Poolbeg Pharma (POLB ) said it will commence a Phase Ib human challenge study of its lead asset POLB 001 next year in June 2022 which will be “a key step” in the molecule's development.
The infectious disease pharmaceutical firm, a spin-out of Open Orphan, said it has signed a letter of Intent to retain the Centre for Human Drug Research (CHDR) to run the study.
It has also 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 is expected to provide key human data on the efficacy of the POLB 001 asset 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 company explained to investors this morning.
The design of the study (the study protocol) is expected to be finalised by the end of 1Q22.
In advance of the Phase Ib study commencing next year, Poolbeg has completed the manufacturing of a non-GMP (Good Manufacturing Practice) batch of POLB 001 which is ‘on hand for any non-clinical (not administered to humans) requirements’, such as formulation.
The company said 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, and Poolbeg will move towards manufacturing GMP* grade POLB 001 material needed for the LPS challenge study and has similarly selected a vendor for this work.
Commenting, 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.
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."
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Last month, Poolbeg Pharma submitted further patent applications for PredictViral™, its disease severity platform which the company has described as a ‘transformative product’.
The infectious disease pharmaceutical firm, a spin-out of London-listed Open Orphan, said it will continue to expand its PredictViral™ IP portfolio beyond this morning’s latest application.
The latest patent aims to predict whether an individual exposed to a respiratory virus (such as Influenza, RSV) will have a higher severity of disease and / or be more likely to be contagious.
Addressing investors, Poolbeg Pharma said it believes that the PredictViral™ platform offers diagnostic companies ‘a transformative product that will enhance clinical decision-making while differentiating their platforms at a time of intense competition in this market.’
The predictive biomarker patent applications were filed on behalf of Poolbeg by Open Orphan’s subsidiary, hVIVO. As agreed as part of the demerger process, ownership will ultimately reside with Poolbeg Pharma which will continue to commercialise the platform.
Also last month, Poolbeg Pharma partnered with leading global biopharma services firm, Eurofins Genomics (‘Eurofins’), to complete RNA sequencing for Poolbeg of Respiratory Syncytial Virus (RSV) disease progression samples from human viral challenge studies.
The sequencing work marks a “key step” which will enable it to start AI analysis of its RSV data. This means Poolbeg will have full immunological datasets for RSV and influenza, which are ready to use with AI platforms to identify drug targets and products for these indications.
The project with Eurofins is expected to be completed by the end of 2021 and will involve next generation RNA sequencing of RSV transcriptomics, or disease progression data, which enables the tracking of the biology of immune responses in molecular detail during infection.
RSV is a contagious virus that affects the respiratory tract of children and at-risk older adults; in severe cases, it can cause pneumonia and other life-threatening breathing difficulties.
RSV is considered a significant public health threat and is one of the leading causes of hospitalisation to at-risk older adults. There is currently no vaccine on the market for RSV.
Looking ahead, Poolbeg said it will continue to expand its IP portfolio ‘as required.’
The global market for diagnostic tools for infectious disease is rapidly growing and is expected to be worth over $19 billion per annum by 2025. Poolbeg said discussions are ongoing with multiple parties to continue this technology’s development and license it for commercial use.
Chief Executive Officer of Poolbeg Pharma, Dr Jeremy Skillington, commented: “Protecting the IP for such an innovative disease severity platform as PredictViral™ is important and key to our strategy of commercialising this cutting-edge technology. PredictViral™ will provide valuable information for assessing the best course of treatment for viral disease.
He added that, “It has the potential to help early interventions when needed and to reduce the spread of disease, even amongst those who are unaware they are infected - the importance of which has become very clear during the COVID-19 global pandemic.”
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