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#POLB Poolbeg Pharma – Notice of Results
Poolbeg Pharma (AIM: POLB, ‘Poolbeg’ or the ‘Company’) a clinical stage infectious disease pharmaceutical company with a unique capital light clinical model , will announce its results for the period ended 31 December 2021 on Thursday 3 March 2022.
The Company will be hosting an online presentation for investors on the same day, at 6:00pm GMT on the Investor Meet Company platform.
The presentation is open to all existing and potential shareholders. Investors can register to attend here:
www.investormeetcompany.com/poolbeg-pharma-plc/register-investor
– Ends – 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, James Thompson, Charlie Beeson, Richard Chambers, Sunila de Silva (ECM)
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+44 (0) 207 220 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 |
#ORPH Open Orphan – Launch of STRiVE project
Respiratory viral strains suitable for challenge agents being collected from consenting volunteers
Open Orphan plc (AIM: ORPH), 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 hVIVO, a subsidiary of Open Orphan plc, has recently launched the STRiVE project (Seasonal Transmissible Respiratory Virus SurvEy) to collect respiratory viral strains suitable for challenge agents from consenting hVIVO employees. Collection of new respiratory viral strains circulating in the community will allow hVIVO to continually update and broaden its world leading portfolio of human challenge study models.
As part of STRiVE, volunteers with cold or flu like symptoms can send nasal swabs to hVIVO for analysis. Since starting the project, hVIVO has identified over 180 promising virus candidates that could be used in the manufacture of novel challenge agents for its human challenge trials. Viruses isolated include several strains of coronavirus, adenovirus, human metapneumovirus (HMPV), human rhinovirus (HRV), parainfluenza virus (PIV), influenza, and respiratory syncytial virus (RSV).
STRiVE ensures hVIVO can regularly update its challenge agent portfolio with relevant strains as viruses mutate over time. Manufacturing antigenically relevant strains on demand broadens hVIVO’s repository of viral pathogens and could help extend the range of human challenge models it currently offers.
The average UK adult has an estimated 2-4 respiratory infections each year, resulting in billions of pounds of lost output due to illness. Despite familiarity with the negative impacts of cold and flu viruses, remarkably little is understood about the hundreds of viruses responsible that cause illness, including transmission and markers of protective immunity. Using human challenge modelling to better understand such issues could enable future public health benefits and savings.
hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory and infectious diseases, including various strains of influenza, RSV, human rhinovirus (HRV – common cold virus), malaria, and asthma. This portfolio has also expanded to include the SARS-CoV-2 virus.
Cathal Friel, Executive Chairman of Open Orphan, said: “Despite only commencing recently, STRIVE has already been a remarkable success, with over 180 viruses identified and 12 different strains, with potential to be used as challenge agents in hVIVO human challenge trials. I would like to thank all hVIVO employees who have thus far participated and encourage more to do so in order to continue to build up this important repository for cold and flu research.
“Importantly, the STRIVE clinical research project will play a significant role in the Company’s efforts to broaden its world leading portfolio of human challenge models.”
Adrian Wildfire, Director of Scientific and Business Strategy at hVIVO, commented: “Access to viable strains of circulating respiratory pathogens is extremely limited and this often presents a significant obstacle to anyone seeking to grow a new viral challenge agent. To grow a new viral strain a virus must be collected from a human host, processed and stored in an adequate manner to keep the virus alive.
“STRIVE will allow the Company to use its expertise to monitor the viral strains of cold and flu that are circulating in the community, and potentially lead to the discovery of new, wild type challenge agents and the development of new human challenge models with unparalleled translation into the field.”
Interested in becoming a volunteer?
hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com. By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.
Individuals interested in taking part in COVID-19 human challenge study research can learn more at www.UKCovidChallenge.com.
For further information please contact:
| Open Orphan plc | +353 (0) 1 644 0007 | |||
| Cathal Friel, Executive Chairman | ||||
| Arden Partners plc (Nominated Adviser and Joint Broker) | +44 (0) 20 7614 5900 | |||
| John Llewellyn-Lloyd / Louisa Waddell | ||||
| finnCap plc (Joint Broker) | +44 (0) 20 7220 0500 | |||
| Geoff Nash / James Thompson / Richard Chambers | ||||
| Davy (Euronext Growth Adviser and Joint Broker) | +353 (0) 1 679 6363 | |||
| Anthony Farrell | ||||
| Walbrook PR (Financial PR & IR) | +44 (0)20 7933 8780 or openorphan@walbrookpr.com | |||
| Paul McManus/ Sam Allen / Louis Ashe-Jepson | +44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0) 7747 515393 | |||
#POLB Poolbeg Pharma – Confirmation of vaccine platform licence execution
31 January, 2022 – Poolbeg Pharma (AIM: POLB, ‘Poolbeg’ or the ‘Company’) a clinical stage infectious disease pharmaceutical company with a capital light clinical model, confirms that it has signed the licence to AnaBio Technologies’ (‘AnaBio’) microencapsulation and nanoencapsulation technologies to develop an oral vaccine delivery platform.
