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Multivariate analysis of LIVE-AIR Phase 3 data indicates that elevated baseline C-reactive protein (“CRP”) is the most predictive feature of progression to invasive mechanical ventilation (“IMV”) or death, and may be a guide Useful biomarker therapeutic intervention
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Compared with patients who received placebo, patients who received lenzilumab with a baseline CRP of <150 mg/L were more than 2.5 times more likely to survive without IMV (p<0.001)
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The results of the study show that hospitalized COVID-19 patients in the early stage of hyperimmune response have lower baseline CRP levels (CRP <150 mg/l) and obtain greater clinical benefits from lenzilumab treatment
Humanigen, Inc. (NASDAQ stock code:Hydrogen energy) (“Humanigen”), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of an immune overreaction called “cytokine storm” and its main drug candidate lenzilumab, announced a manuscript detailing the analysis of CRP levels The results from the LIVE-AIR Phase 3 study are available on medRxiv (https://www.medrxiv.org/content/10.1101/2021.12.30.21267140v1). The results indicate that for hospitalized COVID-19 patients with low baseline CRP levels, the greatest clinical benefit of lenzilumab treatment may be realized, which usually occurs in the early stages of disease progression.
Granulocyte-macrophage colony stimulating factor (GM-CSF) is the early upstream mediator and coordinator of the inflammatory immune response after SARS-CoV-2 infection, and is used to activate and expand inflammatory bone marrow cells. The increase in CRP is driven by the increase in downstream cytokines derived from bone marrow cells. High levels of CRP (>150 mg/L) may indicate that sufficient myeloid cell activation has occurred in a highly inflammatory immune response stage, making GM-CSF neutralization insufficient to prevent further disease progression.
This analysis and publication provide evidence that a biomarker-driven approach using baseline CRP levels to guide therapeutic intervention and patient selection may improve the prognosis of COVID-19 hospitalized patients.
“We are encouraged by these results,” said Dr. Dale Chappell, Chief Scientific Officer of Humanigen. “In the context of other GM-CSF targeted therapies that have failed to make progress in the development of COVID-19, these results confirm the importance of selecting patients and understanding the disease process when designing clinical trials. Importantly, ACTIV-5/ BET-B is a potential confirmatory phase 2/3 study that uses CRP <150 mg/L to define the main analysis population."
Dr. Cameron Durrant, Chief Executive Officer of Humanigen, added: “The PREACH-M study of chronic myelomonocytic leukemia conducted in 5 centers in Australia has begun to be administered to patients. The SHIELD study in CAR-T and RATiinG for acute grafts Research versus host disease (aGvHD) is planned to start recruitment in the United States and the United Kingdom in the first half of 2022. Other COVID studies to be completed or initiated in 2022 include the NIH-sponsored ACTIV-5/BET-B study in the United States and South Korea and C -SMART research…
The full story can be found on Benzinga.com
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