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#ORPH Open Orphan – PLC Notice of results

open orphan

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 it will release its interim results for the six months ended 30 June 2022 on 8 September 2022. 

 

Investor presentation

 

Yamin ‘Mo’ Khan, Chief Executive Officer, and Leo Toole, Chief Financial Officer, will provide a live presentation relating to the interim results via the Investor Meet Company platform on 8 September 2022 at 18:00 BST.

The presentation is open to all existing and potential shareholders. Questions can be submitted pre-event via your Investor Meet Company dashboard up until 9am the day before the meeting or at any time during the live presentation.

Investors can sign up to Investor Meet Company for free and add to meet Open Orphan here. Investors who already follow Open Orphan on the Investor Meet Company platform will automatically be invited.

 

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Yamin Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

 +44 (0) 20 3100 2000

Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King

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)

Stephanie Cuthbert / Phillip Marriage /
Louis Ashe-Jepson

+44 (0)20 7933 8780 or  openorphan@walbrookpr.com

+44 (0) 7796 794 663 / +44 (0) 7867 984 082 /
+44 (0) 7747 515 393

#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

 

+44 (0) 207 183 1499
finnCap Ltd (Nominated Adviser & Joint Broker)

Geoff Nash, James Thompson, Charlie Beeson

 

+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

#POLB Poolbeg Pharma – Poolbeg Pharma licences first-in-class broad spectrum RNA-based immunotherapy for respiratory virus infections from the University of Warwick

17 January, 2022- Poolbeg Pharma (AIM: POLB, ‘Poolbeg’ or the ‘Company’), a clinical stage infectious disease pharmaceutical company with a capital light clinical model, has in-licenced a novel, first-in-class RNA-based immunotherapy for respiratory virus infections developed at the University of Warwick.

Poolbeg has secured an exclusive licence to this dual antiviral prophylactic and therapeutic candidate, which is at a late-pre-clinical development stage. In vivo data confirms that this immunotherapy asset targets pan-respiratory virus infections, which could include influenza, respiratory syncytial virus (RSV), SARS-CoV-2 and others.

The candidate, which will be developed by Poolbeg as POLB 002, was developed at the University of Warwick and derived from twenty years of research with world class virologists, Professor Andrew Easton and Professor Nigel Dimmock.

Administered intra-nasally, this RNA-based immunotherapy works by triggering nasal cells into an antiviral state to protect from the infecting virus. Simultaneously, it blocks the cells from making more virus by directly preventing its replication. Both modes of action combined can reduce infectious viral loads and improve disease symptoms. As a nasally administered and rapidly effective prophylactic antiviral candidate, it could potentially provide an effective solution for protecting at risk patient populations (e.g. the elderly, COPD patients, and asthmatics).

Respiratory virus infections are considered a top five global killer resulting in more than three million annual deaths worldwide. There is a significant unmet need for improved respiratory virus infection therapies and the current available treatments, vaccines and antiviral drugs, are typically pathogen specific. Consequently, 85% of illnesses caused by non-influenza viruses cannot be adequately treated and the emergence of resistance is also a major concern.

Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said: “This dual action immunotherapy developed by the team at University of Warwick is a really exciting technology in the field of respiratory virus disease treatments. The data shows it to rapidly reduce viral load and also prevent the likelihood of virus resistance.

“It will be an excellent addition to our growing pipeline of assets and we plan to move rapidly towards human proof-of-concept studies using our capital light clinical model. We look forward to updating the market as POLB 002 progresses through the clinic with the ultimate aim of partnering it with Big Pharma.”

Professor Andrew Easton, from the School of Life Sciences at the University of Warwick, said: “Currently most respiratory virus infections cannot be treated despite being responsible for millions of deaths each year. This is a very exciting new approach with great potential. We are delighted to be developing it alongside the Poolbeg Pharma team, with their extensive knowledge and experience in the sector.”

– 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

 

+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

 

University of Warwick
Alice Scott – Media Relations Manager

+44 (0) 7920 531 221

Alice.j.scott@warwick.ac.uk

 

#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

 

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 

 

+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

#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:

 

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)

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 

#ORPH Open Orphan – Why scientists are deliberately infecting volunteers with Covid-19

If you are going to catch covid-19, jokes Jacob Hopkins, a university student, the safest place to do it is in a hospital. So in March Mr Hopkins lay down on a bed in the Royal Free Hospital in London while doctors placed droplets of liquid carrying the sars-cov-2 virus into his nose. Mr Hopkins was one of 36 participants in the first “human challenge trial” (hct) for covid-19.

Human trials are a valuable part of medical research. Studying sick people in the controlled environment of a lab allows scientists to collect valuable information about how diseases work much more quickly than relying on messy and uncertain data from the real world. Since the second world war, around 40,000 volunteers have allowed themselves to be infected with everything from malaria and typhoid to dengue fever and cholera.

Read the full Economist article here.
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