Dublin and London-listed pharmaceutical services company Hvivo has signed a £2.5 million (€2.9m) contract with a mid-sized pharmaceutical company to initiate a Covid-19 characterisation study.
The manufacture of Hvivo’s Omicron BA.5 challenge agent was successfully completed in 2023. The new study aims to identify a dose of the agent that establishes a safe, measurable and reproducible disease in healthy volunteers with sufficiently high infection rates to then be able to use the model to test the efficacy of antivirals and vaccines in the future.
The company, formerly known as Open Orphan, will recruit healthy volunteers aged 18 to 30 who have previously received a full course of a licensed Covid-19 vaccine.
Characterisation studies offer numerous benefits to biopharma clients, including insights into specific pathogens that are more precise, actionable, and relevant to support and refine vaccine or antiviral development. They also provide the necessary data from which to design subsequent antiviral or vaccine efficacy testing studies.
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The study is expected to commence in the final quarter of this year, with the majority of revenue recognised in 2025.
Depending on the successful completion of the characterisation study and receipt of relevant regulatory approvals, the company expects to conduct multiple Omicron human challenge trials to test the efficacy of medical products from mid-2025.
Company chief executive Yamin “Mo” Khan said: “One of our key goals at Hvivo is to further diversify our challenge trial offerings. The establishment of a Covid challenge model is a key step to penetrating a new and expanding market, especially with regards to mucosal and multi-valent Covid vaccine development.”
Dr Andrew Catchpole, chief scientific officer of Hvivo, said: “We are excited to begin work on characterising our Omicron challenge agent, which has been made possible by our new CL3 facilities in Canary Wharf. We have leading expertise in characterising Sars-CoV-2 challenge agents having successfully conducted the world’s first Covid-19 characterisation study.
“The client funding towards this study demonstrates the strong interest and growing pipeline in this indication due to the continued risk that Covid-19, and particularly the Omicron strain, poses to global health and ongoing need for improved vaccines and treatments.”
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