TIDMPOLB
RNS Number : 6380B
Poolbeg Pharma PLC
04 October 2022
Poolbeg Pharma plc
POLB 001 US Patent update
Continued expansion of IP portfolio enhancing protection of
Poolbeg's growing pipeline
4 October 2022 - Poolbeg Pharma (AIM: POLB, OTCQB: POLBF,
'Poolbeg' or the 'Company'), a clinical stage infectious disease
pharmaceutical company with a unique capital light clinical model,
provides an update on the strengthening of its intellectual
property (IP) position around POLB 001, a small molecule
immunomodulator for the treatment of severe influenza.
The US Patent and Trademarks Office, after reviewing a patent
application that is directed to the use of POLB 001 and its
homologues for the treatment of hypercytokinemia (or "cytokine
storm"), has indicated to the Company that the main claim is
allowable. Poolbeg anticipates receiving a formal patent grant in
due course and has filed a continuing application to seek
protection for additional claims around this indication.
Poolbeg has a worldwide license for POLB 001 for all uses in
humans and is developing a strong IP portfolio with patent
protections in place covering the use of the class of p38 MAP
kinase (mitogen-activated protein kinase) inhibitors for the
treatment or prevention of severe influenza and hypercytokinaemia.
The Company is exploring the opportunity to expand its IP around
this asset to cover new disease areas which could enhance the value
of the asset for partnering purposes.
US and European patents have already been granted with claims to
the treatment of severe influenza, which is characterised by
symptoms that persist or recur for more than two days without signs
of resolution, with a p38 MAP kinase inhibitor inhibiting the
release of pro-inflammatory mediators from endothelial cells and
pro-inflammatory cytokines from immune cells. These granted patents
offer protection until at least 2037.
Assessment of applications filed in other territories is
ongoing.
Jeremy Skillington, PhD, CEO of Poolbeg Pharma said:
"We are continuing to expand our global patent protection for
our growing pipeline of infectious disease products. We are
delighted to receive confirmation from the US Patent and Trademarks
office that the main claim is allowable, and we look forward to
updating the market when we receive the formal patent grant in due
course. Enhanced IP protection of our assets across key markets,
such as the US, increases the overall value of these products to
potential partners. This is particularly important as we move
closer to the completion of our POLB 001 LPS human challenge trial,
with initial results expected by year end 2022."
- Ends -
Enquiries
Poolbeg Pharma Plc
Jeremy Skillington, CEO +44 (0) 20 7183
Ian O'Connell, CFO 1499
finnCap Ltd (Nominated Adviser & Joint
Broker)
Geoff Nash, James Thompson, Charlie
Beeson,
Sunila de Silva (ECM), Nigel Birks +44 (0) 20 7220 0500
Singer Capital Markets (Joint Broker)
Phil Davies, Sam Butcher +44 (0) 20 7496 3000
J&E Davy (Joint Broker)
Anthony Farrell, Niall Gilchrist +353 (0) 1 679 6363
Instinctif Partners +44 (0) 20 7457 2020
Melanie Toyne Sewell, Rozi Morris, poolbeg@instinctif.com
Tim Field
About Poolbeg Pharma
Poolbeg Pharma is a clinical stage infectious disease
pharmaceutical company, with a unique capital light clinical model
which aims to develop multiple products faster and more cost
effectively than the conventional biotech model. The Company,
headquartered in London, is led by a team with a track record of
creation and delivery of shareholder value and aspires to become a
"one-stop shop" for pharma and biotech seeking mid-stage products
to license or acquire.
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
$250bn by 2025.
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. Amongst its portfolio of
exciting assets, Poolbeg has a small molecule immunomodulator for
severe influenza (POLB 001) which has commenced its LPS human
challenge trial with initial results expected by year end 2022; a
first-in-class, intranasally administered RNA-based immunotherapy
for respiratory virus infections (POLB 002); and a vaccine
candidate for Melioidosis (POLB 003). The Company is also
developing an oral vaccine delivery platform and is progressing two
artificial intelligence (AI) programmes to accelerate the power of
its human challenge model data and biobank, with results from the
first programme expected by year end 2022.
For more information, please go to www.poolbegpharma.com or
follow us on Twitter and LinkedIn @PoolbegPharma.
About POLB 001
POLB 001 is a small molecule immunomodulator for the treatment
of severe influenza. POLB 001 electively inhibits overwhelming
inflammation in viral infections, such as 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.
POLB 001 entered the clinic in July 2022 and a rigorous
randomised, double-blind, placebo-controlled, multiple dose, LPS
human challenge trial in 36 healthy volunteers is ongoing to assess
the efficacy of POLB 001 in treating the dangerous effects of
severe influenza. As part of the trial, researchers stimulate the
immune systems of healthy volunteers with bacterial
lipopolysaccharide (LPS) across three cohorts. LPS triggers a
robust immune response and acts as a surrogate for the
hyperinflammatory effects associated with severe influenza
infection, as well as other diseases. Each cohort will receive
escalating doses of POLB 001 to evaluate its effectiveness in
suppressing the body's harmful inflammatory response to both
intradermal (a shallow injection) and intravenous (an injection in
a vein) administered LPS. POLB 001 has previously been proven to be
safe and well tolerated in a successful Phase I clinical trial.
The LPS challenge trial will efficiently, and cost effectively
collect both local and systemic efficacy data creating a
comprehensive data package which will be attractive to potential
partners. First results of this LPS human challenge trial are
expected before year end 2022, and the Company expects to be in a
position to rapidly partner or out-license the product to pharma or
biotech for further development and commercialisation thereafter,
initial interactions with potential partners is progressing
positively.
Learn more here
About Influenza
Influenza is a viral pathogen that infects approximately
one-eighth of the world's population each year, an estimated 1
billion people infected globally, attacking the respiratory system
leading to between 5 and 10 million hospitalisations and as many as
500,000 influenza related deaths. Survivors of severe influenza can
suffer organ damage, leading to chronic and life-changing
injuries.
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