Major milestone reached as POLB 001 human challenge clinical trial ready to commence
Regulatory approval gives green light for trial to proceed
Key Highlights:
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Clinical trial activities will formally commence on |
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The trial will assess the efficacy of POLB 001 in dampening the robust immune response to LPS which acts as a surrogate for the hyperinflammatory response associated with severe influenza and other diseases |
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Start of the trial demonstrates significant delivery on commitment at IPO |
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Initial results expected in Q4 2022 at which point the Company intends to rapidly monetise by out-licensing / partnering with pharma and biotech companies for further development of POLB 001 |
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Trial success would also pave the way for potential applications beyond severe influenza |
"The unmet need for new treatments for severe influenza presents a significant opportunity to improve outcomes for patients as well as to potentially rapidly monetise our lead asset. The unique mode of action of POLB 001 to reduce hyperinflammatory response in the body means that it is agnostic to the strain of virus and has the potential to expand to other disease indications and as such, could provide further opportunities to create significant value beyond severe influenza for the Company and our shareholders."
*Good Manufacturing Practice
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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
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
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 will commence its LPS human challenge trial imminently, with results expected by year end 2022. 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
Further detail on the LPS trial, POLB 001 and the Influenza opportunity and beyond
Rigorous randomised, double-blind, placebo-controlled, multiple dose, LPS human challenge trial in 36 healthy volunteers to assess efficacy of POLB 001 in treating the dangerous effects of severe influenza. As part of the trial, researchers will stimulate the immune systems of healthy volunteers with 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.
The Principal Investigator is Dr.
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. Given POLB 001's mode of action, it is strain agnostic meaning that it treats the body's reaction to infection rather than targeting the virus directly and, as such, POLB 001 is unaffected by the seasonal variants of influenza that arise each year which is a significant advantage over treatments available on the market. Therefore, POLB 001 has the potential to be a transformational treatment for patients and to become a leading severe influenza treatment. POLB 001 has patent protection until 2038 and is a shelf-stable oral drug which makes it ideal as a stockpiling candidate for both seasonal outbreaks and pandemic preparedness.
POLB 001 also has potential therapeutic applications beyond severe influenza, due to its mode of action of reducing hyperinflammation (cytokine storm). This is when harmful inflammation occurs in different areas of the body, such as the heart and lungs, causing organ damage which is linked with many diseases. POLB 001 has the potential to block this by interrupting the positive feedback loop of inflammatory mediators. Poolbeg is currently investigating new potential uses and in due course hopes to expand its IP around this asset to cover new disease areas thereby increasing the value of the asset.