Junshi Biosciences completes enrollment for Phase I COVID-19 study
Category: #healthcare  By Akshay Kedari  Date: 2020-07-13
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Junshi Biosciences completes enrollment for Phase I COVID-19 study

 

  • JS016 is apparently unique to the SARS-CoV-2 surface spike protein receptor-binding domain.
     
  • JS016 can block virus binding to the ACE2 surface cell receptor in an effective manner.

Junshi Biosciences, the Shanghai-based innovation-driven biopharmaceutical company, has reportedly announced the completion of the study subjects enrollment in Phase I trial of its SARS-CoV-2 neutralizing antibody named ‘JS016’. Antibody JS016 is the first coronavirus neutralizing antibody to enter clinical trials in China, followed by the clinical trials in the US in the second quarter.

Prof. Zhang Wenhong and Prof. Zhang Jing from Huashan Hospital Affiliated to Fudan University led the study as a double-blind, randomized, placebo-controlled Phase 1 clinical trial. The primary goal of a clinical trial was to evaluate the tolerability and safety of single-dose JS016 IV (Intravenous Injection) in forty healthy people, including both male and female.

The study registered its first patient on 7th June, completing dosing in all 40 subjects in four dosing groups. As of 12th July, no dose-limiting event has been observed. Antibody JS106 is the first neutralizing agent to enter clinical trials in healthy subjects in the world. 

For further study, Junshi Biosciences aims to initiate Phase Ib trials in non-severe patients followed by Phase II & Phase III in severe and critical patients. At the same time, the firm will also examine the prophylactic potential of JS016 in a high-risk population.

For the record, JS016 is unique to the SARS-CoV-2 surface spike protein receptor-binding domain and can block virus binding to the ACE2 surface cell receptor in an effective manner. 

Caused by the SARS-CoV-2, coronavirus is an acute respiratory infectious disease, which has brought the world to its knees. It has infected more than 12 million people, taking the lives of over half a million people worldwide. As of now, there is no approved vaccine or drugs that work against COVID-19.

Source Credit - https://www.globenewswire.com/news-release/2020/07/13/2060944/0/en/Junshi-Biosciences-Announces-Completion-of-Enrollment-in-Phase-I-Trial-of-SARS-CoV-2-Neutralizing-Antibody-JS016-in-China.html

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Akshay Kedari    

Akshay Kedari

Akshay holds a Bachelor’s degree in computer engineering. Despite having a penchant for software development and the like, Akshay took to writing as a career owing to his passion for the field. Presently, Akshay writes articles for itresearchbrief.com and a few oth...

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