Hyderabad: The interim results of clinical trial of I-Mab-discovered TJM2, to evaluate the therapeutic role of anti granulocyte-macrophage colony stimulating factor (GM-CSF) antibody in severe COVID-19 patients, suggest that it is potential enough to address the complications among the severe and critically-ill patients and ultimately save lives.
I-Mab, clinical-stage bio pharmaceutical company committed to the discovery, development and commercialization of novel biologics, followed a rigorous and robust clinical trial protocol, the first among similar anti-GM-CSF antibody studies globally, to ensure robustness of the study conclusion and data integrity.
The announcement was made by the data monitoring committee (DMC), who reviewed the part 1 of the study to assess patient's safety and overall conduct of the study.
Following which, after comprehensive review and analysis, the DMC concluded that I-Mab can commence the Part 2 of the study as planned, indicating TJM2 is safe and well-tolerated in the severe COVID-19 patients.
"Part 2 of the study with a similar design to Part 1 will target the same patient population and is expected to be initiated shortly. It will evaluate the efficacy, safety and cytokine levels following a single dose of 6mg/kg TJM2or placebo in 120 patients with severe COVID-19," informed the committee.
Additionally, the DMC also endorsed protocol changes, including broadening the inclusion criteria and dosing all patients at 6 mg/kg of TJM2 or placebo.
Dr. Jingwu Zang, M.D., Ph.D., Founder and Honorary Chairman and Director of I-Mab said, "As an innovative global biotech company, I-Mab has a responsibility to help address the urgent global health crisis. Since the outbreak took place, we sprang into action to prioritize TJM2 in response to the urgent medical needs. It is clear that the rationale and expectation of our study is further supported by the preliminary and encouraging evidence from other pilot studies with GM-CSF antibody class for this clinical indication."
According to the WHO, as of May 26, 2020, there were 5,404,512 confirmed cases and 343,514 deaths of COVID-19 globally. Severe and critically ill patients account for approximately 20% of all diagnosed patients.
About TJM2
TJM2 is an internally discovered neutralizing antibody against human GM-CSF, an important cytokine that plays a critical role in chronic inflammation and destruction in autoimmune diseases.
It is expected to be the first antibody of its class to enter clinical trials in China in 2020.
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