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#POLB Poolbeg Pharma PLC – POLB 001 LPS Trial Data to be Presented at IUIS
16 November 2023 – Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, ‘Poolbeg’ or the ‘Company’), a biopharmaceutical company focussed on the development and commercialisation of innovative medicines targeting diseases with a high unmet medical need, announces that an abstract highlighting the potential of POLB 001 as a groundbreaking therapy has been accepted for presentation at the 18th International Congress of Immunology (‘IUIS’), to be held 27 November – 2 December 2023 in Cape Town, South Africa.
IUIS is the world’s leading conference in the field of immunology and attracts immunologists from universities, healthcare providers, independent research organisations and industry leaders. It serves as a premier platform for the exchange of the latest cutting-edge discoveries and advancements in immunological research.
The poster presentation will discuss POLB 001’s positive LPS human challenge trial results. POLB 001 is a potential treatment of severe influenza and Cytokine Release Syndrome (CRS) associated with cancer immunotherapies. CRS is a severe inflammatory response, which may be encountered as a side effect of some therapies, manifesting a range of symptoms that can rapidly progress to a severe life-threatening reaction. An effective therapy for CRS could unlock the benefits of cancer immunotherapies, benefiting patients and healthcare systems alike.
Title: Inhibition of local and systemic inflammatory responses by POLB 001, a novel p38 MAPK inhibitor, following in vivo LPS administration in healthy volunteers
Session Date: 1 December 2023
Presentation Time: 12pm – 1pm SAST
Location: Hall 2
Presenter: Digna de Bruin, The Centre for Human Drug Research
If you would like to meet with Poolbeg Pharma, get in touch at partnering@poolbegpharma.com
Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg Pharma, said: “The acceptance of this abstract at the upcoming IUIS conference underscores the potential of POLB 001 as a groundbreaking therapy. Severe influenza and Cytokine Release Syndrome associated with cancer immunotherapies are significant problems and an effective drug that can address these issues would have a significant impact on global health.”
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Enquiries
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Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O’Connell, CFO
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+44 (0) 207 183 1499 |
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Cavendish Capital Markets Ltd (Nominated Adviser & Joint Broker) Geoff Nash, Charlie Beeson, Nigel Birks, Harriet Ward (ECM)
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+44 (0) 207 220 0500 |
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Singer Capital Markets (Joint Broker) Phil Davies, Sam Butcher
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+44 (0) 207 496 3000 |
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J&E Davy (Joint Broker) Anthony Farrell, Niall Gilchrist
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+353 (0) 1 679 6363 |
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Optimum Strategic Communications Nick Bastin, Hana Malik, Vici Rabbetts
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+44 (0) 208 078 4357 |
About Poolbeg Pharma
Poolbeg Pharma plc is focussed on the development and commercialisation of innovative medicines targeting diseases with a high unmet medical need. Its model focusses upon developing its exciting clinical assets and commercialising approved and marketed drugs to fund the development of its robust pipeline of innovative products, thereby driving significant value creation.
Poolbeg is led by an experienced leadership team with a history of delivering significant shareholder value. The team and Board have been augmented with strong commercialisation expertise following the appointment of three former members of the Amryt Pharma plc leadership team, with the intention of repeating Amryt’s success and generating near term revenues.
Poolbeg’s clinical programmes target large addressable markets across cancer immunotherapies, infectious disease, and oral GLP-1 agonists for obesity and other metabolic conditions. It uses a cost-effective development philosophy to generate high quality human data to support partnering and further development. Its AI-led infectious disease programmes analyse unique data from human challenge trials to identify clinically relevant drug targets and treatments, leading to faster development and greater commercial appeal.
For more information, please go to www.poolbegpharma.com or follow us on Twitter and LinkedIn @PoolbegPharma.
#TEK Capital investee company #BELL Belluscura PLC – Orders for over 6,500 DISCOV-R™ received
LONDON, U.K. AND PLANO, TX, U.S. (16 August 2023). Belluscura plc (AIM: BELL), a leading medical device developer focused on lightweight and portable oxygen enrichment technology, announces that it has received purchase orders for over 6,500 of its next-generation DISCOV-R portable oxygen concentrator. This represents approximately $15 million of potential revenue to the Company, with initial production of the DISCOV-R expected to begin by the end of this quarter.
Following the pre-market launch of DISCOV-R and a patient usability study in June 2023, the Company plans a controlled roll out of the DISCOV-R this autumn and into 2024 to meet growing demand for the device amid substantial interest from medical device distributors, retailers, patients and durable medical equipment (DME) providers, among others.
