Poolbeg Pharma signs GMP manufacturing agreement for POLB 001
(POLB ) announced that it has signed a contract for GMP manufacturing agreement that will ensure the ample supply of its lead asset, POLB 001, a small molecule immunomodulator which aims to address a significant unmet need in severe influenza.
The clinical stage infectious disease pharmaceutical company said the ample supply of GMP grade POLB 001 from the manufacturing agreement will be used in an upcoming bacterial lipopolysaccharide (LPS) human challenge trial which is due to commence in June 2022.
It will also be used to investigate POLB 001 as a treatment for other disease indications since Poolbeg says POLB 001 has potential therapeutic applications beyond severe influenza, “due to its mode of action of reducing hyperinflammation which is linked with many diseases.”
This is when harmful inflammation occurs in different areas of the body, such as the heart and lungs, causing organ damage, and Poolbeg says POLB 001 can block this from happening.
Currently, Poolbeg Pharma holds the worldwide rights to the POLB 001 asset for all uses in humans and as such, is in a position to expand its IP around this asset to cover new disease areas which greatly increases the value of the program for partnering purposes, it explained.
Following the receipt of the results from the upcoming bacterial lipopolysaccharide (LPS) human challenge trial, the Company aims to rapidly monetise POLB 001 by partnering or out licensing the product to pharma / biotech for further development and commercialization.
The GMP manufacturing of the product began in late 2021 to ensure that sufficient grade and quantities of the product is available for use in the forthcoming human challenge trial which is due to commence in June 2022, with first results expected before the end of the year.
The Company acknowledged that it now has a validated manufacturing process for the development of the product for use in its clinical development for multiple disease areas.
Poolbeg Pharma signed the Clinical Trial Agreement with the Centre for Human Drug Research (CHDR) back in March 2022 for the upcoming LPS human challenge study.
As part of the study, which is being completed in line with Poolbeg’s capital light approach, researchers will stimulate healthy volunteers’ immune systems with LPS which triggers a robust immune response acting as a simulant for the hyperinflammatory effects associated with severe influenza infections, as well as other diseases, the company informed investors.
The study is expected to provide key human data on the efficacy of POLB 001 in dampening the immune response in otherwise healthy volunteers.
Commenting, Jeremy Skillington, PhD, CEO of Poolbeg Pharma said: “Preparations for the upcoming clinical trial of our lead asset, POLB 001, are progressing well and we are delighted to have executed a GMP manufacturing contract ensuring ample supply of POLB 001 for use in its clinical development for severe influenza and beyond.”
“With a mode of action which reduces the body’s hyperinflammatory response, POLB 001 has the potential to address several disease indications beyond severe influenza,” he commented.
He said this could provide Poolbeg with the opportunity to “greatly increase the value of the program for partnering and monetisation of POLB 001 to pharma or biotech companies.”
View from Vox
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, Poolbeg Pharma is targeting this growing infectious disease market.
Since its IPO a year ago, Poolbeg has made significant progress in developing new products including, inter alia, its development of the POLB 001 programme for severe influenza with the first human challenge clinical trial due to commence in June 2022, as well as the firm’s partnerships with two leading AI firms for its RSV Artificial Intelligence Discovery Programm.
The latter partnerships are aimed at using a proprietary data bank of disease progression data to identify new treatments, and the results of the programme are expected in 2H22.
Poolbeg Pharma was trading 0.93% during Thursday morning trading at 5.45p.
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