Poolbeg Pharma granted additional US patents for POLB 001 and POLB 002.
(POLB ) announced that it has been granted patents by the US Patent and Trademark Office (USPTO) for the company’s two lead assets POLB 001 and POLB 002.
The clinical stage infectious disease pharmaceutical firm believes this additional US patent protection is an important step in the commercialisation of these infectious disease products.
Poolbeg’s POLB 001 asset is a small molecule immunomodulator that has been developed for the treatment of severe influenza in patients while its other POLB 002 asset is as an intranasally administered RNA-based immunotherapy targeting respiratory virus infections.
The Company’s aim is to broaden and expand the POLB 001 and POLB 002 patent families. Specifically, its focus is to enhance the IP protection of both of these lead assets across key markets such as the US increases the overall value of these products to potential partners.
For its POLB 001 asset, of which Poolbeg holds the worldwide rights to, the company intends to cover new disease areas which could maximise the value of 001 for partnering purposes.
The USPTO has now granted a patent for the majority of its claims around the use of certain p38 MAP kinase (mitogen-activated protein kinase) inhibitors for the treatment or prevention of severe influenza and the hypercytokinaemia (or “cytokine storm”) it causes via modulation of the immune response - reducing the body’s hyperinflammatory response to the virus.
To further strengthen its position, Poolbeg will pursue a continuation patent application to augment the protection offered by this patent family, it told its shareholders this morning.
In regard to POLB 002, the USPTO granted a patent for the identification of defective interfering (DI) RNA-based influenza viruses for use against infection by influenza, that provides a drug candidate with both antiviral prophylactic and therapeutic applications.
By having a dual mechanism of action, POLB 002 directly interferes with influenza virus replication blocking disease progression and also triggers nasal cells into an antiviral state. In this way, Poolbeg says POLB 002 could provide pan-viral protection from respiratory virus infections including influenza, respiratory syncytial virus (RSV), SARS-CoV-2 and others.
The Company further highlighted to investors that it continues to work alongside its patent advisors to broaden and expand the POLB 001 and POLB 002 patent families, respectively.
Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said: “The additional US patent protection of POLB 001 and POLB 002 is an important step in the commercialisation of these novel infectious disease products. Enhancing the IP protection of these assets across key markets such as the US increases the overall value of these products to potential partners, particularly as we move closer to the commencement of our POLB 001 LPS human challenge trial next month with data expected by year end and monetisation to commence thereafter.”
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In recent weeks, Poolbeg announced that it had signed a contract for GMP manufacturing agreement that will ensure the ample supply of POLB 001, which will be used in an upcoming bacterial lipopolysaccharide (LPS) human challenge trial due to commence in June 2022.
It will also be used to investigate POLB 001 as a treatment for other disease indications since Poolbeg says POLB 001 has potential therapeutic applications beyond severe influenza, “due to its mode of action of reducing hyperinflammation which is linked with many diseases.”
This is when harmful inflammation occurs in different areas of the body, such as the heart and lungs, causing organ damage, and Poolbeg says POLB 001 can block this from happening.
Following the receipt of the results from the upcoming bacterial lipopolysaccharide (LPS) human challenge trial, the
Company aims to rapidly monetise POLB 001 by partnering or out licensing the product to pharma / biotech for further development and commercialization.
The GMP manufacturing of the product began in late 2021 to ensure that sufficient grade and quantities of the product is available for use in the forthcoming human challenge trial which is due to commence in June 2022, with first results expected before the end of the year.
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, Poolbeg Pharma is targeting this growing infectious disease market.
Since its IPO a year ago, Poolbeg has made significant progress in developing new products including, inter alia, its development of the POLB 001 programme for severe influenza with the first human challenge clinical trial due to commence in June 2022, as well as the firm’s partnerships with two leading AI firms for its RSV Artificial IntelligenceDiscovery Programm.
The latter partnerships are aimed at using a proprietary data bank of disease progression data to identify new treatments, and the results of the programme are expected in 2H22.
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