Open Orphan signs £10.4 million contract with global pharma client
pharmafile | August 23, 2022 | News story | Manufacturing and Production |
Open Orphan has announced that its subsidiary hVIVO has signed a £10.4 million contract with an unnamed major global pharmaceutical client, to manufacturing a new batch of H1N1 flu challenge virus, and to conduct a human challenge trial to test the client’s antiviral product.
The company said that the study would evaluate the efficacy profile of the antiviral against the specific flu subtype, generating data quickly and efficiently.
This will be the third human challenge contract signed with this major client, and the board said that this highlighted the clear benefits of human challenge trials to big pharma’s drug development process.
Good manufacturing practice (GMP)-compliant virus manufacturing activities would start immediately, and were expected to be completed by second quarter of 2023.
Following this, hVIVO will conduct a Phase IIa double-blinded placebo-controlled human challenge study, expected to be completed by the fourth quarter of 2023.
“We’re delighted to be working again with this top-five global pharmaceutical company to test its antiviral, using a new influenza strain developed by our highly experienced team,” said Open Orphan’s CEO Mo Khan. “This contract is the third challenge study with this client, and our second end-to-end full-service contract overall.”
“Influenza poses a serious global health threat, causing an estimated 290,000 to 650,000 deaths per year with significant pandemic potential, and as such, the development of new vaccines and antivirals to fight flu remains vitally important.”