Covid: Medicago-Gsk plant-based vaccine phase 3 test is underway

Rome, March 16 (beraking latest news Salute) – Canadian biopharmaceutical company Medicago and British GlaxoSmithKline (Gsk) announce the start of phase 3 clinical trials on Medicago’s plant-based Covid vaccine candidate, in combination with adjuvant pandemic of Gsk. Medicago has received approval from Canadian and US regulatory authorities to proceed with the enrollment of healthy adults in the phase 3 part of the study based on positive intermediate phase 2 results.

“We are delighted to take the significant step of launching Phase 3 clinical trials at sites around the world,” said Takashi Nagao, Cep and president of Medicago. “This takes us one step closer to providing a major new Covid-19 vaccine and contributing to the global fight against the pandemic together with our partner GSK.” “This advancement towards late stage clinical trials – comments Thomas Breuer, Chief Medical Officer, Gsk Vaccines – further strengthens our confidence in the potential of the adjuvanted vaccine candidate to make a difference in the ongoing fight against Covid-19. We look forward to it. to share the results during the year “.

The study – the note details – will enroll up to 30,000 subjects initially composed of healthy adults (aged 18 to 65), followed by elderly adults (aged 65 and over) and adults with comorbidities. The trial will take place in 10 countries awaiting regulatory approval, starting with Canada and the United States, and will enroll males and females from different ethnic and racial populations.

Medicago’s plant-derived vaccine candidate – reads a note – uses Coronavirus-Like-Particle (CoVLP) technology with the vaccine composed of recombinant glycoprotein (S) expressed as virus-like particles (Vlp) co-administered with the pandemic adjuvant of Gsk. Two 3.75 μg doses of CoVLP are given 21 days apart.

The vaccine candidate, in combination with the pandemic adjuvant, was awarded Fast Track designation by the US Food and Drug Administration (Fda) on February 17, 2021. The Fast Track designation allows the US regulatory agency to accelerate the development and review of new drugs and vaccines designed to treat or prevent serious conditions and address an unmet medical need.

“The FDA’s decision to grant Fast Track designation for Medicago’s vaccine candidate will help us accelerate our efforts to bring the first plant-derived COVID-19 vaccine to market, subject to regulatory approval,” said Carolyn Finkle, Chief Medicago operating officer. “We are grateful to the FDA and look forward to continuing to work with them as we proceed with our clinical trials, the planned emergency use authorization application and the eventual vaccine licensing application process.”