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#ORPH Open Orphan PLC – Positive results from RSV Human Challenge Study
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, notes the announcement dated February 17 2022 from Enanta Pharmaceuticals, Inc . (NASDAQ: ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, on positive results from a human challenge study assessing its respiratory syncytial virus (“RSV”) antiviral candidate, EDP-938. The results from this human challenge study have been published in TheNew England Journal of Medicine. hVIVO , a subsidiary of Open Orphan, conducted the Phase 2a, double-blind, placebo-controlled trial using its RSV Human Challenge Study Model.
The trial enrolled 178 healthy adult volunteers across two parts, 18-55 years of age, who were intranasally challenged with RSV-A Memphis 37b (“M37b”). Volunteers received either a dose of EDP-938 or placebo for five days after infection, with different dose levels of EDP-938 being assessed. The study demonstrated that both viral load and clinical symptoms were significantly lower in volunteers that received EDP-938 than those that received placebo, with similar safety profiles between placebo and the antiviral regimens. Importantly, no serious adverse events occurred.
RSV is a contagious, common respiratory virus that usually causes mild, cold-like symptoms and 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 and is one of the leading causes of hospitalisation to at-risk older adults.
hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory and infectious disease viruses, including various strains of influenza, RSV, HRV, asthma and malaria, etc.
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO said: ” It’s pleasing to see another of our clients getting such positive results from a human challenge study that we conducted, and that the data has been published in The New England Journal of Medicine. EDP-938 is a potentially important medicine that could help reduce the global impact of RSV, and I look forward to following Enanta’s continued progression of the candidate through further clinical trials.”
Cathal Friel, Executive Chairman of Open Orphan, said : “We are delighted to see that this important Phase 2a study of EDP-938 has yielded such positive results. We are a world leader in testing infectious and respiratory disease products using challenge studies such as this, and RSV is just one portion of our portfolio of challenge models, which also includes influenza, HRV, malaria, asthma, and now SARS-CoV-2. We look forward to continue offering our world class services to partners as we look to meet the growing demand from the infectious disease market.”
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 |
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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 – 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 | |||
Experts seek approval for COVID-19 trials – China Daily
By ANGUS McNEICE in London
Medical community divided on issue of exposing humans to deadly virus
A laboratory in the United Kingdom is hoping to become the first in the world to intentionally infect volunteers with novel coronavirus in order to test the efficacy of COVID-19 vaccines.
Half of the participants in these so-called human challenge trials would be given a candidate vaccine for COVID-19, the other half would get a placebo, and all of them would then be exposed to novel coronavirus via a nasal spray.
The volunteers, aged 18 to 30, would then spend weeks quarantined at a private clinic, frequently checked on by researchers in hazmat suits running tests to determine if the vaccine provides protection against the disease. Those who display symptoms would be treated with antivirals or immunotherapeutics.
The human challenge model is a tried and tested way to assess vaccine efficacy. Such trials have previously been used in the study of influenza, malaria, typhoid, dengue fever, and cholera inoculations. Challenge studies have an advantage over traditional field trials when levels of a pathogen are low in the general population, as is the case with novel coronavirus during lockdown.
The method is also highly controversial, and the lab in question, London-based hVIVO, will have to navigate an ethical minefield to achieve its goal during this pandemic.
“We are the only place in the world that is well down the road to development for COVID-19 human challenge studies,” Cathal Friel, chief executive of hVIVO parent company Open Orphan, told China Daily. “We will be able to very quickly guarantee to any pharma company in the world if their vaccine works.”
Friel is currently in talks over running challenge trials for a dozen COVID-19 vaccine developers in Europe, North America, and Asia, three of which are from China. Before commencing the trials, hVIVO must gain approval from the ethics committee at the UK’s drug regulator, the Medicines and Healthcare products Regulatory Agency.
Among a host of considerations, the committee will attempt to answer two core questions: is COVID-19 too dangerous for a challenge trial, and are existing treatments effective enough if and when volunteers fall ill.
Challenge trials generally involve around 100 volunteers and are typically used to test vaccines against non-lethal illnesses, such as the common cold, or diseases for which highly effective treatments exist, such as malaria. The trials are not considered for lethal diseases for which existing treatments are limited, such as Ebola or Marburg virus.
While severe cases of COVID-19 are rare among healthy young people, some in the medical community warn that not enough is yet known about the disease to run such trials, and doing so would be extremely risky. Others argue that this risk can be mitigated with well-designed trials, which would in turn greatly accelerate vaccine development, potentially saving hundreds of thousands of lives.
Vaccine developers are faced with a conundrum during this stage of the pandemic. Field trials involving tens of thousands of volunteers are most efficient when a pathogen is thriving in the general population. But lockdown measures in some regions have been so effective that there is not enough COVID-19 going around to challenge a vaccine’s efficacy.
Link here to the original story