The DISCOV-R is expected to be the world’s first ambulatory two litre continuous flow, eight level pulse dose portable oxygen concentrator when it is released. With the ability to produce two litres of continuous flow and maximum single pulse dose volumes exceeding 110ml, the Company believes that the DISCOV-R will be covered by both CMS E1390 (stationary) and E1392 (portable) reimbursement codes, making the DISCOV-R a better financial option for the thousands of homecare oxygen providers. It will also produce nearly three times as much oxygen by weight than its dual flow competitors.
The recent purchase orders follow the signing of several distribution agreements with medical device distributors and other home healthcare providers, including a distribution agreement with a division of McKesson, one of the largest distributors of pharmaceuticals and medical devices in North America, earlier this month and a marketing agreement with GoodRx®, a leading digital healthcare platform, in February 2023. The Company has received multiple additional requests from leading oxygen homecare providers in the US to distribute the DISCOV-R.
The Company will update the market later this year as it plans its controlled roll out of the DISCOV-R this autumn and into 2024.
Substantial progress on X-PLOR® and proprietary NOMAD biometric app
At the same time, the Company continues to progress its CE and UKCA registration mark application for its X-PLOR® portable oxygen concentrator. Since resources in the US were redirected to completing the development and launch of the DISCOV-R, production of X-PLOR by our Chinese partner, Innomax Medical Technology Ltd (Innomax), has now progressed, with 1,500 units recently being manufactured and shipped to the US for distribution.
The Company recently established a subsidiary and hired its first employees in Shenzhen, China as it prepares for the anticipated registration of the X-PLOR for sale and distribution in China and Hong Kong later this year. The Company and Innomax believe there is a significant market opportunity in China with approximately 100 million people suffering from COPD.
Additionally, the Company continues to drive innovation in telemedicine and artificial intelligence with its proprietary NOMAD biometric app. The NOMAD app will allow users of the DISCOV-R to track performance data on their concentrator and connected devices such as an Apple® or Samsung® Watch, FitBit® device or Nonin® and Masimo® pulse oximeters. The collective information can then be provided to a patient’s healthcare provider in person or remotely.
The Company is already working on the next-generation NOMAD app that will alert patients when their blood oxygen saturation level has varied beyond parameters set by their doctor, which is expected to help patients better monitor their conditions, but also improve the efficiency of the device by delivering supplemental oxygen as needed.
Bob Fary. Sr Vice President of Global Sales, Belluscura plc, commented:
“We are very excited about the overwhelming interest in the DISCOV-R by online retail sellers and other medical equipment providers. Following the pre-market launch of the product and the patient usability study in June, initial feedback suggests we will receive the same or greater level of interest from leading home healthcare providers once it is launched commercially.”
Bob Rauker, Chief Executive Officer, Belluscura plc, commented:
“We believe the DISCOV-R, combined with our proprietary NOMAD app, will be transformational to the portable oxygen industry and patient outcomes. This is reflected by early demand for the product prior to its full commercial launch, which is expected to take place later this year. The significant number of orders received demonstrates the substantial appetite for this product and we anticipate adding several more of these providers to our distribution network as we balance the high demand with production expectations over the next twelve months.
“This marks another exciting development for the Company, delivering on our strategy to design and manufacture highly differentiated, high quality and high margin products. Amid growing sales and continued progress with our X-PLOR device and NOMAD app, we continue to seek further opportunities to improve the quality of life for our end users”.
For further information please contact:
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Belluscura plc |
Tel: +44 (0)20 3128 8100 |
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Adam Reynolds, Chairman |
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SPARK Advisory Partners Limited Nominated Adviser |
Tel: +44 (0)20 3368 3550 |
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Neil Baldwin / Jade Bayat |
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Dowgate Capital Limited Broker |
Tel: +44 (0)20 3903 7715 |
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James Serjeant / Russell Cook |
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MHP Financial PR & Investor Relations |
Tel: +44 (0)20 3128 8100 email: Belluscura@mhpgroup.com |
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Katie Hunt/Matthew Taylor |
#POLB Poolbeg Pharma PLC – Annual Report & AGM Notice
Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, ‘Poolbeg’ or the ‘Company’), a leading biopharmaceutical company focusing on infectious and prevalent diseases with a high unmet medical need, confirms that the Company’s Annual Report and Accounts for the period ended 31 December 2022 and the notice of Annual General Meeting (“AGM”) 2022 have been posted to shareholders.
