Poolbeg Pharma Regulatory News (POLB)

Poolbeg Pharma Plc

Positive Initial Data Analysis in POLB 001 LPS Challenge Trial

Early data read out indicates a successful LPS human challenge trial

Key Highlights

· POLB 001 demonstrated a marked reduction in both systemic and localised inflammatory response compared to volunteers who received placebo

· A clear dose-response relationship was demonstrated

· Well tolerated across all doses and no serious adverse events or volunteer withdrawals were reported

· Full data read-out expected in Q2 2023 following a final quality check of the unblinded data

9 January 2023 - Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, 'Poolbeg' or the 'Company'), a leading infectious disease focused biopharmaceutical company, announces positive initial data analysis for POLB 001, a viral strain agnostic, small molecule immunomodulator being developed to address the significant unmet medical need for severe influenza.

As announced in December, full data read-out is expected in Q2 2023. However, upon initial review, the data indicates that administration of POLB 001 resulted in a marked reduction in both systemic and localised inflammatory response in subjects challenged with bacterial lipopolysaccharide ("LPS") compared to those who received placebo. A clear dose-response relationship was also apparent. This LPS challenge trial was designed to evaluate the effect of POLB 001 on inflammatory responses in 36 healthy volunteers between 18 and 55 years of age following both an intradermal and an intravenous LPS challenge. LPS acts as a surrogate for the hyperinflammatory response associated with severe influenza and other diseases. POLB 001 was well tolerated across all doses and no serious adverse events or volunteer withdrawals were reported.

Jeremy Skillington, CEO of Poolbeg Pharma, said: "Following the completion of the LPS human challenge trial in December, we are excited to see this positive initial data of POLB 001. The clear anti-inflammatory dose response, with no serious adverse events, further demonstrates the strong potential for POLB 001 to address the significant unmet medical need in severe influenza and beyond. We look forward to presenting the full data in Q2 2023.

We are delighted to have completed our first clinical trial on schedule, delivering on our business model of rapidly generating early human clinical data. We believe that the positive initial data is a significant value inflection point and will support discussions with partners."

About POLB 001

POLB 001 is a small molecule immunomodulator for the treatment of hypercytokinemia related diseases such as severe influenza. POLB 001 electively inhibits overwhelming inflammation in viral infections, such as influenza, while leaving the necessary immune functions intact to fight the infection. This contrasts with other immunomodulatory approaches, such as steroids, which affect both beneficial and damaging immune responses. Due to its mode of action it is strain agnostic and unaffected by seasonal variants which is a significant advantage over treatments available on the market. In addition, as a shelf stable oral drug it is an ideal stock piling candidate for both seasonal and pandemic outbreaks. Therefore, POLB 001 has the potential to be a transformational treatment for patients and to become a leading severe influenza treatment.

Virtual Company presentation

Jeremy Skillington, PhD, Chief Executive Officer, and Professor Brendan Buckley, Scientific Advisory Board member, will provide a live presentation via the Investor Meet Company platform on Monday 16 January 2023 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.

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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) in which initial data analysis indicates a marked reduction in both systemic and localised inflammatory response in an LPS human challenge trial (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 add promising new assets to its pipeline.

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