Poolbeg Pharma Regulatory News (POLB)

Poolbeg Pharma plc

Influenza Artificial Intelligence model build completed

CytoReason analysis of human challenge trial data on track to deliver outputs in Q2 2023

29 November 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 March 2022, the construction of the computational artificial intelligence (AI) influenza disease model has been completed by CytoReason Limited ('CytoReason'), indicating that it is on track to deliver outputs in Q2 2023.

The model aims to unlock clinically meaningful insights into influenza infection and recovery through the analysis of Poolbeg's unique human challenge trial data. CytoReason has now built a tailored AI model using Poolbeg's data which will allow the team to identify novel influenza drug targets for Poolbeg.

CytoReason's technologies are externally validated through its commercial partnerships with five of the world's top ten global pharma companies accessing its world-leading AI models, including Pfizer, Roche, and Sanofi. CytoReason's application of Poolbeg's unique human challenge trial data to build and train its first AI model in infectious diseases further testifies to the value of this data.

CytoReason's world leading algorithms and experts will enable the Poolbeg team to identify the most promising drug targets to treat disease. The Company plans to source drugs with existing Phase I safety data that, in line with the Poolbeg business model, can immediately continue clinical development to rapidly generate early human proof of concept data for influenza, with the ultimate aim of monetising the asset through partnerships and licensing deals with pharma and biotech.

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

"CytoReason builds world-class AI disease models and we look forward with great anticipation to the outputs from their analysis of our unique repository of clinical samples and associated data from influenza human challenge trials. Indeed this is the first time that AI is being used to analyse influenza human challenge trial data which Poolbeg is proud to be part of."

"Completion of this first stage of development demonstrates yet another milestone reached in the Company's stated R&D strategy and brings us one step closer to realising the significant opportunities that arise from this partnership. There is a growing focus on AI discovered drug targets within the industry and we are assessing interest in collaboration opportunities for our AI-enabled novel targets which we expect in Q2 2023 from this programme."

David Harel, CEO of CytoReason, said:

"Now that our influenza disease model has been enriched by Poolbeg's unparalleled data, we are excited to evaluate the novel disease mechanisms on our platform. This will potentially identify drug targets that can be used to develop treatments for influenza, a significant global health threat, in a much shorter time-frame and more cost effectively than with traditional reductionist analysis and drug discovery techniques."

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Further detail on Poolbeg's Artificial Intelligence Programmes

Poolbeg Pharma has access to a unique private repository of clinical samples and associated data from human challenge trials via its relationship with hVIVO plc (formerly Open Orphan plc), a resource which is anticipated to expand over the coming years. 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. These datasets provide clinical insights into disease that guides Poolbeg Pharma's product acquisitions and clinical development.

CytoReason's machine learning algorithm works by combing through enormous repositories of clinical data to build models of human disease, which can then be used by biotech and pharmaceutical partners to identify novel targets, prioritise mono/combination therapies, find biomarkers, and understand which patients will benefit most from those new treatments. CytoReason will be analysing blood transcriptomics, proteomics, DNA sequences and viral loads and disease signs and symptoms from the human challenge trials. The aim is for CytoReason to prioritise new drug targets quickly and cost effectively, in a manner consistent with Poolbeg's business model.

The Company is currently progressing two AI Programmes, the first in RSV in partnership with OneThree Biotech, and the second in influenza in partnership with CytoReason. Poolbeg believe that this is the first time that AI analysis has been undertaken on RSV and influenza human challenge trial data and samples to identify new drug targets and treatments. The unique nature of human challenge trials to produce disease progression data with high precision is revolutionising the insights into human 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 infected globally, attacking the respiratory system 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. Health organisations have warned that the upcoming influenza season could be especially severe, as a consequence of low immunity to the virus due to the pandemic causing a break in exposure.

About Poolbeg Pharma

Poolbeg Pharma is a clinical stage infectious disease pharmaceutical company, with a unique 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 pharma and biotech 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 hVIVO plc (formerly named 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 commenced its LPS human challenge trial with initial results expected by year end 2022; 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 an oral vaccine delivery platform 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 2022. 

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

About CytoReason

CytoReason is a leading technology company developing computational disease models. The company collects proprietary data from pharmaceutical companies and uses it to simulate human diseases - tissue by tissue and cell by cell. With CytoReason's massive database and AI-led platform, pharma and biotech companies can identify new opportunities, shorten trial phases, reduce development costs, and increase the likelihood of drug approval. To date, five of the world's top ten pharma companies use CytoReason's technology. For more information, visit www.cytoreason.com or follow us on LinkedIn or Twitter.