This follows the binding term sheet announced on 16 December 2021. This licence provides Poolbeg with exclusive access to AnaBio’s microencapsulation and nanoencapsulation technologies for use in the development and commercialisation of vaccines. Combined with the Company’s expertise in infectious diseases and vaccine development, Poolbeg will use this technology as a platform to complement its existing and growing pipeline of assets by developing oral vaccines for multiple disease indications.
Oral vaccines have been used successfully, but in a limited way, for decades, such as in the prevention of polio and typhoid. Broadening the range of diseases with oral vaccines available is beneficial as they can provide enhanced benefits by delivering antigens to specific areas of the gut, triggering the development of ‘mucosal immunity’ which prevents pathogens from infecting the body. The COVID-19 pandemic has accelerated demand for innovation in the development of vaccines, and oral vaccines offer many advantages having improved vaccine stability profiles, easier global distribution and administration as well as tackling the issue of needle-phobia.
This is the latest in several licence agreements that Poolbeg has completed since its IPO in July 2021, demonstrating delivery against commitments made at the time of listing. The Company’s pipeline of assets continues to expand and is increasing in diversity with the addition of this innovative oral vaccine delivery platform. This latest licencing agreement follows swiftly on the back of a series of other recently announced potentially ground-breaking infectious disease asset deals. This includes the first-in-class, intranasally administered, RNA-based immunotherapy for respiratory virus infections announced on 17 January 2022 (POLB 002). In December 2021 the Company announced that it had successful signed an option agreement to licence an intramuscular Melioidosis vaccine (POLB 003). Melioidosis is a disease which presents a dangerous and underappreciated threat to human health which currently has no approved vaccine and a very high mortality rate and in addition, concerns are growing around global warming contributing to the spread of the disease to traditionally non-tropical areas. These new assets are in addition to the Company’s lead programme, POLB 001, a treatment for severe influenza. Post-pandemic the global community recognises the importance of vaccines and treatments against infectious disease and governments are hugely increasing their investment into influenza pandemic preparedness.
Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said:
“Vaccine uptake is a critical factor in the effectiveness of combating communicable infectious diseases, something that the COVID-19 pandemic has shown in recent months. Oral vaccines bring significant benefits both in terms of the logistics required to distribute and administer them, but also in how the body responds through creating mucosal immunity in the gut and acting as a barrier to the infection.
“This licencing deal with AnaBio and the access to its advanced micro- and nano-encapsulation technologies will enable Poolbeg to develop an oral vaccine delivery platform from which to complement an already diverse pipeline of treatments and vaccines against infectious diseases.”
Aidan Fitzsimons, PhD, CEO of, AnaBio Technologies, said:
“This is a really exciting opportunity to apply AnaBio’s patented micro-encapsulation technology, which has been shown to facilitate absorption of Active Pharmaceutical Ingredients (API’s) through the gut, in the development of an oral vaccine. Micro-encapsulation is a process which involves coating microscopic particles of an API with a protective layer enabling the API to travel safely through the digestive system, and be absorbed across the gut in a bioavailable form. Combining AnaBio’s proven micro-encapsulation technology and Poolbeg’s vaccine and immunology expertise puts us both in a great position to deliver a genuine breakthrough innovation in oral vaccine development.”
– Ends –
Enquiries
| Poolbeg Pharma Plc
Jeremy Skillington, CEO Ian O’Connell, CFO
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+44 (0) 207 183 1499 |
| finnCap Ltd (Nominated Adviser & Joint Broker)
Geoff Nash, James Thompson, Charlie Beeson
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+44 (0) 20 7220 0500 |
| Arden Partners PLC (Joint Broker)
John Lewellyn-Lloyd, Louisa Waddell
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+44 (0) 207 614 5900 |
| J&E Davy (Joint Broker)
Anthony Farrell, Niall Gilchrist
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+353 (0) 1 679 6363 |
| Instinctif Partners
Melanie Toyne Sewell, Rozi Morris, Tim Field |
+44 (0) 20 7457 2020 |
#ORPH Open Orphan – New Malaria Human Challenge Model Launched
Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials announces that further to the announcement on 9 August 2021, hVIVO, a subsidiary of Open Orphan, has inoculated the first cohort of volunteers with a GMP-manufactured malaria challenge agent as part of its first controlled human malaria infection (CHMI) challenge study. This study will assess CHMI using existing standard of care antimalarial drugs against Plasmodium malaria.