The 2022 Annual Report and Accounts, the Notice of AGM and accompanying form of proxy are available to download from the Company’s website: https://www.poolbegpharma.com/investors/documents/
The Annual General Meeting will be held at the offices of DAC Beachcroft LLP, 25 Walbrook, London EC4N 8AF, United Kingdom on 11 May 2023 at 12pm.
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Enquiries
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Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O’Connell, CFO
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+44 (0) 207 183 1499 |
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finnCap Ltd (Nominated Adviser & Joint Broker) Geoff Nash, Charlie Beeson, Nigel Birks, Harriet Ward (ECM)
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+44 (0) 207 220 0500 |
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Singer Capital Markets (Joint Broker) Phil Davies, Sam Butcher
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+44 (0) 207 496 3000 |
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J&E Davy (Joint Broker) Anthony Farrell, Niall Gilchrist
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+353 (0) 1 679 6363 |
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Optimum Strategic Communications Mary Clark, Nick Bastin, Vici Rabbetts
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+44 (0) 208 078 4357 |
About Poolbeg Pharma
Poolbeg Pharma specialises in the development of innovative medicines to address the unmet need in infectious and other prevalent diseases. Poolbeg has a disciplined portfolio approach to mitigate risk, accelerate drug development, and enhance investor returns. The Company simultaneously advances multiple programmes in cost-effective clinical trials, rapidly generating early human safety and efficacy data to enable early partnering / out-licensing, with the funds generated reinvested in the pipeline. Poolbeg also uses AI to interrogate human challenge trial data sets to quickly identify new targets and drugs, and in-license near or in the clinic medicines, leading to faster development and greater commercial appeal.
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. Through opportunistic identification of assets which complement Poolbeg’s existing pipeline, the Company is progressing programmes in oncology and metabolic syndromes; adding disease areas with significant addressable markets.
With its initial assets from hVIVO plc (formerly 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 and other acute inflammatory conditions (POLB 001) which produces a highly significant reduction in p38 MAP kinase driven cytokines in a clinical setting; 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 two Oral Delivery Programmes and is progressing two Artificial Intelligence (AI) Programmes to add promising new assets to its pipeline.
For more information, please go to www.poolbegpharma.com or follow us on Twitter and LinkedIn @PoolbegPharma.
#HVO hVIVO plc- Share Price
hVIVO plc (AIM: HVO) (formerly Open Orphan plc), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, saw the share price rise which was then picked up in the Daily Mail Stock Watch this morning
For further information please contact:
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hVIVO plc |
+44 (0) 20 7756 1300 |
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Yamin ‘Mo’ Khan, Chief Executive Officer Stephen Pinkerton, Chief Financial Officer |
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Liberum Capital (Nominated Adviser and Joint Broker) |
+44 (0) 20 3100 2000 |
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Ben Cryer, Edward Mansfield, Phil Walker, Will King |
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finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
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Geoff Nash, Charlie Beeson, Nigel Birks, Harriet Ward (ECM) |
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Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
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Anthony Farrell, Niall Gilchrist |
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Walbrook PR (Financial PR & IR) Stephanie Cuthbert / Phillip Marriage / |
+44 (0) 20 7933 8780 or hvivo@walbrookpr.com +44 (0) 7796 794 663 / +44 (0) 7867 984 082 / |
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UK Investor Magazine Podcast -CEO Alan Green discusses AstraZeneca, Georgia Capital and Vela Technologies
Alan Green joins the Podcast as we delve into key markets theme and a number of UK equities.
We discuss:
- AstraZeneca (LON:AZN)
- Georgia Capital (LON:CGEO)
- Vela Technologies (LON:VELA)
We start by looking at potential catalysts for markets as we move into the winter.
AstraZeneca has reported a solid set of third quarter results as the company sees the benefits of higher cancer drug sales.
Georgia Capital has been trading at deep discount to NAV and Alan outlines why he sees strength in the business going forward.
Vela Technologies shares jumped this week as they announced the IPO of a portfolio company on the NASDAQ.
