RCS - hVIVO PLC - Shionogi reports positive RSV trial results

hVIVOAnnouncement

05/02/2025 07:00

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RNS Number : 9106V  hVIVO PLC  05 February 2025

hVIVO plc

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

 

Shionogi reports positive results from RSV antiviral human challenge trial
conducted by hVIVO

Human challenge trials provide valuable insights to accelerate candidate
development

 

hVIVO plc (AIM: HVO), a fast-growing early-stage Contract Research
Organisation ("CRO") and the world leader in human challenge clinical trials,
notes the announcement by Shionogi & Co., Ltd. ("Shionogi"), reporting
positive results from a Phase 2a Respiratory Syncytial Virus ("RSV") human
challenge trial ("HCT") conducted by hVIVO. The trial demonstrated a
significant reduction in viral load for Shionogi's investigational oral RSV
antiviral candidate, S-337395.

 

S-337395, which has received Fast Track designation from the U.S. Food and
Drug Administration (FDA), was evaluated in a randomised, placebo-controlled,
double-blind human challenge trial involving healthy volunteers recruited by
hVIVO's volunteer recruitment arm, FluCamp. The antiviral efficacy and safety
of S-337395 were evaluated when administered orally once daily for five days.

 

The S-337395 treatment group showed a statistically significant reduction in
viral load compared to the placebo group, achieving the primary endpoint. In
the highest dose group of S-337395, there was an 88.94% reduction in viral
load (P<0.0001), and also a statistically significant improvement in
clinical symptom scores. Additionally, S-337395 was generally safe and well
tolerated, there were no serious or severe adverse events, and no
dose-dependent increase in incidence or severity of adverse events. No
participants discontinued due to adverse events.

 

These findings reinforce the crucial role of human challenge trials in
accelerating drug development by generating rapid efficacy data, reducing risk
in later-stage trials. hVIVO has over three decades of expertise and continues
to lead in safely conducting HCTs for a range of respiratory viruses,
including RSV, influenza, human rhinovirus (HRV - common cold virus), and
COVID-19. To date, hVIVO has conducted 30 RSV challenge trials involving
approximately 2,000 healthy volunteers, expediting the development of multiple
RSV antiviral and vaccine candidates. The Company's RSV challenge model has
provided pivotal proof-of-concept data for vaccines and antivirals and has
contributed to regulatory designations, product acquisitions, and market
approvals.

 

hVIVO remains committed to advancing antiviral research through its
industry-leading human challenge models and looks forward to supporting
Shionogi in the continued development of S-337395.

 

Shionogi's full announcement is available here
(https://www.shionogi.com/content/dam/shionogi/seu/news/pdf/2025/_NP-EU-S-337395%20Shionogi%20announces%20results%20from%20RSV%20human%20challenge%20trial-%20primary%20endpoint%20reached.pdf)
.

 

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: "These results
demonstrate the power of human challenge trials in accelerating the
development of much-needed RSV treatments. The significant reduction in viral
load and improvement in clinical symptoms observed with S-337395 demonstrate
the potential of this antiviral candidate to address the urgent need for
effective RSV therapies. At hVIVO, we are proud to leverage our decades of
experience in human challenge trials to support innovative drug development,
helping to bring promising new treatments to patients faster. We look forward
to seeing continued success for Shionogi and S-337395 going forward."

 

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

 Louise Talbot - 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

 Paul McManus / Phillip Marriage /               +44 (0)7980 541 893 / +44 (0)7867 984 082 /

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

 

 

 

Notes to Editors

 

hVIVO plc (https://hvivo.com/) (Ticker: HVO) is a rapidly growing early-stage
Contract Research Organisation (CRO) and the global leader in human challenge
trials. The company delivers end-to-end clinical development services to a
diverse and expanding client base, including seven of the world's ten largest
biopharma companies.

 

hVIVO specialises in conducting human challenge trials across multiple
infectious and respiratory indications, leveraging its state-of-the-art
quarantine facility in London-the largest of its kind worldwide. The company
also offers comprehensive virology and immunology laboratory services under
the hLAB (https://hlabservices.com/) brand.

 

Through its German subsidiary, CRS (https://crs-earlyphase.com/) , hVIVO
operates a 120-bed capacity across Mannheim and Kiel, providing early-phase
clinical trial services, including first-in-human and proof-of-concept
studies. Its second subsidiary, Venn Life Sciences
(https://www.vennlifesciences.com/) , offers Early Drug Development Consulting
and Biometry services to the biopharma sector.

 

The Group provides fully integrated drug development solutions from
preclinical stages through Phase II trials, alongside patient recruitment via
FluCamp (https://flucamp.com/) . Additionally, its five clinical sites support
outpatient Phase II and III trials, ensuring a seamless and efficient pathway
from discovery to late-stage development.

 

 

 

 

 

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