Quebec, October 1, 2021 – Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) announced today that Phase 1/2 clinical trials will begin in Japan on October 2, 2021, for Medicago’s plant-derived virus-like particle (VLP) COVID-19 vaccine candidate in combination with GSK’s pandemic adjuvant. This study will be conducted by Mitsubishi Tanabe Pharma Corporation, the parent company of Medicago.
This Japanese study, in combination with final data from the global Phase 2/3 study of the vaccine candidate, will be used to support an application for regulatory approval in Japan by March of 2022.
Medicago’s COVID-19 vaccine candidate has now completed enrollment of its Phase 2/3 clinical trials with approximately 24,000 subjects enrolled in Canada, the US, the UK, Brazil, Argentina and Mexico. Results are now undergoing analysis to determine safety and efficacy.
For details of this study, please visit Japan Regulatory of Clinical Trials website (https://jrct.niph.go.jp/) and enter jRCT number (jRCT2051210093) from search page to view.
About the study
- The study will enroll 145 Japanese male and female subjects aged 20 years or older.
- It will be a randomized, placebo-controlled study. Subjects will be assigned to three groups: normal dose group, lower dose group and placebo group.
- Subjects will receive two doses at 21 days apart.
- The data will be evaluated for safety and immunogenicity
Medicago is on a mission to improve global public health using the power of plants. Founded in 1999 with the belief that innovative approaches and rigorous research would bring new solutions in healthcare, Medicago is a pioneer in plant-derived therapeutics. Proudly rooted in Quebec, with manufacturing capacity in both Canada and the US. Medicago has a passionate and curious team of over 500 scientific experts and employees dedicated to using its technology to provide rapid responses to emerging global health challenges, and to advancing therapeutics against life-threatening diseases worldwide.
Medicago is an affiliated company of Mitsubishi Tanabe Pharma Corporation.
For more information: www.medicago.com
About GSK and its commitment to tackling COVID-19
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us. GSK is collaborating with companies and research groups across the world working on promising COVID-19 vaccine candidates through the use of our innovative vaccine adjuvant technology. The use of an adjuvant is of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to protecting more people. GSK does not expect to profit from COVID-19 vaccines during the pandemic phase and will invest any short-term profit in coronavirus related research and long-term pandemic preparedness, either through GSK internal investments or with external partners.