Click on the image to listen or click here
#ORPH Open Orphan plc – Positive in vitro results for FLU-v published
Open Orphan plc (AIM: ORPH), (to be renamed hVIVO plc (AIM: HVO) effective 26 October 2022), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that positive data from a peer-reviewed study evaluating the in vitro efficacy of FLU-v, Imutex Limited’s (“Imutex”) broad spectrum influenza
vaccine, has been published in the scientific journal Vaccines.1
Previous clinical studies have demonstrated that FLU-v induced increased antibody and cellular responses in vivo. This placebo-controlled study evaluated the ability of FLU-v to induce cellular effector functions and cross-reactivity (both measures of the immune response, with cross-reactivity being particularly important for protection against multiple viral strains) of immune cells extracted from participants, following exposure to five different influenza strains.
The study found that measurements of IFN-γ and granzyme B production in stimulated immune cells from participants that had been previously vaccinated with either FLU-v or placebo, were significantly higher in the FLU-v group both when stimulated with vaccine antigen and also with antigens from a panel of seasonal and pandemic inactivated influenza A and B strains. These results further support the continued development of FLU-v as a broad-spectrum influenza vaccine.
FLU-v is owned by Imutex, a joint venture between hVIVO and PepTcell Limited (the legal name of SEEK Group), to develop vaccines against influenza and mosquito borne diseases such as Zika virus, malaria and other flaviviruses.
Seasonal influenza causes significant morbidity and mortality each year and a pandemic influenza continues to pose a worldwide threat. Influenza is a serious global health threat with an estimated 1 billion cases per year, 3-5 million severe cases and 290,000 – 650,000 deaths per year.
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “It is encouraging to see further positive data for FLU-v, supporting its continued development as a broad-spectrum influenza vaccine. There is a large unmet need for a broad-spectrum vaccine to help battle emerging seasonal and pandemic influenza A and B viruses. Although FLU-v had already produced successful Phase II clinical data, this in vitro study is particularly important as it showed the ability of the candidate to induce an immune response against a diverse variety of influenza A and B strains.”
1. Oftung, F.; Næss, L.M.; Laake, I.; Stoloff, G.; Pleguezuelos, O. FLU-v, a Broad-Spectrum Influenza Vaccine, Induces Cross-Reactive Cellular Immune Responses in Humans Measured by Dual IFN-γ and Granzyme B ELISpot Assay. Vaccines 2022, 10, 1528. https://doi.org/10.3390/vaccines10091528
For further information please contact:
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Open Orphan plc |
+44 (0) 20 7756 1300 |
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Yamin Khan, Chief Executive Officer |
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Walbrook PR (Financial PR & IR) Stephanie Cuthbert / Phillip Marriage / |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com +44 (0) 7796 794 663 / +44 (0) 7867 984 082 / |
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#POLB Poolbeg Pharma PLC – HC Wainwright Global Investment Conference
12 September 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, announces that the Company’s Chairman, Cathal Friel, will be attending the HC Wainwright Global Investment Conference, which is taking place from 12-14 September at the Lotte New York Palace Hotel in New York City, NY, USA.
Enquiries
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Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O’Connell, CFO
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+44 (0) 20 7183 1499 |
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finnCap Ltd (Nominated Adviser & Joint Broker) Geoff Nash, James Thompson, Charlie Beeson, Richard Chambers, Sunila de Silva (ECM), Nigel Birks
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+44 (0) 20 7220 0500 |
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Singer Capital Markets (Joint Broker) Phil Davies, Sam Butcher
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+44 (0) 20 7496 3000 |
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J&E Davy (Joint Broker) Anthony Farrell, Niall Gilchrist
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+353 (0) 1 679 6363 |
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Instinctif Partners Melanie Toyne Sewell, Rozi Morris, Tim Field
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+44 (0) 20 7457 2020
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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.
#POLB Poolbeg Pharma – Artificial Intelligence deal with OneThree Biotech
Poolbeg Pharma (AIM: POLB, ‘Poolbeg’ or the ‘Company’) a clinical stage infectious disease pharmaceutical company with a capital light clinical model, has signed an agreement with OneThree Biotech, Inc . a biology-driven artificial intelligence (‘AI’) company, to identify new drug targets and treatments for Respiratory Syncytial Virus (‘RSV’).
Under the terms of the transaction and as aligned with Poolbeg’s strategy, OneThree Biotech’s state-of-the-art AI analysis tools will identify drug assets which target immune-response pathways, have a higher probability of clinical success and have the potential to prevent and / or treat infectious diseases. The analysis will prioritise drugs with existing Phase I safety data, reducing spend and risk, which can feed into Poolbeg’s rapid, capital light clinical development strategy and its expanding pipeline of assets. The analysis is expected to commence in Q1 2022 with preliminary outputs from this work expected in H2 2022.
