Hvivo, a pharmaceutical services company listed on the Dublin and London stock exchanges, has secured a £2.5 million (€2.9m) contract with a mid-sized pharmaceutical company to start a Covid-19 characterisation study. In 2023, Hvivo successfully completed the manufacture of its Omicron BA.5 challenge agent. The upcoming study aims to determine a dose of this agent that induces a safe, measurable, and reproducible disease in healthy volunteers, achieving high infection rates necessary for testing the efficacy of antivirals and vaccines in the future.
Recruitment for the study will target healthy volunteers aged 18 to 30 who have received a full course of a licensed Covid-19 vaccine. Characterisation studies provide biopharma clients with precise, actionable insights into specific pathogens, supporting and refining vaccine or antiviral development. They also generate crucial data needed for designing subsequent antiviral or vaccine efficacy testing studies.
The study is set to begin in the final quarter of this year, with most of the revenue to be recognised in 2025. Subject to successful completion and regulatory approvals, Hvivo anticipates conducting multiple Omicron human challenge trials to test medical product efficacy from mid-2025.
Yamin “Mo” Khan, Hvivo’s chief executive, highlighted the company’s goal to diversify its challenge trial offerings. Establishing a Covid challenge model is seen as a critical step in accessing a new and expanding market, particularly for mucosal and multi-valent Covid vaccine development.
Dr Andrew Catchpole, chief scientific officer of Hvivo, expressed excitement about characterising the Omicron challenge agent, facilitated by the company’s new CL3 facilities in Canary Wharf. He emphasised Hvivo’s leading expertise in characterising Sars-CoV-2 challenge agents, noting their successful conduct of the world’s first Covid-19 characterisation study. The client’s funding for this study underscores the strong interest and growing pipeline in this area, driven by the ongoing global health threat posed by Covid-19, especially the Omicron strain, and the need for improved vaccines and treatments.
hVIVO plc (formerly Open Orphan plc), led by Cathal Friel, is a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease vaccines and antivirals using human challenge clinical trials, providing end-to-end early clinical development services for its broad and long-standing client base of biopharma companies.