The study, which is taking place at hVIVO’s state-of-the-art facilities in London, is expected to complete in Q1 2022 with results in Q2 2022. For the study, hVIVO has leveraged its extensive experience in clinical trial recruitment, via its clinical trial recruitment arm FluCamp, to identify and screen volunteers to rapidly enrol the study cohort. Following the successful completion of the study, hVIVO will be able to sign malaria human challenge study contracts to assess the efficacy of novel antimalarial drugs and vaccines as well as correlates of immunity using a Plasmodium challenge agent.
hVIVO’s Direct Venous Inoculation (“DVI”) clinical trial protocol was reviewed by all necessary UK regulatory bodies and fully approved prior to the start of the study. Expert diagnostic services from the London School of Hygiene and Tropical Medicine have been contracted to monitor the welfare of subjects and provide essential correlates relating to drug and vaccine efficacy. Additionally, comprehensive training programmes have been completed by staff and senior professional oversight put in place for the review of scientific and safety data.
This malaria challenge model consists of inoculating volunteers with purified, infectious P. falciparum (Pf) sporozoites, harvested from the salivary glands of Anopheles stephensi mosquitoes. This type of malaria challenge model has been safely used in multiple clinical trials in the United States, Europe and Africa.
Conducting malaria modelling with Plasmodium in antimalarial drug and vaccine trials has several potential advantages over traditional methods of P. falciparum infected mosquito challenge, including superior predictability, a cleaner safety profile and improved control over levels of infection.
Learn more about hVIVO’s Malaria human challenge model here www.hvivo.com/clinical-development-services/hvivo-challenge-models/malaria/ or if you are interested in participating in a Malaria human challenge study or any other human challenge study visit www.flucamp.com
Adrian Wildfire, Director of Scientific & Business Strategy at hVIVO, said: “Malaria is a disease of significant unmet need around the world, with 241 million cases and 627,000 deaths caused in 2020. Its prevention and cure is a designated World Health Organization target. As such, we are pleased to have commenced this study to allow our clinical teams to better acquaint themselves with the recently established Controlled Human Malaria Infection model, ahead of using human challenge studies to test our clients’ malaria products. Data resulting from such studies translates well into the field and malaria human challenge studies have been pivotal to the development of many of the novel drugs now entering late phase trials.”
Cathal Friel, Executive Chairman of Open Orphan, said: “We are delighted to have inoculated the first cohort of volunteers for the Malaria study at our QMB facility in London. hVIVO is fully committed to growing the malaria model’s capabilities and capacity over the coming years to meet the challenge of accelerating the introduction of novel, safe and effective drugs and vaccines to the market.
“This study also ensures that Open Orphan is both strengthening and further diversifying the Company’s world leading portfolio of viral challenge models. We look forward to updating the market in due course.”
Interested in becoming a volunteer?
hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com. By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.
Individuals interested in taking part in COVID-19 human challenge study research can learn more at www.UKCovidChallenge.com.
For further information please contact:
| Open Orphan plc | +353 (0) 1 644 0007 | |||
| Cathal Friel, Executive Chairman | ||||
| Arden Partners plc (Nominated Adviser and Joint Broker) | +44 (0) 20 7614 5900 | |||
| John Llewellyn-Lloyd / Louisa Waddell | ||||
| finnCap plc (Joint Broker) | +44 (0) 20 7220 0500 | |||
| Geoff Nash / James Thompson / Richard Chambers | ||||
| Davy (Euronext Growth Adviser and Joint Broker) | +353 (0) 1 679 6363 | |||
| Anthony Farrell | ||||
| Walbrook PR (Financial PR & IR) | +44 (0)20 7933 8780 or openorphan@walbrookpr.com | |||
| Paul McManus / Sam Allen / Louis Ashe-Jepson | +44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0) 7747 515393 | |||
#POLB Poolbeg Pharma – Poolbeg to develop oral vaccine delivery platform
16 December, 2021- Poolbeg Pharma (AIM: POLB, ‘Poolbeg’ or the ‘Company’) a clinical stage infectious disease pharmaceutical company with a capital light clinical model, has signed a binding term sheet, encompassing all commercial terms, with AnaBio Technologies (AnaBio), with a full licence and collaboration agreement to follow.
