Open Orphan launches world’s first human coronavirus challenge study

Clinical research organisation (CRO) Open Orphan has begun the world’s first commercial human coronavirus challenge study model.

The study, also known as a Controlled Human Infection Model (CHIM), will aim to help guide and test the efficacy of new and existing vaccines for Covid-19, through the generation of fast, proof-of-concept data against the Coronavirus family.

Human challenges studies have participants deliberately exposed to infectious agents in order to advance the development of drugs and vaccines.

Open Orphan’s human challenge model is being led the company’s subsidiary hVIVO and builds upon work to potentially develop a Coronavirus challenge study several years ago.

Utilising common Coronavirus strains such as OC43 and 229E, the study will aim to generate data that helps inform an effective selection of best candidates and the products that should be fast-tracked for field testing against Covid-19. Strains such as OC43 and 229E have been widespread in the community for a number of years and cause only a mild-like respiratory illness. More so, hVIVO has stated that these common coronaviruses have safely be administered to volunteers in the trial.

The test will take place in Europe’s only 24-bedroom quarantine clinic with onsite virology lab where the challenge model will be developed and used. The company hopes to secure the majority of development costs through Chinese pharmaceutical partner companies, who will get a return on their investment from royalties on the sale of the challenge study model.

Once developed, hVIVO will offer its coronavirus challenge study model as both a standalone service to customers or as part of a combined Phase 1 and human challenge study that can both be run out of its London quarantine clinic. Furthermore, hVIVO can also offer services in early phase vaccine development.

Cathal Friel, executive chairman of Open Orphan, commented: “This is an important milestone in the development and evolution of Open Orphan and particularly the Company’s subsidiary hVIVO which is based in London, UK. We are very happy to be able to try and assist in the battle against Covid-19. Our hVIVO scientists and virologists, and especially hVIVO’s founder and the now chairman of our Scientific Advisory Board professor John Oxford, have a long history and experience of successfully developing challenge studies.

This development also reinforces the strength of hVIVO’s reputation as a world leader in providing services to global vaccine and anti-viral production companies and is another example of the growth potential for Open Orphan. A considerable amount of the work around this project has already been carried out and the project takes advantage of the significant knowledge and experience gained from hVIVO’s previous challenge virus manufacturing campaigns. We are delighted to be working with Mike Wang of the international law firm King & Wood Mallesons who is working with us to secure funders for this project from his network of Chinese pharmaceutical and life science companies."