hVIVO plc

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

RSV human challenge trial contract signed with new client, Inhalon Biopharma

Highlights

·    hVIVO RSV human challenge trial to test IN-002, an inhaled (mucosal) antiviral candidate to treat RSV infection

·    FluCamp to recruit healthy volunteers to test IN-002 efficacy across three dosing levels

·    Trial expected to commence in H2 2026 with the majority of revenue recognised in 2026

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, announces that it has signed a contract with Inhalon Biopharma, Inc. ("Inhalon"), a clinical-stage company advancing a first-in-class inhaled antibody platform for treating acute respiratory infections, to assess its inhaled IN-002 antiviral candidate ("IN-002") using the hVIVO Respiratory Syncytial Virus (RSV) Human Challenge Model.

The Phase 2a randomised, double-blinded placebo-controlled human challenge trial will evaluate the safety, pharmacokinetics and antiviral activity of inhaled IN-002 following RSV infection, at three dose levels. hVIVO will leverage its in-house volunteer recruitment arm, FluCamp, to enrol healthy volunteers into the study. The study is expected to commence in H2 2026 at hVIVO's state-of-the-art quarantine facilities in Canary Wharf, with the majority of revenue expected to be recognised in 2026.

IN-002 uses Inhalon's patented drug delivery platform, with its direct inhaled delivery into the lung showing potential to be significantly more effective for combating RSV infections. Early data from human clinical studies with other Inhalon candidates indicates patients may benefit from swift recovery of symptoms with rapid control of inflammation. For infants and young children suffering from RSV, IN-002's inhaled dosing offers greater comfort and ease of delivery, with the potential to shift treatment of respiratory infections to an at home "test-and-treat" approach.

Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "We previously identified the next generation of vaccines and antivirals, including mucosal-based delivery systems, as being a key growth driver for our challenge trial business. The contract win strengthens our longer term orderbook, adding to visibility into 2026. Inhalon's IN-002 and its innovative delivery platform could provide a novel way to combat RSV infections. The study is also notable for including three dosing arms - further supporting the trend of biopharma companies looking to obtain greater actionable insights into their candidates earlier to help inform later-stage field trials."

John Whelan, President and Chief Executive Officer of Inhalon, said: "We look forward to working with hVIVO on this Phase 2a study of our inhaled IN-002 antiviral candidate for RSV. Because preventive vaccines are underutilized, RSV and other respiratory infections continue to pose a significant risk to public health. There remains an unmet need for novel therapeutics that can treat underlying respiratory diseases counteracting severe illness, particularly in vulnerable populations such as infants, toddlers, and the elderly. Inhalon's inhaled antibody treatment approach not only targets the underlying pathophysiology of RSV and other respiratory infections, it also provides painless, self-administration by patients in their own homes, potentially reducing hospitalizations."

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Notes to Editors

hVIVO plc (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 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 volunteer screening facilities in London and Manchester.

About Inhalon Biopharma

Inhalon Biopharma, Inc., is a private, clinical-stage company advancing a proprietary inhaled antibody platform for treating a variety of acute respiratory infections. Inhalon Biopharma's intellectual property includes approved U.S. and EU patents covering the composition and use of aerosolized muco-trapping antibodies. Inhalon Biopharma is supported by the Thiel Foundation's Breakout Labs, Cambrian Growth Partners, Berkeley Catalyst Fund, JSR Life Sciences and Life Science Angels, as well as several federal grants from the NIH and USAMRDC.

About RSV

RSV remains a leading cause of childhood lower respiratory infections and is responsible for a significant burden of disease in the elderly and in adults with chronic medical problems. Globally RSV affects an estimated 33 million people annually, leading to approximately 4 million hospitalisations and approximately 101,000 RSV-attributable deaths in children under five years.¹ Even with a number of RSV vaccines approved in recent years, there remains a considerable unmet need for effective antivirals that address acute disease which continues to have a major impact on vulnerable populations worldwide.

1 Li Y et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis. Lancet. 2022 May 28;399(10340):2047-2064. doi: 10.1016/S0140-6736(22)00478-0. Epub 2022 May 19. PMID: 35598608; PMCID: PMC7613574.