China-based vaccines firm Sinovac Biotech Ltd (NASDAQ: SVA) has announced the completion of a Phase I trial and the immediate initiation of a Phase II study for its broad-spectrum COVID-19 neutralizing antibody, SA55. The molecule, which was first approved to enter clinical trials in China on May 24 this year, is intended to treat COVID-19 infections.
Phase II Study Design and Objectives
Following the demonstration of safety in the Phase I study, the Phase II study, initiated in Shanghai, will recruit 150 adult subjects with mild to moderate COVID-19 infection from nearly 20 hospitals across China. Patients will be administered either the SA55 injection or a placebo to evaluate the molecule’s efficacy in reducing SARS-CoV-2 virus loads and alleviating clinical symptoms, along with a comprehensive safety assessment. Preliminary results are expected by the end of the year.
Development and Potential Applications of SA55
SA55 was developed by a research team led by Dr. Xiaoliang Xie, academician of the Chinese Academy of Sciences, and Dr. Yunlong Cao, researcher at Peking University’s Biomedical Pioneering Innovation Center. The fully humanized antibody was screened from the blood of recovered SARS patients who had received three doses of a COVID-19 vaccine and was then recombinantly expressed. SA55 is anticipated to serve both as a treatment and a preventive measure for COVID-19.
Sinovac’s Track Record in COVID-19 Response
Sinovac, which was previously responsible for the COVID-19 vaccine CoronaVac, has a proven track record in the development of vaccines and therapeutics for COVID-19. CoronaVac has gained approvals in over 60 countries and regions worldwide, highlighting Sinovac’s commitment to combating the pandemic and contributing to global health.-Fineline Info & Tech
