Pharmaceutical giant GlaxoSmithKline said on Tuesday that it has started Phase 3 clinical testing of Medicago’s plant-derived Covid-19 vaccine candidate in combination with its own pandemic adjuvant.
GlaxoSmithKline said Medicago had already received approval from Canadian and US regulatory authorities to proceed with the enrolment of healthy adults in the Phase 3 portion of the trial based on positive interim Phase 2 results, while the vaccine candidate, in combination with the pandemic adjuvant, was granted Fast Track designation by the Food and Drug Administration on 17 February.
The FTSE 100-listed firm said the Phase 3 portion of the study was an event-driven, randomised, observer-blinded, placebo-controlled, two-way cross-over design that will evaluate the efficacy and safety of the adjuvanted CoVLP formulation.
The study will enrol up to 30,000 subjects, initially composed of healthy adults and followed by elderly adults and adults with comorbidities, and will take place in ten countries, pending regulatory approvals, starting with Canada and the United States.
Chief medical officer Thomas Breuer said: “This advance to late-stage clinical testing further reinforces our confidence in the adjuvanted vaccine candidate’s potential to make a difference in the continued fight against Covid-19. We look forward to sharing results later this year.”
As of 1320 GMT, GSK shares were up 0.84% at 1,276.60p.
