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

hVIVOAnnouncement

03/04/2023 07:15

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RNS Number : 5184U  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/
(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 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 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 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® platform. Cidara is
headquartered in San Diego, California. For more information, please
visit www.cidara.com
(https://www.globenewswire.com/Tracker?data=xu4JytdkqpvkoGtc4-ltSp3YskryPfTIA9zJEMV1Ld1GHxonbKjneyq3htHhGHETYn02tEKgEzTagu8I625M6Q8xPCxheT5C7d_2LVT3bqCuoXofysns4BWhsQQmrAtXtD5d4WEDYc4L67b3XazqM3AZovlcEa1-e8oz734dGWzDqMG1e_gPWC2MvcBj5cn4tpFqyTbl_rK7snHirwRYLSPwd-LShesB8G-gDdoUKKd-gvcEVJcs3lZCdVrvHlUnKlNUuQvEzzola-tx05HVJY4oNPt5FI1B-vPMTtqz6M0qom4Bi0M1b-iHk2mIMzYlci8URtZ9CcphCcPo7vrHHEwbiVKQwsSH61-Hik--eRhQ09jh8WozFt0XdtUDG8NcJtV7LNXsB2SOjHRPSADgSqp5Zhe3pXLYmwP9fKh6k8Ki1yO_FkToi7XhYmFgVJlmKdyD2cNgk2Is_e2sChzDwqmSjX4awmHhopktyGDXmixYv-IVXG1z_MSwaGwWPAlEsYKfHi2-WBpI6EewtWj-q_u98P5Ec0fVCw3FadyH0r5QR2tFQzrbhWsGfoTHFYBc08VMrkpgkQyiiGk7c24HCJH6DCeq8JQvVCcZUBLfa3MZCxqzaX4B99oWN-0RHRrYuPIuultYe_A9W_LR8m8CIjGGERBYyeB0u0eLPSPAT-E=)
.

 

 

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