Update on POLB 001 Clinical Development
Rapidly progressing towards LPS challenge study
The Company intends to commence the Phase Ib human challenge study of POLB 001 in
In this study, clinical researchers from CHDR will stimulate a healthy volunteer's immune system with bacterial lipopolysaccharide (LPS) in a safe and controlled clinical environment. The study will provide key human data on the efficacy of POLB 001 in dampening the immune response in otherwise healthy volunteers. It will use LPS to simulate the effects of treating severe influenza in the volunteers without the virus itself being present. In cases of severe influenza, the body produces an over-heightened immune response that can cause more damage to the body than the virus itself. POLB 001's mode of action is to reduce this hyper-immune response. The design of the study (the study protocol) is expected to be finalised by the end of Q1 2022.
In advance of the Phase Ib study commencing, the Company has completed the manufacturing of a non-GMP* batch of POLB 001 which is on hand for any non-clinical (not administered to humans) requirements, such as formulation. This is also an important step in validating the manufacturing process. On this basis, manufacturing can now be scaled up as required as the clinical development phase progresses. The Company will now move towards manufacturing GMP* grade POLB 001 material needed for the LPS challenge study and has similarly selected a vendor for this work.
"We are delighted to be progressing our POLB 001 asset as planned, with preparatory steps in motion in advance of the LPS human challenge study clinical trial. We have selected experienced partners in SEDA to formulate the product, and CHDR to run our LPS human challenge study. The clinical study is expected to commence in
*Good Manufacturing Practice (GMP) is the regulatory code of standards that a medicine's manufacturer must meet in its production processes to enable administration to humans.
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Enquiries
Poolbeg Pharma Plc |
+353 (0) 1 644 0007 |
finnCap Ltd (Nominated Adviser & Joint Broker) |
+44 (0) 20 7220 0500 |
Arden Partners PLC (Joint Broker) |
+44 (0) 207 614 5900 |
|
+353 (0) 1 679 6363 |
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+44 (0) 20 7457 2020 |
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. It already has a Phase II ready repositioned small molecule immunomodulator for severe influenza and a portfolio of other exciting assets. The Company plans to broaden this portfolio further going forward and is in active discussions with AI data analysis platforms to help accelerate the power of its human challenge model data and biobank.
For more information, please see www.poolbegpharma.com.