(Alliance News) -Â GlaxoSmithKline PLC and Canada's Medicago are starting a phase three trial for their Covid-19 vaccine candidate, GSK said on Tuesday.
Medicago has received approval from Canadian and US regulatory authorities to proceed with the enrolment of healthy adults in the phase three portion of the trial, based on positive interim phase two results. The phase two part of the trial is approaching completion, and results are expected to be made publicly available in April, the companies said.
Medicago's plant-derived Covid-19 vaccine candidate in combination with GSK's pandemic adjuvant was granted fast track designation from the US Food & Drug Administration in February, allowing the regulator to speed up development and review.
The phase three portion of the study is "an event-driven, randomized, observer-blinded, placebo-controlled, two-way cross-over design" that will look at the efficacy and safety of the adjuvanted CoVLP formulation compared to placebo. The study will enrol up to 30,000 people initially composed of healthy adults, followed by elderly adults and adults with co-morbidities.
Thomas Breuer, chief medical officer at GSK Vaccines, 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."
The trial will take place in 10 countries pending regulatory approvals, starting with Canada and the US.
"We are pleased to take the significant step of initiating the phase 3 clinical trial at sites around the world," said Takashi Nagao, chief executive & president of Medicago. "This brings us one step closer to delivering an important new Covid-19 vaccine and contributing to the global fight against the pandemic along with our partner GSK."
Shares in GSK were up 1.1% at 1,280.00 pence in London on Tuesday.
By Lucy Heming;Â lucyheming@alliancenews.com
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