Shares of Open Orphan PLC (LON: ORPH) today surged 6.2% after the company received approval to run the first human clinical trials of Codagenix’s intranasal COVID-19 vaccine candidate from the UK's independent Medicines and Healthcare Products Regulatory Agency (MHRA).
Today’s announcement marks a significant milestone for Open Orphan, whose hVIVO subsidiary inked a deal with Codagenix Inc. a US biotech company in July to run the Phase I study of COVI-VAC, which was yet to receive regulatory approval.
COVI-VAC is one of the few vaccines that use the live-attenuated virus (i.e. the entire virus in a weakened form), unlike most other vaccines which only contain the viral spike. The vaccine also does away with injections as it is administered as a single intranasal dose.
The study is expected to kick off in January 2021 and will involve 48 healthy young adult volunteers, and will be conducted at hVIVO's 24-bedroom quarantine clinic located in Whitechapel, East London.
Cathal Friel, Open Orphan’s Executive Chairman, said:
“We are delighted to have MHRA approval to begin recruiting volunteers for this much needed clinical trial. The volunteers who attend our unique quarantine facility in East London are expertly supervised in a safe, controlled clinical environment and could be contributing to the development of a new breakthrough vaccine candidate that has the potential to confer immunity to individuals over a much longer timescale.”
“We hope to demonstrate safety and immunogenicity through this trial, which will then allow us to support Codagenix as they move into a larger Phase II / Phase III programme.”
Open Orphan share price
Open Orphan shares today surged 6.2% to trade at 24p having rallied from Friday’s closing price of 22.6p.