RCS - hVIVO PLC - Positive results from RSV human challenge trial

hVIVOAnnouncement

07/10/2024 07:00

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RNS Number : 0032H  hVIVO PLC  07 October 2024

hVIVO plc

("hVIVO", the "Company" or the "Group")

 

Positive results from RSV antiviral human challenge trial conducted by hVIVO

Larger human challenge trial provides valuable insights for candidate
development

 

hVIVO plc (AIM: HVO), a fast-growing specialist contract research organisation
(CRO) and world leader in testing infectious and respiratory disease products
using human challenge clinical trials, notes the announcement by Enanta
Pharmaceuticals ("Enanta"), reporting positive topline results from a Phase 2a
Respiratory Syncytial Virus ("RSV") human challenge trial ("HCT") in healthy
adults conducted by hVIVO for EDP-323, its second RSV antiviral candidate.

 

EDP-323, a novel, oral, direct-acting antiviral in development for RSV
infection, has made impressive strides, achieving U.S. Food and Drug
Administration (FDA) Fast Track designation. The topline results from the HCT
involving 142 healthy adult volunteers demonstrate the effectiveness of
EDP-323. With participants split into three cohorts (47 receiving a high dose,
47 receiving a low dose and 47 receiving a placebo), the study showed that
EDP-323 was generally safe, well-tolerated, and demonstrated a rapid and
sustained antiviral effect. The results show an 85-87% reduction in viral load
area under the curve (AUC) by qRT-PCR (p<0.0001), a 97-98% reduction in
infectious viral load AUC by viral culture (p<0.0001), and a 66-78%
reduction of total clinical symptoms score AUC (p<0.0001) compared to
placebo.

 

These positive results highlight the significant role human challenge trials
play in accelerating efficacy data collection and reducing the risks
associated with later stage clinical development. With three decades of
experience and expertise in safely conducting human challenge studies, hVIVO
is proud to support groundbreaking research like this across a range of
respiratory viruses, including RSV, influenza, human rhinovirus (HRV - common
cold virus), and COVID-19. The Company looks forward to seeing continued
success for Enanta and EDP-323 in the future.

 

Enanta's full announcement is available here
(https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-announces-positive-topline-results-edp)
. EDP-323 is Enanta's second RSV candidate. Zelicapavir (EDP-938), Enanta's
first candidate, has already shown impressive results in an earlier RSV HCT
and is in later stage clinical development.

 

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: "Enanta's trial
demonstrates the depth of actionable insights a comprehensive human challenge
trial can provide. We congratulate Enanta on these impressive results, which
mark a significant step forward in the development of new medicines to treat
respiratory infections such as RSV. Achieving such positive outcomes
underscores the potential of this novel RSV treatment to make a meaningful
impact on patient care. We are proud to provide world leading human challenge
trials to support the development of exciting drug candidates which hold the
potential to have a positive impact on global health."

 

For further information please contact:

 

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

 Stephen Pinkerton, Chief Financial Officer

 Cavendish Capital Markets Limited (Nominated Adviser and Joint Broker)                                  +44 (0) 20 7220 0500
 Geoff Nash, Camilla Hume, Harriet Ward
 Nigel Birks - Life Science Specialist Sales

 Peel Hunt LLP (Joint Broker)                                                +44 (0)20 7418 8900
 James Steel, Dr Christopher Golden

 Davy (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 (mailto: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 (http://www.hvivo.com) (ticker: HVO) is a fast-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 Group has
world class challenge agent manufacturing capabilities, specialist drug
development and clinical consultancy services via its Venn Life Sciences
brand, and a lab offering via its hLAB (https://hlabservices.com/) brand,
which includes virology, immunology biomarker and molecular testing. The Group
also offers additional clinical field trial services such as patient
recruitment and clinical trial site services.

 

hVIVO runs challenge trials in London - its new state-of-the-art facilities
in Canary Wharf opened in 2024 and is the world's largest commercial human
challenge trial unit, with highly specialised on-site virology and immunology
laboratories, and an outpatient unit. To recruit volunteers / patients for its
studies, the Group leverages its unique clinical trial recruitment capability
via its FluCamp (http://www.flucamp.com/) volunteer screening facilities
in London and Manchester.

 

 

 

 

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