Poolbeg Pharma Regulatory News (POLB)

Poolbeg Pharma Plc

OneThree Biotech completes build and optimisation of AI model for RSV data - results to come in H2

First time AI used to model RSV with complete longitudinal disease data

27 June 2022 - Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, 'Poolbeg' or the 'Company'), a clinical stage infectious disease pharmaceutical company with a unique capital light clinical model, announces that, further to its announcement in February 2022, Artificial Intelligence ('AI') partner OneThree Biotech, Inc., has completed the build and optimisation of a tailored AI model of Poolbeg's Respiratory Syncytial Virus ('RSV') human challenge data and can now commence its analysis, with results expected in Q4 2022.

Key Highlights:

The tailored AI model is the platform from which OneThree Biotech and Poolbeg will mine truly unique insights from human challenge trial* derived disease progression data, with the aim of identifying novel drug targets and therapies to treat RSV, a disease which is a significant public health threat.

OneThree's clinically validated model has been optimised to harness the unique longitudinal clinical, molecular (e.g. gene and protein expression) and virological data collected during human challenge trials, and includes next generation sequencing data captured daily at all timepoints before, during and after a healthy volunteer has been infected with RSV. The controlled environment of the human challenge trial creates a uniquely clean and complete dataset which is ideally suited for AI disease modelling such as this. The research team have integrated OneThree Biotech's world class AI, with Poolbeg's dataset and publicly available datasets to optimise the power of the model and validate its results. The team will use the model to discover and identify the disease signatures that define RSV infection and then identify drugs that can effectively reverse those signatures with therapeutically meaningful benefits with a view to then adding such identified drugs to Poolbeg's pipeline.

The research program will prioritise identifying drug candidates with existing Phase I safety and tolerability data generated during prior development for other disease indications. This approach significantly reduces spend and risk, with the resultant clinical development program rapidly progressing to a capital light clinical proof of concept trial. The approach is expected to generate multiple clinical stage candidates quickly and cost-effectively, in a manner consistent with Poolbeg's model.

Poolbeg also has an AI partnership underway with CytoReason which is focused on drug target identification for influenza infections. This is currently in the modelling stage and further updates will be provided in due course.

Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said:

"OneThree Biotech's AI model optimisation has been completed on time and is on-track to deliver results later this year. This is the first time that AI has been used to model RSV with the complete longitudinal disease data which can only be produced from human challenge trials. We are excited to see the insights into RSV that can be generated from this analysis which will help us to identify the best potential drug candidates to develop as part of our rapid, capital-light portfolio. RSV is a disease with a significant unmet medical need which causes an estimated 100,000 deaths per year in children under the age of five, we hope that the results from this programme can help us to identify an effective treatment to address this significant public health threat."

About RSV

RSV is a contagious virus that affects people's respiratory tract with children and at-risk older adults being particularly vulnerable; in severe cases, it can cause pneumonia and other life-threatening breathing difficulties. RSV is a significant public health threat affecting an estimated 50 million people annually, leading to 4 million global hospitalisations and an estimated 100,000 deaths in children under the age of 5 years. An estimated 45% of these cases and deaths occur in new-born infants under the age of 6 months. Studies have suggested that treatment for RSV in under 5s costs governments globally €4.8bn every year.

*Footnote: During a human challenge study, a number of healthy volunteers are exposed to an infectious agent in a safe and controlled quarantine setting to assess the efficacy of vaccines or treatments. Human challenge trial data is unique in the depth of longitudinal virology, health, biomarker and symptom data collected during the course of disease from pre-infection, onset, progression and resolution of an infection.

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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, please go to www.poolbegpharma.com or follow us on Twitter and LinkedIn @PoolbegPharma.