RCS - hVIVO PLC - Positive results from flu human challenge study

hVIVOAnnouncement

05/10/2023 07:00

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RNS Number : 7334O  hVIVO PLC  05 October 2023

hVIVO plc

("hVIVO" or the "Company")

 

Positive results from influenza human challenge study conducted by hVIVO

 

Pneumagen to advance antiviral candidate into further clinical studies

 

hVIVO plc (AIM & Euronext: HVO), the world leader in testing infectious
and respiratory disease products using human challenge clinical trials, notes
the announcement
(https://www.pneumagen.com/pneumagen-announces-successful-clinical-proof-of-concept-for-its-broad-spectrum-antiviral-neumifil-in-phase-2-influenza-human-challenge-study/)
by Pneumagen, a clinical-stage biotech company, reporting successful clinical
proof of concept for its broad-spectrum antiviral candidate Neumifil,
demonstrated from a Phase 2a influenza human challenge study conducted by
hVIVO.

 

The randomised, double-blind, placebo-controlled study enrolled 104 healthy
adult volunteers, recruited through the FluCamp (http://www.flucamp.com)
platform, and evaluated two dose regimens of Neumifil, administered as an
intranasal spray to participants who were subsequently infected with influenza
virus.

 

Based on these positive clinical results, taken together with a pre-clinical
data package demonstrating Neumifil's activity against a broad range of
viruses, Pneumagen now plans to advance Neumifil into further clinical
studies. This will include the evaluation of Neumifil's ability to reduce the
incidence of viral induced exacerbations in patients with Chronic Obstructive
Pulmonary Disease ("COPD").

 

Neumifil demonstrated a clinically significant reduction in the incidence of
symptomatic influenza infection and in the severity of symptoms, which
achieved statistical significance compared to placebo. Neumifil was well
tolerated with no new emergent adverse events or safety signals from the study
compared to its first in human study.

 

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: "We are
delighted to see Pneumagen obtain these results clearly achieving clinical
proof of concept for Neumifil, which has supported Pneumogen's decision to
progress the candidate into further clinical studies, including in patients
with COPD. This is another example of the value of human challenge trials in
delivering clinical efficacy data and de-risking later clinical development."

 

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

 Cavendish Capital Markets Limited (Joint Broker)                          +44 (0) 20 7220 0500
 Geoff Nash, Charlie Beeson, Nigel Birks, Harriet Ward

 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

 

About hVIVO

 

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 11
human challenge models, with a number of new models under development, to test
a broad range of infectious and respiratory disease products. The Company has
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 capability 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.

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