Poolbeg Pharma, a clinical stage infectious disease pharmaceutical company, has received ethics and competent authority approval to commence its lipopolysaccharide (LPS) human challenge clinical trial for POLB 001, a strain agnostic, small molecule immunomodulator which aims to address the unmet medical need for a treatment for severe influenza.
Clinical trial activities will formally commence on July 22, 2022.
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.
Initial results are expected in Q4 2022, at which point the company intends to rapidly monetize by out-licensing/partnering with pharma and biotech companies for further development of POLB 001.
The company said trial success would also pave the way for potential applications beyond severe influenza.
Jeremy Skillington, CEO of Poolbeg Pharma, said: “This is a major milestone for Poolbeg as we are ready to commence the LPS human challenge trial of POLB 001, our severe influenza treatment. Significant preparatory work has been completed in order to reach this stage with the completion of GMP (good manufacturing process) manufacturing, formulation, trial protocol design amongst other vital regulatory requirements.
“We look forward to receiving the valuable, broad-ranging data and insights that this trial is expected to generate by the end of 2022. We stated at our IPO in July 2021 that we intended to bring POLB 001 into the clinic for this LPS trial in the summer of 2022 and are happy to have achieved this stated objective and demonstrate our ability to effectively execute on our strategy.
“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.”
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 Matthijs Moerland and the trial will be conducted at the Centre for Human Drug Research in The Netherlands.
POLB 001 has previously been proven to be safe and well tolerated in a phase I clinical trial.
Mode of action
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, Poolbeg Pharma said, 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.
The company was also in the news recently when its artificial intelligence (AI) partner, OneThree Biotech, Inc., completed the build and optimization of a tailored AI model of Poolbeg Pharma’s respiratory syncytial virus (RSV) human challenge data.