# Poolbeg Pharma POLB 001 patent portfolio strengthened

- Link: https://www.directorstalkinterviews.com/poolbeg-pharma-polb-001-patent-portfolio-strengthened/4121109102
- Published: 2023-03-08T07:19:56+00:00
- Author: Madison Wilson

**Poolbeg Pharma** ([LON:POLB](https://www.directorstalkinterviews.com/company/poolbeg-pharma-plc/polb.l),
OTCQB: POLBF),  a leading infectious disease focused biopharmaceutical company, 
has announced that further to its announcement on 4 October 2022, it has been granted
a patent by the US Patent and Trademark Office (USPTO) for methods of treating hypercytokinaemia
using POLB 001, a small molecule immunomodulator being developed to address the 
unmet medical need arising from severe influenza and other acute inflammatory conditions.

**Key highlights**

·      **Patent granted for use of certain p38 MAP kinase inhibitors for the treatment
of hypercytokinaemia**

·      **Allows for use in combination with an antiviral agent**

·      **Patent enhances the robust IP portfolio protecting Poolbeg’s growing pipeline**

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 that 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 Pharma 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 (mitogen-activated protein kinase) inhibitors
for the treatment of symptoms of severe influenza and hypercytokinaemia 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 opens up a significant
new market opportunity for POLB 001 beyond severe influenza. Poolbeg continues to
explore opportunities to expand its IP around this asset to cover new disease areas
which could enhance the value of the asset.

The Company continues to work with its patent advisors to broaden and expand its
patent families.

> **Jeremy Skillington, PhD, 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_.”_

**About POLB 001**

POLB 001 is a small molecule immunomodulator for the treatment of symptoms of severe
influenza, and hypercytokinaemia which may occur due to exposure to a pathogen or
be triggered by cancer or an autoimmune response. Poolbeg continues to discover 
new indications for POLB 001 in other acute inflammatory conditions. 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. 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, POLB 001 has the potential to be a transformational treatment for patients
and to become a leading severe influenza treatment.

Cytokines, originally intended to optimise immunity, when overexpressed can sweep
throughout the body re-programming white blood cells causing tissue damage, shutting
down circulation and other essential organs leading to death and in certain circumstances
cytokine storm or cytokine release syndrome (CRS). Such excessive cytokine responses
can be seen in diseases as diverse as severe influenza and in response to chimeric
antigen receptor T cell therapy (CAR T cell) treatment of cancers. Poolbeg continues
to evaluate POLB 001’s potential in additional indications to fully unlock the potential
value of the molecule.

p38 MAP kinase (p38 MAPK) is a master regulator of immunity, ubiquitously expressed
in all white blood cells where it is poised to unleash inflammation. Poolbeg’s clinical
approach, inhibiting p38 MAP kinase hypothesised that it’s a prime suspect in driving
the cytokine storm and its consequences in patients whose immune responses do not
resolve normally, without intervention. This has now been demonstrated as a concept
in a human clinical model of infectious disease and endotoxin mediated inflammation
administering LPS as the endotoxin to healthy volunteers. LPS is a bacterial product
that mimics infection and is used to capture the hallmarks of both local and systemic
inflammation typical of a cytokine storm in humans, but in a safe, controlled and
quantifiable manner – it’s one step removed from the infected critical care patient.
Treatment with POLB 001 resulted in a highly significant reduction in p38 MAP kinase
driven cytokines and exhibited a marked reduction in multiple markers of systemic
and local inflammation compared with placebo. 

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