Medicago, GSK Begin Phase 3 Trial Of Plant-derived COVID-19 Vaccine Candidate - Quick Facts

Canadian biopharmaceutical company Medicago, Inc. (MDG.TO) and GlaxoSmithKline (GSK) announced Tuesday the start of Phase 3 clinical testing of Medicago's plant-derived COVID-19 vaccine candidate in combination with GSK's pandemic adjuvant, as part of the ongoing Phase 2/3 study.

Medicago received approval from Canadian and US regulatory authorities to proceed with enrollment of healthy adults in the Phase 3 portion of the trial based on positive interim Phase 2 results.

The Phase 3 portion of the study is an event-driven, randomized, observer-blinded, placebo-controlled, two-way cross-over design that will evaluate the efficacy and safety of the adjuvanted CoVLP formulation, compared to placebo.

The trial will enroll up to 30,000 volunteers worldwide and will take place in 10 countries pending regulatory approvals, starting with Canada and the United States,

In parallel, Medicago has also initiated a feasibility study of a vaccine candidate to address the emerging COVID-19 variants.

Medicago's plant-derived vaccine candidate against COVID-19 uses Coronavirus-Like-Particle (CoVLP) technology with the vaccine composed of recombinant spike (S) glycoprotein expressed as virus-like-particles (VLPs) co-administered with GSK's pandemic adjuvant. Two doses of 3.75 micrograms of CoVLP are administered 21 days apart.

The plant-derived vaccine candidate, in combination with the pandemic adjuvant, was granted Fast Track designation by the US Food and Drug Administration (FDA) on February 17, 2021.

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