The partnership allows Poolbeg exclusive access to AnaBio’s microencapsulation and nanoencapsulation technologies, IP and expertise for oral vaccine applications. Poolbeg will utilise this technology in conjunction with its own expertise in infectious diseases, vaccine development and its associated technologies to develop an oral vaccine delivery platform. Poolbeg will also investigate using its proprietary Vaccine Discovery Platform in conjunction with this jointly developed oral vaccine delivery platform.
Oral vaccines for diseases such as polio have been used successfully for decades by delivering antigens to specific areas of the gut with the objective of stimulating ‘mucosal immunity’, which prevents pathogens infecting the body. Oral vaccines offer an efficient method of administration, reducing significant challenges for distribution and administration addressing the gaps in supplying the global community as well as addressing needle-phobia.
Microencapsulation is key to delivering drugs to the gut and results in prolonged absorption profiles. Microencapsulation also helps to ensure the right dose of a product is absorbed by the body. Preliminary data has shown that AnaBio’s platform may be combined with dual nanotechnology to create a two-step delivery process with enhanced uptake to specific cells. This technology platform can be used to encapsulate a wide range of drugs including molecules such as proteins, peptides, DNA and RNA. As a result of the pandemic, mRNA vaccines have been one of the standout success stories in the fight against COVID-19.
Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said: “As we have seen in the COVID-19 pandemic, the success of global vaccination drives is dependent on the effective uptake of vaccines. Oral vaccines are highly attractive due to their improved stability profiles, ease of administration, generation of mucosal immunity and being preferable to needle-phobic patients.
“The pharma sector is increasingly recognising that oral vaccines can act as standalone regimens or as boosters to injected vaccines which can struggle to generate mucosal immunity. By working with the experts at AnaBio and accessing its advanced micro and nano encapsulation technology, this places Poolbeg in a prime position to develop products for the oral vaccine market with vaccines for enteric (gut) and respiratory pathogens.”
Aidan Fitzsimons, PhD, CEO of, AnaBio Technologies, said: “The global pandemic has led to a major acceleration in vaccine development based on a deeper understanding of how to create and maintain immunity to disease; including the importance of mucosal immunity in addition to blood immunity. We believe that our patented microencapsulation technology designed to deliver intact active pharmaceutical ingredients (APIs) to specific sites within the body, combined with Poolbeg’s innate knowledge of viruses, could enable us together to create effective oral vaccines and make a significant impact on the vaccine market.”
– Ends –
Enquiries
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Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O’Connell, CFO
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+353 (0) 1 644 0007 |
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finnCap Ltd (Nominated Adviser & Joint Broker) Geoff Nash, James Thompson, Charlie Beeson
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+44 (0) 20 7220 0500 |
|
Arden Partners PLC (Joint Broker) John Lewellyn-Lloyd, Louisa Waddell
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+44 (0) 207 614 5900 |
|
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 |
+44 (0) 20 7457 2020 |
#ORPH Open Orphan Plc – $13.4m Influenza HCS contract win
(AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials , announces that hVIVO , a subsidiary of Open Orphan plc, has signed a $13.4m contract with a US-based biotechnology company to test its novel antiviral candidate using the hVIVO Influenza Human Challenge Study Model.
The study is expected to commence in H2 2022 and will be conducted at hVIVO’s state-of-the-art quarantine facilities in London. The Company expect the majority of revenues to be recognised in 2022.
The Company expects to sign an increasing number of contracts in this area as the global pandemic has highlighted the increased investment needed from governments and Big Pharma to develop effective, novel treatments for a range of infectious diseases that have potential to cause the next pandemic. Influenza is one such disease, with emergences of flu pandemics impossible to predict. Symptoms of influenza may be mild or cause severe disease, or in certain cases, death. 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.
hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory viruses, including various strains of influenza, respiratory syncytial virus (RSV), human rhinovirus (HRV – common cold virus), malaria, and asthma. In October 2020, this expanded to include the SARS-CoV-2 virus.
Cathal Friel, Executive Chairman of Open Orphan, said : ” We are delighted to announce this significant challenge study contract valued at over £10m, with a US-based biotechnology client testing its highly promising influenza antiviral candidate. This contract demonstrates the Company’s continued ability to convert its leading portfolio of challenge study models into substantial contracts, with signed contracts across a number of our challenge study models including RSV, asthma, hRV, and flu in the clinic next year. This underlines our market position as the world leader in the testing of vaccines, antivirals and respiratory products using human challenge trials.
“The recent emergence of the Omicron variant has illustrated the threat of pandemic infectious diseases, and as a result, pharma companies globally are looking to address the next cohort of infectious diseases which have potential to reach pandemic level, and are developing new therapeutics to help tackle them. Influenza is high on this list, and we expect to sign more contracts of this type as the infectious disease market grows exponentially in the coming years to be worth $250 billion by 2025. “
The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (as implemented into English law) (“MAR”). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.
