Open Orphan’s (ORPH ) hVIVO has signed a £5.1m contract to test its Investigational Medicinal Product (IMP) using its respiratory syncytial virus (RSV) Human Challenge Study Model.
hVIVO, a subsidiary of the specialist contract research organisation (CRO), Open Orphan, has signed the £5.1m contract with a biopharmaceutical company that remains unnamed.
The medical laboratory division will conduct the study on behalf of its biopharmaceutical client to demonstrate the efficacy of its IMP against RSV infection. The study is due to commence in 2H22, with the revenue from the contract being recognised across 2021 and 2022, it noted.
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, according to The Centers for Disease Control and Prevention (CDC).
Open Orphan said RSV may 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.
hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory viruses, including RSV, various strains of Influenza, human Rhinovirus HRV, malaria, and asthma. In 2020, this expanded to include SARS-CoV-2.
Cathal Friel, Executive Chairman of Open Orphan said: “We are pleased to have signed this contract to test our client’s product using our RSV Human Challenge Study Model. It is testament to our position as the world leading provider of Phase IIa human challenge study clinical trials that innovative biopharmaceutical companies, as well as Big Pharma, are actively and regularly engaging us to test their novel vaccine and antiviral candidates.”
He added, “RSV is one of several infectious and respiratory disease areas of unmet need that we are seeing rapidly growing interest in from drug developers. We look forward to working with more companies across the world to test their antivirals and vaccines, as Phase IIa human challenge studies increasingly become part of mainstream clinical trial design.”
In September 2021, Open Orphan received positive results from a human challenge study conducted by hVIVO testing its respiratory syncytial virus 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. Its aim is to develop a vaccine for the respiratory virus RSV, a disease for which there is currently no vaccine on the market.
The Phase 2 trial enrolled 61 healthy adult volunteers between 18-50 years of age who were randomised to receive either a single vaccination of MVA-BN RSV or a placebo. Following this, the volunteers were challenged intranasally with an RSV type A strain 28 days.
Overall, 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 study, it reported.
The candidates also showed a significant reduction in clinical symptoms typically associated with RSV infections. RSV affects the respiratory tract of children and at-risk older adults; in severe cases, it can cause pneumonia and other life-threatening breathing difficulties.
In August 2021, hVIVO signed an £8.1m contract with a major global pharmaceutical firm to test its inhaled human rhinovirus (hRV) antiviral product. The bulk of the revenue from this contract is to be recognised across 2021 and 2022.
Under the terms of the agreement, hVIVO will test the antiviral product using its asthma human challenge study model, which uses a hRV challenge agent (common cold virus). It said this antiviral study will be conducted by hVIVO and is expected to commence 1H22.
Currently, 5.4 million people in the UK receive treatment for asthma, and illnesses such as the common cold, which is most commonly caused by HRV, can worsen symptoms.
In a research note, analysts at Arden Partners said the contract win reflects “the increasing value and breadth of challenge study contracts that the Group is pursuing and winning.”
In our view, the stock’s sharp pullback in recent months represents a strong buying opportunity when considering the ongoing COVID and related infectious diseases issues.”
The Group said the contract underlines the increased international focus and investment into respiratory and infectious diseases following the pandemic, in areas previously underserved by the pharmaceutical industry including, interia alia, the common cold and flu.
Analysts also pointed to the broader investment opportunity in the infectious disease space. Commenting on this latest asthma challenge model contract win, Arden said Open Orphan was “beginning to monetise the broad range of IP within the challenge model portfolio.”
In terms of market scope, analysts explained: “The lack of investment in infectious diseases by large pharma in recent years indicates that R&D should expand to $250b by 2025 according to the press release, representing a huge growth opportunity for Open Orphan.”
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