REG - hVIVO PLC - £13.6m RSV antiviral contract

hVIVOAnnouncement

10/11/2022 08:30

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RNS Number : 9765F  hVIVO PLC  10 November 2022

 

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF
THE UK VERSION OF THE MARKET ABUSE REGULATION (EU) NO.596/2014, WHICH FORMS
PART OF UK LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 ("UK
MAR").

 

hVIVO plc

("hVIVO" or the "Company")

 

£13.6m RSV human challenge study contract with biopharma client

Study cohort sizes increase as clients recognise the benefits of human
challenge

 

hVIVO plc (AIM & Euronext: HVO) (formerly Open Orphan plc), 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 has signed a £13.6m contract with a
US-based biopharmaceutical client to test its respiratory syncytial virus
("RSV") antiviral candidate, using hVIVO's established RSV Human Challenge
Study Model.

 

The Phase 2a double-blinded placebo-controlled human challenge trial will
take place at the Company's specialist quarantine facilities
in Whitechapel and will evaluate the efficacy profile of the antiviral
against RSV infection. The study is expected to commence in Q3/Q4 2023, with
the revenue being recognised in 2023 and 2024. As part of the study, hVIVO
will recruit healthy volunteers via the Company's dedicated volunteer
recruitment arm, FluCamp (http://www.flucamp.com/) .

 

This contract highlights hVIVO's world leading expertise in its field and its
ability to execute sizable contracts as well as the industry's renewed focus
on developing new treatments for RSV. The Company continues to see growing
demand for larger challenge studies from both new and existing clients as they
seek greater clarity of data and pursue lower frequency endpoints in an effort
to further de-risk their programmes ahead of later stage field studies.

 

Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "We're delighted to
be working with this biopharma client to test their antiviral candidate using
our established hVIVO RSV Human Challenge Study Model. We continue to see an
increase in the size of our studies as new benefits of challenge study data
are continually realised by both new and existing biotech and pharma clients."

 

Alex Mann, Senior Director Clinical Science of hVIVO said: "RSV continues to
be a serious global health threat causing an estimated 100,000 annual deaths
in children under the age of five and we are currently seeing a significant
jump in cases around the world as we enter the winter months.

 

"This contract is a strong example of where human challenge studies can
provide great value for our clients, with access to fast, cost-effective
efficacy data which can provide a 'go/no-go' decision ahead of a larger Phase
2 study, allowing our clients to ensure that their candidates have the best
possible chance of advancing through the rest of the development pathway."

 

For further information please contact:

 

 hVIVO plc                                       +44 (0) 20 7756 1300
 Yamin 'Mo' Khan, Chief Executive Officer

 Stephen Pinkerton, Chief Financial 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, Charlie Beeson, Nigel Birks, Harriet Ward (ECM)

 Davy (Euronext Growth Adviser and Joint Broker)                           +353 (0) 1 679 6363
 Anthony Farrell, Niall Gilchrist

 Walbrook PR (Financial PR & IR)                 +44 (0) 20 7933 8780 or hvivo@walbrookpr.com

 Stephanie Cuthbert / Phillip Marriage /         +44 (0) 7796 794 663 / +44 (0) 7867 984 082 /

Louis Ashe-Jepson
+44 (0) 7747 515 393

 

Notes to Editors

 

hVIVO plc (ticker: HVO) (formerly Open Orphan plc) is a rapidly growing
specialist contract research organisation (CRO) and the world leader in
testing infectious and respiratory disease vaccines and therapeutics using
human challenge clinical trials. The Group provides end-to-end early clinical
development services to its large, established and growing repeat client base,
which includes four of the top 10 largest global biopharma companies.

 

The Group's fast-growing services business includes a unique portfolio of 10+
human challenge models to test a broad range of infectious and respiratory
disease products, world class challenge agent manufacturing, specialist drug
development and clinical consultancy services via its Venn Life Sciences
brand, and a lab offering via its hLAB brand, which includes virology,
immunology biomarker and molecular testing. The Group offers additional
clinical field trial services such as patient recruitment and clinical trial
site services.

 

hVIVO runs challenge studies in London from its Whitechapel quarantine
clinic, its state-of-the-art QMB clinic with its highly specialised on-site
virology and immunology laboratory, and its clinic in Plumbers Row. To recruit
volunteers / patients for its studies, the Company leverages its unique
clinical trial recruitment capacity via its FluCamp
(https://eur05.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.flucamp.com%2F&data=05%7C01%7CCarol.Dalton%40openorphan.com%7Cfb9f1a50aaa9492d81ed08da875cca71%7C131abc777e104bbd90170559abc5d601%7C1%7C0%7C637971129881295595%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=fQdtQTHu9Bo70yRgWcZW5liNTXPYiWl9YayUA01E%2FlA%3D&reserved=0)
 volunteer screening facilities in London and Manchester.

 

About RSV

 

RSV is the main cause of childhood lower respiratory infections and is
responsible for a significant burden of disease in the elderly and in adults
with chronic medical problems, such as COPD. Globally it affects an estimated
50-million people annually, leading to 4 million hospitalisations and
approximately 60,000 in-hospital deaths in children younger than 5 years.
There is a lack of understanding and insight into RSV disease, especially in
adult groups, despite its considerable impact on society and its high degree
of infectivity.

 

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