Dublin-listed pharmaceutical services company Open Orphan has signed a new deal with New York-based Codagenix for the phase one trial of a new Covid-19 vaccine.
The trial, which will evaluate the safety and ability of the vaccine to evoke a repulsions in the immune system, will look at 48 healthy young adult volunteers.
The vaccine is a single-dose, intranasal candidate, and will be trialled at Open Orphan subsidiary Hvivo’s quarantine facility in Whitechapel in London. The trial will begin in early autumn, with initial data expected by the end of the year.
"We are proud to be conducting this Phase I study for Codagenix, a leader in their field, as it will help bring a promising vaccine candidate to the public to help combat the Covid-19 pandemic as quickly as possible," said Cathal Friel, executive chairman of Open Orphan. "Hvivo, with its unique quarantine facility, is one of the few organisations in the world that has now publicly stated that it is working on testing Covid-19 vaccines for efficacy using human challenge model clinical trials."
Open Orphan is the result of Mr Friel reversing his pharma services business of the same name into Dublin-listed drug clinical trials manager Venn Life Sciences last year. It later acquired London-based Hvivo.
"Based on our animal data we expect this vaccine to be effective with a single dose, but will also evaluate a repeat dose to assess potential for boosting and as a model for protection from wildtype challenge," said Sybil Tasker, chief medical officer of Codagenix. "We plan to move quickly from this initial demonstration of safety and immunogenicity in a controlled inpatient setting to larger Phase 2/3 programme in conjunction with our partners at Serum Institute of India who are currently scaling up manufacturing to support rapid acceleration of our joint development programme."