Hvivo, a pharmaceutical services company listed in Dublin and London, has inked a contract valued £2.5 million (€2.9 million) with an intermediate pharmaceutical firm to kickstart a Covid-19 characterisation investigation. This follows the successful production of Hvivo’s Omicron BA.5 challenge element in 2023.
The objective of the new study is to pinpoint a dose of the agent that produces a safe, quantifiable and repeatable disease in healthful volunteers with adequately high infection rates for future testing of the agent’s effectiveness against antivirals and vaccines. The aim is to recruit 18 to 30 years old healthy volunteers that have already had a complete series of a licensed Covid-19 vaccine for the study, which used to be referred to as Open Orphan.
The characterisation studies extend many benefits to biopharmaceutical clients, such as precise, actionable, and relevant insights into specific pathogens for supporting and refining vaccine or antiviral development. It also provides the required data to design subsequent antiviral or vaccine efficiency testing investigations.
It’s predicted that the study will begin in the final quarter of this year with most revenue acknowledged in 2025. On the successful wrapping up of the characterisation investigation and receipt of related regulatory permissions, the firm is hoping to implement several Omicron human challenge trials from mid-2025 to test the success of medical goods.
Yamin ‘Mo’ Khan, CEO of Hvivo, mentioned that a key objective at Hvivo is to broaden their challenge trial offerings. He added that creating a Covid challenge model is essential for penetrating an emerging and expanding marketplace, especially for the development of mucosal and multi-valent Covid vaccines.
Dr Andrew Catchpole, chief scientific officer of Hvivo, expressed excitement to start working on characterising their Omicron challenge agent, thanks to their new CL3 facilities in Canary Wharf. He mentioned their leading expertise in characterising Sars-CoV-2 challenge agents, having successfully carried out the world’s first Covid-19 characterisation investigation. The funding for this investigation proves the growing interest and pipeline in this field due to the sustained global health risk posed by Covid-19, especially the Omicron strain, and the persistent need for enhanced vaccines and treatments.