Poolbeg Pharma plc

Successful Artificial Intelligence led programme identifies multiple influenza drug targets

AI analysis of unique human challenge trial data provides unparalleled insights into influenza infection

Novel influenza drug targets identified faster and more cost-effectively using AI

29 June 2023 - Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, 'Poolbeg' or the 'Company'), a clinical-stage biopharmaceutical company focusing on infectious and other prevalent diseases with a high unmet medical need, announces a significant breakthrough in its world first influenza Artificial Intelligence ('AI') Programme with CytoReason. Poolbeg has been working with CytoReason since March 2022.

Poolbeg's unique disease progression data from influenza human challenge trials combined with CytoReason's broad repositories of curated disease data were analysed using CytoReason's industry-leading AI-led platform. The analysis has led to the discovery of multiple novel drug targets for the treatment of influenza.

Identification of drug targets from this unique data-set has previously been successful as p38 MAP Kinase, inhibited by POLB 001, was identified as a driver of severe influenza but this required manual analysis that took several years. However, through the utilisation of CytoReason's cutting-edge AI technology, Poolbeg has now identified multiple novel drug targets in just 15 months. Moreover, CytoReason's analysis independently confirmed the significance of the p38 MAP kinase pathway in influenza, providing further validation for Poolbeg's POLB 001 programme.

The Company is actively exploring the most effective way to further develop the novel drug targets in order to generate value and looks forward to updating shareholders about the progress of this programme in due course. This marks Poolbeg's second successful AI Programme, following the identification of potential new drug candidates for Respiratory Syncytial Virus (RSV) announced in December 2022.

Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg Pharma, commented: "Our collaboration with CytoReason has put Poolbeg at the forefront of AI drug discovery. CytoReason's deep interrogation of the uniquely rich data derived from human challenge trials has deepened our knowledge of influenza, resulting in the identification of multiple novel influenza drug targets. There is a significant unmet need for new and better treatments for vulnerable patients with influenza and this is a major milestone in the delivery of new therapies that can improve patient outcomes and global health."

David Harel, Chief Executive Officer of CytoReason, said:

"Once again, we're pleased to see that leveraging CytoReason's computational disease models to extract insights from Poolbeg's unique human challenge data can optimise the target discovery process. More importantly, these impressive results would not be possible without the commitment, transparency, and reciprocity of both teams."

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Further detail on the power of human challenge trial data

Poolbeg Pharma has access to a unique repository of clinical samples and associated data from human challenge trials. Data from human challenge trials 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. This data is unique in the depth of longitudinal virology, health, biomarker and symptom data collected during the course of disease.

About Influenza

Influenza is a viral pathogen that infects approximately one-eighth of the world's population each year, an estimated 1 billion people are infected globally, attacking the respiratory system and leading to between 5 and 10 million hospitalisations and as many as 500,000 influenza related deaths. Survivors of influenza can suffer organ damage, leading to chronic and life-changing injuries.

About Poolbeg Pharma

Poolbeg Pharma specialises in the development of innovative medicines to address the unmet need in infectious and other prevalent 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. Through opportunistic identification of assets which complement Poolbeg's existing pipeline, the Company is progressing programmes in oncology and metabolic syndromes; adding disease areas with significant addressable markets.

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 and other acute inflammatory conditions (POLB 001) which produces a highly significant reduction in p38 MAP kinase driven cytokines in a clinical setting; 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 or follow us on Twitter and LinkedIn @PoolbegPharma.

About CytoReason

CytoReason is a tech company developing computational disease models. With CytoReason's innovative technology and top-tier science, pharma and biotech companies identify new opportunities, shorten trial phases, reduce development costs, and increase the likelihood of drug approval. Multiple stakeholders in the organization rely on CytoReason to make data-driven decisions. Scientists can identify targets and prioritize indications. Managers can compare one drug across several diseases, or multiple drugs across one disease. And C-level executives can manage entire drug portfolios. CytoReason was founded in 2016 and is headquartered in Tel Aviv. For more information, visit www.cytoreason.com or follow us on LinkedIn or Twitter.