Positive results from RSV Human Challenge Study

RNS Number : 8868K

Open Orphan PLC

07 September 2021

 

7 September 2021

Open Orphan plc

("Open Orphan" or the "Company")

RSV Human Challenge Study conducted by hVIVO yields positive results

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 dated 1 September 2021 from Barvarian Nordic A/S (OMX: BAVA), reporting positive results received from a human challenge study testing its respiratory syncytial virus ("RSV") vaccine candidate, MVA-BN® RSV. hVIVO , a subsidiary of Open Orphan, conducted the Phase 2 double-blinded, placebo controlled trial using its RSV Human Challenge Study Model.

The trial enrolled 61 healthy adult volunteers, 18-50 years of age who were randomised to receive either a single vaccination of MVA-BN RSV or placebo. Following this, volunteers were challenged intranasally with an RSV type A strain 28 days. The study demonstrated a significant reduction in viral load in vaccinated subjects (n=30) versus placebo (n=31), thus meeting the primary endpoint of this pivotal study. At the same time, the vaccinated subjects showed a significant reduction in clinical symptoms typically associated with RSV infections. The MVA-BN RSV vaccine demonstrated a vaccine efficacy of up to 79% in preventing symptomatic RSV infections. No vaccine-related serious adverse events were observed, and the vaccine was well tolerated, consistent with the safety profile previously reported in Phase 1 and Phase 2 clinical studies.

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 and is one of the leading causes of hospitalisation to at-risk older adults. Among the elderly (aged 65+), RSV causes as many hospitalisations and deaths as influenza (source: CDC). In the current climate, RSV may also lower immunity and increase the risk of developing COVID-19, and where these infections occur together, it can worsen the severity of COVID-19 illness. There is currently no vaccine on the market for RSV.

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.

Cathal Friel, Executive Chairman, said: "We are delighted to see the positive results emerge from this RSV Human Challenge Study with Bavarian Nordic for its RSV vaccine candidate, which was run by hVIVO. This Study illustrates the Company's diverse offering across the infectious disease market.

"We are the only company in the world that is currently equipped to run RSV challenge studies, which forms part of our wider portfolio of respiratory and infectious disease challenge trials. With the global infectious disease market expected to reach a value of $250bn by 2025, we are already seeing a huge increase in interest across the entire pharmaceutical and biotech space in these previously underserved infectious disease areas. We look forward to offering our industry leading services to help novel therapeutics and vaccines progress through clinical development."

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				[phone]
Cathal Friel, Executive Chairman
Arden Partners plc (Nominated Adviser and Joint Broker)				[phone]
John Llewellyn-Lloyd / Louisa Waddell / Oscair McGrath
finnCap plc (Joint Broker)				[phone]
Geoff Nash / James Thompson/ Richard Chambers
Davy (Euronext Growth Adviser and Joint Broker)				[phone]
Anthony Farrell
Walbrook PR (Financial PR & IR)	[phone] or [e-mail]
Paul McManus/ Sam Allen/ Louis Ashe-Jepson			[phone]/ [phone] / [phone]

Notes to Editors

Open Orphan plc (London and Euronext: ORPH) is a rapidly growing pharmaceutical service/contract research company that is a world leader in testing vaccines and antivirals using human challenge clinical trials. The company provides services to Big Pharma, biotech and government/public health organisations.

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic, opened in February 2021, and its 24-bedroom QMB clinic with its highly specialised on-site virology and immunology laboratory. Open Orphan has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of other models including the world's first COVID-19 human challenge study model as part of the Human Challenge Programme.

Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company's Disease in Motion® platform, this unique dataset includes clinical, immunological, virological and digital (wearable) biomarkers. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies. Following COVID-19 there is now a renewed interest and investment in infectious diseases.

Open Orphan's Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company's Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact [e-mail] or visit www.rns.com.

Reach is a non-regulatory news service. By using this service an issuer is confirming that the information contained within this announcement is of a non-regulatory nature. Reach announcements are identified with an orange label and the word "Reach" in the source column of the News Explorer pages of London Stock Exchange's website so that they are distinguished from the RNS UK regulatory service. Other vendors subscribing for Reach press releases may use a different method to distinguish Reach announcements from UK regulatory news.

 

END

 

 

NRADKABBPBKDQCK