Poolbeg Pharma PLC Update on POLB 001 Clinical Development (7494S)
18 November 2021 - 6:00PM
UK Regulatory
TIDMPOLB
RNS Number : 7494S
Poolbeg Pharma PLC
18 November 2021
Poolbeg Pharma plc
Update on POLB 001 Clinical Development
Rapidly progressing towards LPS challenge study
18 November 2021 - Poolbeg Pharma (AIM: POLB, 'Poolbeg' or the
'Company') a clinical stage infectious disease pharmaceutical
company with a capital light clinical model, is pleased to provide
an update on the clinical development progress of its lead asset,
POLB 001, a small molecule immunomodulator for the treatment of
severe influenza.
The Company intends to commence the Phase Ib human challenge
study of POLB 001 in June 2022 which will be a key step in the
molecule's development. To enable this study, the Company has
signed a Letter of Intent to retain the Centre for Human Drug
Research (CHDR) to run the challenge study and signed an agreement
with SEDA Pharmaceutical Development Services for drug formulation
services. A vendor has also been selected for GMP* manufacturing of
POLB 001.
In this study, clinical researchers from CHDR will stimulate a
healthy volunteer's immune system with bacterial lipopolysaccharide
(LPS) in a safe and controlled clinical environment. The study will
provide key human data on the efficacy of POLB 001 in dampening the
immune response in otherwise healthy volunteers. It will use LPS to
simulate the effects of treating severe influenza in the volunteers
without the virus itself being present. In cases of severe
influenza, the body produces an over-heightened immune response
that can cause more damage to the body than the virus itself. POLB
001's mode of action is to reduce this hyper-immune response. The
design of the study (the study protocol) is expected to be
finalised by the end of Q1 2022.
In advance of the Phase Ib study commencing, the Company has
completed the manufacturing of a non-GMP* batch of POLB 001 which
is on hand for any non-clinical (not administered to humans)
requirements, such as formulation. This is also an important step
in validating the manufacturing process. On this basis,
manufacturing can now be scaled up as required as the clinical
development phase progresses. The Company will now move towards
manufacturing GMP* grade POLB 001 material needed for the LPS
challenge study and has similarly selected a vendor for this
work.
Jeremy Skillington, PhD, CEO of Poolbeg Pharma said:
"We are delighted to be progressing our POLB 001 asset as
planned, with preparatory steps in motion in advance of the LPS
human challenge study clinical trial. We have selected experienced
partners in SEDA to formulate the product, and CHDR to run our LPS
human challenge study. The clinical study is expected to commence
in June 2022, as detailed at IPO. With our capital light and early
monetisation model, we are actively developing infectious disease
assets with modest investment where they can be monetised /
licenced to Big Pharma. We will continue to provide updates as we
progress the programme."
*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.
-Ends-
Enquiries
Poolbeg Pharma Plc
Jeremy Skillington, CEO
Ian O'Connell, CFO +353 (0) 1 644 0007
finnCap Ltd (Nominated Adviser & Joint
Broker)
Geoff Nash, James Thompson, Charlie
Beeson,
Richard Chambers, Sunila de Silva (ECM) +44 (0) 20 7220 0500
Arden Partners PLC (Joint Broker)
John Lewellyn-Lloyd, Louisa Waddell +44 (0) 207 614 5900
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 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 Big Pharma seeking mid-stage products to licence 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. It already has a Phase II ready
repositioned small molecule immunomodulator for severe influenza
and a portfolio of other exciting assets. The Company plans to
broaden this portfolio further going forward and is in active
discussions with AI data analysis platforms to help accelerate the
power of its human challenge model data and biobank.
For more information, please see www.poolbegpharma.com .
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