Poolbeg Pharma Regulatory News (POLB)

Poolbeg Pharma plc

POLB 001 US Patent update

Continued expansion of IP portfolio enhancing protection of Poolbeg's growing pipeline

4 October 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, provides an update on the strengthening of its intellectual property (IP) position around POLB 001, a small molecule immunomodulator for the treatment of severe influenza.

The US Patent and Trademarks Office, after reviewing a patent application that is directed to the use of POLB 001 and its homologues for the treatment of hypercytokinemia (or "cytokine storm"), has indicated to the Company that the main claim is allowable. Poolbeg anticipates receiving a formal patent grant in due course and has filed a continuing application to seek protection for additional claims around this indication.

Poolbeg has a worldwide license for POLB 001 for all uses in humans and is developing a strong IP portfolio with patent protections in place covering the use of the class of p38 MAP kinase (mitogen-activated protein kinase) inhibitors for the treatment or prevention of severe influenza and hypercytokinaemia. The Company is exploring the opportunity to expand its IP around this asset to cover new disease areas which could enhance the value of the asset for partnering purposes.

US and European patents have already been granted with claims to the treatment of severe influenza, which is characterised by symptoms that persist or recur for more than two days without signs of resolution, with a p38 MAP kinase inhibitor inhibiting the release of pro-inflammatory mediators from endothelial cells and pro-inflammatory cytokines from immune cells. These granted patents offer protection until at least 2037.

Assessment of applications filed in other territories is ongoing.

Jeremy Skillington, PhD, CEO of Poolbeg Pharma said:

"We are continuing to expand our global patent protection for our growing pipeline of infectious disease products. We are delighted to receive confirmation from the US Patent and Trademarks office that the main claim is allowable, and we look forward to updating the market when we receive the formal patent grant in due course. Enhanced IP protection of our assets across key markets, such as the US, increases the overall value of these products to potential partners. This is particularly important as we move closer to the completion of our POLB 001 LPS human challenge trial, with initial results expected by year end 2022."

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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 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 POLB 001

POLB 001 is a small molecule immunomodulator for the treatment of 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.

POLB 001 entered the clinic in July 2022 and a rigorous randomised, double-blind, placebo-controlled, multiple dose, LPS human challenge trial in 36 healthy volunteers is ongoing to assess the efficacy of POLB 001 in treating the dangerous effects of severe influenza. As part of the trial, researchers stimulate the immune systems of healthy volunteers with bacterial lipopolysaccharide (LPS) across three cohorts. LPS triggers a robust immune response and acts as a surrogate for the hyperinflammatory effects associated with severe influenza infection, as well as other diseases. Each cohort will receive escalating doses of POLB 001 to evaluate its effectiveness in suppressing the body's harmful inflammatory response to both intradermal (a shallow injection) and intravenous (an injection in a vein) administered LPS. POLB 001 has previously been proven to be safe and well tolerated in a successful Phase I clinical trial.

The LPS challenge trial will efficiently, and cost effectively collect both local and systemic efficacy data creating a comprehensive data package which will be attractive to potential partners. First results of this LPS human challenge trial are expected before year end 2022, and the Company expects to be in a position to rapidly partner or out-license the product to pharma or biotech for further development and commercialisation thereafter, initial interactions with potential partners is progressing positively.

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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 severe influenza can suffer organ damage, leading to chronic and life-changing injuries.