a sister company of
AnaBio Technologies ("AnaBio"), to use InsuCaps' patented microencapsulation
and nanoencapsulation oral delivery technologies in metabolic syndrome related
diseases including  obesity, pre-diabetes and diabetes. Obesity alone costs
the US healthcare system c. $173bn a year.

 

Following the licence, in H1 2023 Poolbeg will rapidly commence a
proof-of-technology clinical trial to determine that a Glucagon-like Peptide 1
receptor (GLP-1) agonist can be safely delivered orally in humans. GLP-1
agonists, which are used to treat diabetes and obesity, represent an extremely
large, fast-growing opportunity estimated to grow to c.$22bn per annum by
2025. At present, all but one GLP-1 products are injectables, which are more
onerous for patients than oral delivery.

 

The upcoming trial is designed to provide data confirming that the patented
microencapsulation and nanoencapsulation technologies can safely deliver GLP-1
orally, with results expected to be announced later next year. In line with
its rapid-partnering model, Poolbeg then intends to licence the technology to
pharma and biotech for use in obesity and / or diabetes, as well as other
active molecules in metabolic syndrome related diseases.

 

This oral GLP-1clinical trial rapidly follows the completion of Poolbeg's LPS
challenge trial for POLB 001 and, like the LPS challenge study, is in line
with Poolbeg's efficient, capital light approach to clinical development at
the core of the Poolbeg model.

 

This exclusive licence is in addition to Poolbeg's exclusive license to
AnaBio's microencapsulation and nanoencapsulation technologies which underpins
Poolbeg's Oral Vaccine Platform. As recently announced, a Poolbeg-led
consortium was awarded €2.3m in non-dilutive funding by the Irish
Government's Disruptive Technologies Innovation Fund to progress the Oral
Vaccine Platform.

 

Addition to Poolbeg's Scientific Advisory Board

 

Poolbeg has also added Prof Brendan Buckley to its Scientific Advisory Board.
He is the former Chief Medical Officer at ICON plc, a medical graduate of
University College Cork and a doctoral graduate in Biochemistry in the Faculty
of Medicine at Oxford University. Prof Buckley has advised Poolbeg since
inception and has deep experience in metabolic diseases including over 40
years' experience in clinical practice as a Consultant Physician in
endocrinology, diabetes and in academic clinical pharmacology. In addition,
Brendan has sat on the European Medical Agency (EMA)'s Scientific Advisory
Group for Diabetes and Endocrinology. He has published over 150 scientific
papers, mainly on metabolic disease, as well as the recent key opinion-leading
book 'Re-Engineering Clinical Trials'.

 

Investor Meet Company presentation - 14 December 2022 at 5:30pm

 

Jeremy Skillington, PhD, Chief Executive Officer, and Professor Brendan
Buckley will provide a live presentation via the Investor Meet
Company platform on 14 December 2022 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/) .

 

Jeremy Skillington, PhD, CEO of Poolbeg Pharma said: "Poolbeg saw the
potential for microencapsulation and nanoencapsulation oral delivery
technologies in vaccines, and this has been further validated by the grant
from the Irish Government's Disruptive Technologies Innovation Fund. Drawing
on our growing understanding of this technology from our Oral Vaccine
Platform, we believe that there is significant opportunity in other adjacent
areas, such as metabolic diseases. Diabetes and obesity are extremely fast
growing markets and the ability to administer drugs orally, rather than
through injection, will improve access and quality of life for millions of
patients. We are really excited to be moving swiftly to a proof-of-concept
trial in H1 2023 to test the oral delivery of GLP-1 in humans, with the
results to be announced later in the year."

---

Dr Sinéad Bleiel, Founder & Chief Scientific Officer of InsuCaps said:
"We are excited to be expanding our working relationship with Poolbeg and
believe that the trial commencing in H1 2023 will deliver meaningful data
showing our ability to orally deliver GLP-1 safely and efficiently. As the
world is beginning to realise, GLP-1 and similar metabolic peptides have life
changing effects for diabetics and are becoming the obesity management drug of
choice for the years ahead. We believe that our microencapsulation and
nanoencapsulation oral delivery technologies can potentially deliver
significant quality of life benefits to patients suffering from these
long-term metabolic syndrome conditions."

 

-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, Manel Mateus, 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 (https://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) which has
completed its LPS human challenge trial with 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 accelerate the power of its human challenge model data and biobank, with
results from the first programme expected by year end.

 

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.

 

About Insucaps

 

InsuCaps is a specialist microencapsulation company, focussed on improving
health and performance through micro-encapsulation of Active Pharmaceutical
Ingredients for pharmaceutical applications.

 

Microencapsulation represents a sophisticated delivery system whereby a
protective coat is created at microscopic level around the API which protects
it from a wide range of environmental conditions, enables its release at the
appropriate site within the body, and thereby ensures that the health benefits
of the API are fully realised. InsuCaps has successfully applied this
technology for the oral delivery of injectable API's, ensuring protection
during tabletting and similar processing, maintaining the API stability
through the hostile environment of the stomach and ensuring its successful
transfer across the gut wall to deliver the associated biological effect. The
technology is protected via 16 patent families.

 

InsuCaps operates out of a 2000m(2) state of the art facility in Cork,
comprising R&D laboratories, pilot plant and production facilities

 

For further information email aidan.fitzsimons@anabio.ie
(mailto:aidan.fitzsimons@anabio.ie)

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