The immunomodulator is being developed to address the unmet medical need arising from severe influenza and other acute inflammatory conditions.
After a positive indication in October last year, the USPTO granted a patent for the use of POLB 001 and related p38 MAP kinase (mitogen-activated protein kinase) inhibitors for the treatment of hypercytokinaemia (or cytokine storm), including hypercytokinaemia. This occurs due to viral infection such as an influenza virus, cancer, or an autoimmune response, through the modulation of the immune response - reducing the body’s hyperinflammatory response.
Poolbeg has a worldwide license for POLB 001 for all uses in humans and is developing a strong IP portfolio with US patent protection in place covering the use of a wide range of p38 MAP kinase inhibitors and a European patent for the class of p38 MAP kinase inhibitors for use in the treatment of severe influenza.
In January 2022, the company filed a patent application to seek class protection for the novel use of p38 inhibitors in CAR T cell treatment. This, Poolbeg says opens a significant new market opportunity for POLB 001 beyond severe influenza. The company continues to explore opportunities to expand its IP around this asset to cover new disease areas which could enhance the value of the asset.
It continues to work with its patent advisors to broaden and expand its patent families.
Jeremy Skillington, CEO of Poolbeg Pharma, said: “We are expanding our IP portfolio across the globe, allowing us to continue advancing and protecting our programmes for the treatment or prevention of severe influenza and hypercytokinaemia.
“Enhanced IP protection of our assets across key markets, such as the US, increases the overall value and attractiveness of these products to potential partners. This is particularly important in the light of the recent favourable results from our POLB 001 LPS human challenge trial announced 2 March 2023.”
Poolbeg continues to discover new indications for POLB 001 in other acute inflammatory conditions. It says POLB 001 selectively inhibits overwhelming inflammation that may be triggered by viral infections, such as severe influenza, while leaving the necessary immune functions intact to fight the infection.
The company says this contrasts with other immunomodulatory approaches, such as steroids, which affect both beneficial and damaging immune responses. Due to its mode of action, it is strain agnostic and unaffected by seasonal variants which is a significant advantage over treatments available on the market. In addition, as a shelf stable oral drug it is an ideal stock piling candidate for both seasonal and pandemic outbreaks. Therefore, the company says, POLB 001 has the potential to be a transformational treatment for patients and to become a leading severe influenza treatment.