Poolbeg Pharma plc

POLB 001 Clinical Development - Clinical Trial Agreement Signed

On track to commence LPS human challenge clinical trial in June 2022

31 March, 2022 - Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, 'Poolbeg' or the 'Company') announces that it has signed a Clinical Trial Agreement with the Centre for Human Drug Research (CHDR) in the Netherlands for the completion of a bacterial lipopolysaccharide ('LPS') human challenge study of POLB 001, which is due to commence in June 2022. First results are expected before the end of 2022 at which point the Company aims to rapidly monetise by partnering or out licensing the asset to pharma / biotech for further development.

As part of this study, which is being completed in line with the Company's capital light approach, researchers will stimulate the immune systems of healthy volunteers with LPS in a safe and controlled clinical environment. LPS emulates a robust immune response acting as a simulant for the hyperinflammatory effects associated with severe influenza infections which CHDR will use to measure the efficacy of POLB 001 as its mode of action is to block this hyper-immune response. This differs from existing treatments because it targets the host immune response rather than the virus itself and is therefore unaffected by viral variance. Poolbeg has defined and formulated the oral administration of POLB 001 and already has sufficient grade and quantities of the drug to utilise immediately in the forthcoming human challenge study.

In the study the LPS will be administered both intradermally (a shallow injection) and intravenously (an injection of a vein). By administering the LPS intradermally, the Company can gather data around the localised response of the body to POLB 001. By then administering the LPS intravenously, data can be gathered around the full body systemic response to POLB 001. By using both methods within one study, the Company will efficiently and cost effectively collect both local and systemic efficacy data, increasing the value of the data package which will be attractive to potential partners. Overall, the study will generate key human data on the efficacy of POLB 001 in dampening the immune response in otherwise healthy volunteers.

Jeremy Skillington, PhD, CEO of Poolbeg Pharma said:

"We are moving forward at a strong pace to enable the upcoming human challenge clinical trial of POLB 001 to commence as planned. This study will provide invaluable early human data on the efficacy of this asset in dampening the immune response after being stimulated, thereby limiting the damage it can otherwise cause in a setting such as severe influenza.

We will continue to provide updates as we progress towards commencing the study in June 2022 with results due before the end of the year. We are looking forward to receiving the broad spectrum of data from this study, given that it will be completed both intradermally and intravenously, thus maximizing the data package that can be shared with any potential pharma or biotech licensing partner."

More Information on influenza and POLB 001

The threat of influenza is significant, with cases at their highest globally since the COVID-19 pandemic. Influenza affects 1 in 8 of the global population and causes 500,000 deaths each year. In cases of severe influenza, the body produces an over-heightened immune response that can cause more damage to the body than the virus itself.

POLB 001 was identified using the unique disease progression data available from human challenge trials. Data from human challenge studies are unique in that they track a healthy subject through disease to recovery in carefully controlled and monitored isolation units, collecting samples throughout the course of disease, and vitally collecting matched baseline and follow-up samples before and after infection. By mapping the entire biological process of disease, it provides a platform to help identify promising disease relevant pathways in the pursuit of novel drug targets. The Company is now progressing two artificial intelligence programmes to complete analysis of influenza and Respiratory Syncytial Virus (RSV) data faster and more cost effectively than previously possible.

*Good Manufacturing Practice (GMP) is the regulatory code of standards that a medicine's manufacturer must meet in its production processes to enable administration to humans.

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (as implemented into English law) ("MAR"). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

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About Poolbeg Pharma

Poolbeg Pharma is a clinical stage infectious disease pharmaceutical company, with a capital light clinical model which aims to develop multiple products faster and more cost effectively than the conventional biotech model. The Company, headquartered in London, is led by a team with a track record of creation and delivery of shareholder value and aspires to become a "one-stop shop" for Big Pharma seeking mid-stage products to license or acquire.

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 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); a first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections (POLB 002); and a vaccine for Melioidosis (POLB 003). The Company is also developing an oral vaccine delivery platform and is progressing two artificial intelligence (AI) drug discovery programmes to accelerate the power of its human challenge model data and biobank.

For more information, visit www.poolbegpharma.com or follow us @PoolbegPharma