OneThree Biotech is a clinically validated AI company with a proven technology platform which integrates chemical, biological, and clinical data with cutting-edge computational tools to answer complex questions surrounding disease biology and drug discovery. The team at OneThree will work closely with Poolbeg’s scientific team to build a tailored AI analysis model which can leverage the unique insights of human challenge trial data to identify disease-relevant cell signalling pathways which could lead to novel drug targets. OneThree will receive milestone payments based on candidate development and royalties on the sale of products derived from this partnership.
The Company believe that this partnership with OneThree Biotech is the first time that AI analysis has been undertaken on RSV human challenge trial data and samples to identify new drug targets. The unique nature of human challenge trials to produce disease progression data with high precision is expected to revolutionise the insights generated from this analysis. Poolbeg’s lead asset POLB 001, which is progressing towards its first human challenge trial in June 2022, was identified using such disease progression data. However, by utilising AI the Company aims to identify more targets, quicker and more cost efficiently than previously possible without this technology.
Poolbeg entered a partnership with Eurofins Genomics in October 2021 to complete RNA sequencing of Poolbeg’s RSV disease progression samples from human challenge trials. This work was a key step in Poolbeg advancing its AI analysis programme. This RSV discovery dataset has been specifically designed for incorporation into OneThree’s AI platform. The data sets within this project will leverage up to 140Gb of biological data per subject spread over baseline healthy measurements and the course of infection which is expected to unveil unprecedented insights.
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 a significant public health threat affecting an estimated 50-million people annually, leading to 4 million global hospitalisations and up to 74,500 in-hospital deaths in children under the age of 5 years. An estimated 45% of these cases and deaths occur in new-born infants under the age of 6 months.
Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said:
“OneThree Biotech’s AI analysis tools will allow us to break new ground in data-driven drug discovery, by allowing us to evaluate and interrogate human challenge trial data like never before. This is a key part of our growth strategy, as we’ll be able to identify and develop drugs in a more time and cost effective manner, compared with the traditional biotech model. It will enable us to identify potential new treatments which have a higher probability of clinical success and which can feed into our rapidly expanding pipeline in-line with our capital light model.
This will be the first time that AI tools will be used to analyse RSV human challenge trial disease progression data, which illustrates the significance of this deal as well as Poolbeg’s innovative model. We look forward to updating the market on the outputs from this cutting-edge AI analysis in due course.”
Neel S. Madhukar, PhD, co-founder and CEO of OneThree Biotech , said:
“At OneThree our mission has always been to unlock new therapeutic opportunities by understanding biology on a deeper level. The ability to combine our AI platform with the data and expertise from Poolbeg Pharma will enable just that, and create an opportunity to make meaningful progress in the treatment of infectious diseases.”
Brad Pryde, co-founder and COO of OneThree Biotech , concluded:
“We have been impressed with Poolbeg Pharma’s clear dedication towards using technology and data to create efficiencies in drug discovery and development. We’re excited to demonstrate the strength of this partnership as future developments arise.”
Footnote: During a human challenge study, a number of healthy volunteers are exposed to an infectious agent in a safe and controlled quarantine setting to assess the efficacy of vaccines or treatments. Human challenge trial data is unique in the depth of longitudinal virology, health, biomarker and symptom data collected during the course of disease from pre-infection, onset, progression and resolution of an infection .
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Enquiries
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Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O’Connell, CFO
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+44 207 183 1499 |
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finnCap Ltd (Nominated Adviser & Joint Broker) Geoff Nash, James Thompson, Charlie Beeson, Richard Chambers , Sunila de Silva (ECM)
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+44 (0) 20 7220 0500 |
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Arden Partners PLC (Joint Broker) John Lewellyn-Lloyd, Louisa Waddell
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+44 (0) 207 614 5900 |
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J&E Davy (Joint Broker) Anthony Farrell, Niall Gilchrist
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+353 (0) 1 679 6363 |
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Instinctif Partners Melanie Toyne Sewell, Rozi Morris, Tim Field
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+44 (0) 20 7457 2020 |
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Little Dog Communications for OneThree Jessica Yingling, Ph.D.
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+1 (858) 344-8091 |
#POLB Poolbeg Pharma – Update on POLB 001 Clinical Development
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.
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 Melanie Toyne Sewell, Rozi Morris, Tim Field |
+44 (0) 20 7457 2020 poolbeg@instinctif.com |