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 (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.

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. The presentation and recording will be available on the Company's website after the event here.

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."

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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."

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Enquiries

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 (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 or follow us on Twitter and LinkedIn @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 2000m² state of the art facility in Cork, comprising R&D laboratories, pilot plant and production facilities

For further information email aidan.fitzsimons@anabio.ie