Interested in becoming a volunteer?
hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com . By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.
Individuals interested in taking part in COVID-19 human challenge study research can learn more at www.UKCovidChallenge.com .
For further information please contact:
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Open Orphan plc |
+353 (0) 1 644 0007 |
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Cathal Friel, Executive Chairman |
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Arden Partners plc (Nominated Adviser and Joint Broker) |
+44 (0) 20 7614 5900 |
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John Llewellyn-Lloyd / Louisa Waddell |
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finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
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Geoff Nash / James Thompson/ Richard Chambers |
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Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
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Anthony Farrell |
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Walbrook PR (Financial PR & IR) |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com |
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Paul McManus/ Sam Allen/ Louis Ashe-Jepson |
+44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0) 7747 515393 |
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#ORPH Open Orphan Plc – Positive results from Flu Human Challenge Study
Open Orphan plc (AIM: ORPH) a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials, notes the announcement released from SAB Biotherapeutics (NASDAQ: SABS) (“SAB”), reporting positive results from a human challenge study testing SAB-176, its investigational therapeutic for the treatment of seasonal influenza. hVIVO, a subsidiary of Open Orphan, conducted the Phase 2a randomised, double-blinded, placebo-controlled study using its Influenza Human Challenge Study Model.
The trial evaluated the safety and treatment efficacy of SAB-176 in 60 healthy adults challenged with a pandemic influenza strain (pH1N1). Participants were intranasally inoculated with the influenza challenge virus and then randomised to receive either SAB-176 or placebo.. SAB-176 achieved statistically significant (p = 0.026) reductions in viral load. Based on partial data, statistically significant reductions in clinical signs and symptoms compared to placebo were also observed. Additionally, no serious adverse events were reported and SAB-176 appeared to be safe and well tolerated. Based on the positive results from this study, SAB plans to further evaluate SAB-176 in a Phase 2 influenza clinical trial.
Flu is caused by the influenza virus and is one of the most common infectious respiratory diseases and can lead to severe illness, and death. There are four types of seasonal influenza viruses, types A, B, C and D. Influenza A and B viruses circulate and cause seasonal epidemics of disease. According to the World Health Organisation (WHO), worldwide, these annual epidemics are estimated to result in about three to five million cases of severe illness, and about 290 000 to 650 000 respiratory deaths.
hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory and infectious disease viruses, including respiratory syncytial virus (RSV), Influenza, human Rhinovirus HRV (common cold virus), malaria, and asthma. In October 2020, this expanded to include the SARS-CoV-2 virus.
Cathal Friel, Executive Chairman of Open Orphan, said : “I am pleased that SAB has received positive results for SAB-176 from its influenza human challenge trial, conducted by hVIVO. SAB-176 met its primary endpoint and based on partial data appears to have met a key secondary endpoint. These encouraging results support proceeding to a Phase 2 clinical trial.
“Influenza affects a significant proportion of the global population every year with symptoms ranging from mild to severe, with hospitalisations and deaths occurring among high-risk groups. hVIVO has successfully been delivering Influenza human challenge trials for over two decades, and we look forward to continuing to support Big Pharma and biotechs to provide early proof-of-concept for novel vaccines and antivirals.”
Mariya Kalinova, Medical Director, hVIVO, commented: “We are delighted to see these positive results from the Phase 2a Influenza Human Challenge Study for SAB Biotherapeutics’ novel anti-influenza human immunotherapy, SAB-176. The encouraging reductions in viral load and clinical symptoms, along with the promising safety and tolerability data observed in this challenge study suggest SAB-176 may have a positive impact on individuals with influenza.
“This successful study demonstrates the way that Phase 2a challenge studies can help advance drug development and provide a value inflection point for innovative products such as SAB-176 as they move towards a full Phase 2 study. Moving forward, we expect to see an increase in the number of human challenge studies taking place across multiple infectious diseases, as interest in these disease areas continues to grow.”
For further information please contact:
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Open Orphan plc |
+353 (0) 1 644 0007 |
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Cathal Friel, Executive Chairman |
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Arden Partners plc (Nominated Adviser and Joint Broker) |
+44 (0) 20 7614 5900 |
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John Llewellyn-Lloyd / Louisa Waddell |
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finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
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Geoff Nash / James Thompson/ Richard Chambers |
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Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
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Anthony Farrell |
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Walbrook PR (Financial PR & IR) Paul McManus/ Sam Allen / Louis Ashe-Jepson |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com +44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0) 7747 515393 |
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#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 |