Poolbeg Pharma (POLB ) has signed a clinical trial agreement with the Centre for Human Drug Research (CHDR) to initiate a human challenge study of POLB 001 in June 2022.
POLB 001, which selectively inhibits overwhelming inflammation in viral infections, was identified using unique disease progression data available from human challenge trials.
The first results of the study, which will be a bacterial lipopolysaccharide (‘LPS’) human challenge study, are expected before the end of 2022 at which point the company aims to rapidly monetise by partnering or out licensing the asset for further development.
As part of this study, in line with Poolbeg’s capital light approach, researchers will stimulate the immune systems of healthy volunteers with LPS in a safe and controlled environment.
LPS emulates a robust immune response acting as a simulant for the hyperinflammatory effects associated with severe influenza infections which CHDR will use to measure the efficacy of POLB 001 as its mode of action is to block this hyper-immune response.
This differs from existing treatments because it targets the host immune response rather than the virus itself and is therefore unaffected by viral variance, Poolbeg explained to investors.
Cases of influenza, which remain at their highest globally since the onset of the COVID-19 pandemic, affects 1 in 8 of the global population and causes 500,000 deaths each year.
Poolbeg, which has defined and formulated the oral administration of POLB 001, already has sufficient grade and quantities of the drug to utilise immediately in this human challenge study.
In the study the LPS will be administered both intradermally through a shallow injection and intravenously through an injection of a vein. By administering the LPS intradermally, Poolbeg can then gather data around the localised response of the body to POLB 001, it explained.
‘By then administering the LPS intravenously, data can be gathered around the full body systemic response to POLB 001. By using both methods within one study, the Company will efficiently and cost effectively collect both local and systemic efficacy data, increasing the value of the data package which will be attractive to potential partners,’ it further highlighted.
Overall, the human challenge study is expected to generate key human data on the efficacy of the POLB 001 asset in dampening the immune response in otherwise healthy volunteers.
Commenting on this morning’s news, Dr Jeremy Skillington, CEO of Poolbeg Pharma said:
“We are moving forward at a strong pace to enable the upcoming human challenge clinical trial of POLB 001 to commence as planned. This study will provide invaluable early human data on the efficacy of this asset in dampening the immune response after being stimulated, thereby limiting the damage it can otherwise cause in a setting such as severe influenza.”
He added: “We are looking forward to receiving the broad spectrum of data from this study, given that it will be completed both intradermally and intravenously, thus maximising the data package that can be shared with any potential pharma or biotech licensing partner.”
Poolbeg said it continues to progress two AI programmes to complete analysis of influenza and Respiratory Syncytial Virus data faster and more cost effectively than previously possible.
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