Poolbeg Pharma plc (LON:POLB, OTCQB: POLBF), a clinical stage infectious disease pharmaceutical company with a unique capital light clinical model, has announced an update on its lead asset, POLB 001, a small molecule immunomodulator which aims to address a significant unmet need in severe influenza. The Company has signed a contract for GMP manufacturing, ensuring ample supply of GMP grade POLB 001 for use in its upcoming LPS human challenge clinical trial, due to commence in June 2022, and for use in investigating POLB 001 as a treatment for other disease indications.
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. POLB 001 can block this from happening. The Company holds the worldwide rights to POLB 001 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. Following 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 now has a validated manufacturing process for the development of the product for use in its clinical development for multiple disease areas.
The Company signed the Clinical Trial Agreement with the Centre for Human Drug Research (CHDR) in March 2022 for the upcoming LPS human challenge study. As part of the study, which is being completed in line with the Company’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 study will provide key human data on the efficacy of POLB 001 in dampening the immune response in otherwise healthy volunteers.
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, and with our exclusive license for all human uses 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.”
Note: 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.