hVIVO PLC Positive results from flu human challenge study
April 03 2023 - 1:00AM
RNS Non-Regulatory
TIDMHVO
hVIVO PLC
03 April 2023
hVIVO plc
("hVIVO" or the "Company")
Positive results from influenza human challenge study conducted
by hVIVO
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, notes the
announcement by Cidara Therapeutics, Inc. ("Cidara"), reporting
positive interim results from an ongoing human challenge study
testing CD388. hVIVO is conducting the Phase 2a single-center,
randomised, double-blinded, placebo-controlled trial using its H3N2
Influenza Human Challenge Study Model.
CD388 is Cidara's long-acting drug-Fc conjugate antiviral for
the treatment of seasonal influenza. The interim analysis is based
on 56 healthy volunteers, with 28 receiving a single dose of CD388
(150 mg) and 28 receiving a placebo. All subjects were then
challenged with a H3N2 influenza A challenge agent. Interim results
showed a decrease in viral replication in the upper respiratory
tract and influenza infection in participants receiving a single
dose of CD388 when compared to placebo. CD388 was well-tolerated
with no drug -related adverse events observed. The data has
established preliminary clinical proof of concept for CD388's
ongoing development programme.
hVIVO has three decades of experience and expertise in safely
conducting challenge studies across a range of respiratory viruses,
including various strains of influenza, respiratory syncytial virus
(RSV), human rhinovirus (HRV - common cold virus), COVID-19,
asthma, as well as malaria.
Cidara's announcement is available at
https://www.cidara.com/news/cidara-therapeutics-announces-promising-interim-phase-2a-data-assessing-the-safety-and-efficacy-of-a-single-dose-of-cd388-in-an-influenza-challenge-model/
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said:
"hVIVO boasts a world-leading portfolio of human challenge models,
and we are delighted to see the positive interim results outlining
CD388's efficacy against H3N2 influenza, one of the two subtypes
responsible for the annual influenza epidemics. The results are
another clear demonstration of the value of human challenge trials
in delivering quick efficacy data, de-risking entry into later
stage clinical development. Importantly, the data underlined the
potential of Cidara's Cloudbreak drug-Fc conjugates, of which CD388
is one example, to be efficacious long-acting therapeutics with
universal protection of seasonal and pandemic influenza."
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 +44 (0) 7796 794 663 / +44 (0) 7867 984
Marriage / 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 capacity via its FluCamp volunteer screening facilities
in London and Manchester.
About Cidara Therapeutics
Cidara is developing long-acting therapeutics designed to help
improve the standard of care for patients facing serious diseases.
The Company's portfolio is comprised of new approaches aimed at
transforming existing treatment and prevention paradigms, first
with its lead Phase 3 antifungal candidate, rezafungin, in addition
to drug-Fc conjugates (DFCs) targeting viral and oncology diseases
from Cidara's proprietary Cloudbreak(R) platform. Cidara is
headquartered in San Diego, California. For more information,
please visit www.cidara.com.
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