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Summary
- Canadian biopharmaceutical firm Medicago Inc announced on Tuesday that its plant-derived COVID-19 vaccine candidate has been ushered into Phase 3 clinical trials.
- Medicago said that its shot will be tested in combination with British company GlaxoSmithKline’s COVID-19 adjuvant as part of the ongoing Phase 2/3 study.
- The Canadian and US regulatory authorities have reportedly approved the Quebec-based company’s application to enroll candidates in its Phase 3 trials based on positive interim results of its Phase 2 study.
Canadian biopharmaceutical firm Medicago Inc announced on Tuesday, March 16, that its plant-derived COVID-19 vaccine candidate has been ushered into Phase 3 clinical trials.
Medicago said that its shot will be tested in combination with British company GlaxoSmithKline’s (LON:GSK) COVID-19 adjuvant as part of the ongoing Phase 2/3 study.
Let’s find out more about Medicago’s late-stage trials.
Medicago COVID-19 Vaccine Candidates Phase 3 Trials – Key Insights
Medicago, a plant-based biotech researcher, became a privately held company in September 2013. Its shares, formerly listed under the ticker of ‘MDG’, were removed from the Toronto Stock Exchange in 2013 following its transition to the private sector.
The Canadian and US regulatory authorities have reportedly approved the Quebec-based company’s application to enroll candidates in its Phase 3 trials based on positive interim results of its Phase 2 study.
Medicago said that the Phase 3 portion of the trials, which will be randomized and observer-blinded, will review the efficacy and safety parameters of the adjuvanted CoVLP formulation is comparison to placebos.
©Kalkine Group 2020
The study will be conducted with up to 30,000 subjects in total, the initial stage of which will see healthy adults in the age group of 18 years to 65 years. Later on, the study will focus on elderly people above the age of 65 years and adults who live with comorbidities.
The biotech firm also said that the trial will be conducted in 10 countries following required regulatory approvals.
Medicago has also started working on a feasibility study for a vaccine candidate focused on the emerging mutant variants of the COVID-19 disease.
What Do We Know About Medicago’s Plant-Based COVID-19 Vaccine Candidate?
A vaccine is generally developed by using a non-infectious version of the target virus which, when administered, triggers the body into building an immune system to fight the real virus.
©Kalkine Group 2020
While such non-contagious particles are typically developed in labs using live viruses, Medicago came up with a way to use live plants as bioreactors to create the Coronavirus-like Particles (CoVLPs). It is said to have successfully produced a CoVLP to combat the COVID-19 virus, SARS-CoV-2, in early March last year.
Medicago's plant-based COVID-19 vaccine candidate, which comes with a booster from GlaxoSmithKline, is required to be administered in two doses 21 days apart.
The US Food and Drug Administration (FDA) greenlit Medicago’s vaccine candidate, in combination with GlaxoSmithKline’s pandemic adjuvant, for a Fast Track designation on February 17.
