Shionogi has commenced a Phase III clinical trial analysing additional doses of its monovalent Covid-19 vaccine against the XBB1.5 strain of the SARS-CoV-2 virus, S-268023.
The observer-blind, randomised, double-blind, active-controlled trial will enrol 600 adult participants in Japan to analyse the safety, efficacy and immunogenicity of an intramuscular booster dose of the vaccine versus the COMIRNATY vaccine.
Male and female subjects aged 20 years or above and who have already received two or more doses of an approved Covid-19 vaccine will be part of the trial.
To be eligible for the trial, subjects should have completed 90 days or more following receipt of initial vaccination or booster dose with an approved Covid-19 vaccine COMIRNATY RTU Spikevax Omicron XBB.1.5 targeting vaccine.
Furthermore, people without a Covid-19 infection history, or those with a history of SARS-CoV-2 have not been infected since March this year.
A manufacturing and sales approval application is underway in Japan for S-268023. On receipt of the approval, the company plans to establish itself as a platform to produce the first recombinant protein vaccine locally.
This move will aid in manufacturing vaccines in the country itself in the future, Shionogi noted.
The company enrolled the first Japanese subject in a Phase III trial of an oral antiviral, ensitrelvir, for Covid-19 in June this year.
Dubbed SCORPIO-PEP, the global, placebo-controlled, double-blind, randomised trial is designed to enrol nearly 2,200 subjects in South America, Europe, Asia, Africa and North America.
In another development, Shionogi has signed a distribution deal with Swedish Orphan Biovitrum (Sobi) for Fetcroja (cefiderocol) in the Czech Republic, Bulgaria, Hungary, Poland, Croatia, Slovakia, Slovenia, Romania, Estonia, Cyprus, Latvia Greece, and Lithuania.
Fetcroja is intended for use in adults with infections caused by aerobic Gram-negative organisms in people with limited therapy options.
Sobi will use its commercial expertise and supply chain networks to endorse and market cefiderocol in these territories while Shionogi will serve as the marketing authorisation holder of Fetcroja.
