Humanigen Announces Peer-Reviewed Publication in Thorax Supporting Early Treatment of Hospitalized COVID-19 Patients with Lenzilumab Guided by C-Reactive Protein
Humanigen, Inc. (HGEN) announced significant findings from the Phase 3 LIVE-AIR study of lenzilumab, highlighting its effectiveness in treating COVID-19 patients with elevated C-reactive protein (CRP) levels. Patients with baseline CRP <150 mg/L showed a 62% reduction in the risk of invasive mechanical ventilation or death when treated with lenzilumab compared to placebo. The likelihood of surviving without mechanical ventilation was 90% for those on lenzilumab, versus 79% for those receiving placebo. These results may support future Emergency Use Authorization from the FDA for lenzilumab.
- Lenzilumab showed a 62% reduction in the risk of progression to invasive mechanical ventilation or death (OR=0.38; p=0.0053).
- 90% of LIVE-AIR patients treated with lenzilumab plus standard care survived without mechanical ventilation compared to 79% with placebo (HR 2.54, p=0.0009).
- Increased ventilator-free days and fewer ICU days in lenzilumab-treated patients.
- None.
- A sub-analysis of the Phase 3 LIVE-AIR study of lenzilumab showed a strong correlation between C-reactive protein (CRP) and outcomes with lenzilumab treatment with the greatest clinical benefit experienced by patients with baseline CRP<150 mg/L
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In these patients, likelihood of survival without mechanical ventilation (SWOV) was achieved in
90% of LIVE-AIR patients treated with lenzilumab plus standard of care compared to79% treated with placebo plus standard of care, which was highly statistically significant (HR 2.54, p=0.0009) -
Lenzilumab-treated patients had a
62% relative reduction in the risk of progression to invasive mechanical ventilation or death (OR=0.38; p=0.0053)
“A growing body of scientific evidence links CRP levels and response to certain immunomodulatory therapies, suggesting an important role of CRP as a biomarker to guide treatment of COVID-19,” said
Lenzilumab improved clinical outcomes in hospitalized non-mechanically ventilated hypoxic COVID-19 patients.2 The greatest benefit was observed in those with a CRP level below 150 mg/L in the LIVE-AIR study. In this sub-analysis, lenzilumab improved the likelihood of SWOV compared with placebo (HR: 2.54; p=0.0009), demonstrated reduced odds (OR 0.38; p=0.0053) and a
“We believe data from our LIVE-AIR study provides a compelling argument for utilizing CRP as a biomarker to identify hospitalized patients for whom lenzilumab may provide the greatest benefit and we look forward to results of the NIH’s ACTIV-5/BET-B study of lenzilumab, which is designed to confirm this approach,” stated Dr.
Lenzilumab is an investigational product and is not approved or authorized in any country.
About Lenzilumab
Lenzilumab is a proprietary Humaneered® first-in-class monoclonal antibody that has been proven to neutralize GM-CSF, a cytokine of critical importance in the hyperinflammatory cascade, sometimes referred to as cytokine release syndrome, or cytokine storm, associated with COVID-19 and other indications. Lenzilumab binds to and neutralizes GM-CSF, potentially improving outcomes for patients hospitalized with COVID-19.
In CAR-T, lenzilumab successfully achieved the pre-specified primary endpoint at the recommended dose in a Phase 1b study with Yescarta® in which the overall response rate was
A study of lenzilumab is also underway for patients with chronic myelomonocytic leukemia (CMML) exhibiting RAS pathway mutations. This study builds on evidence from a Phase 1 study, conducted by
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Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment, and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward- looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding the potential clinical benefits of lenzilumab, statements pertaining to the sufficiency of results from ACTIV-5/BET-B to support an amended EUA submission; statements regarding the SHIELD, aGvHD, and CMML studies, and other statements regarding improving the safety and efficacy of CAR-T and our plans relating to lenzilumab.
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References
- Temesgen, Z. et al. (2022). C-reactive protein, a biomarker for early lenzilumab treatment of COVID-19, improves efficacy: a sub-analysis of the randomized phase 3 ‘LIVE-AIR’ trial. Thorax. http://dx.doi.org/10.1136/thoraxjnl-2022-218744
- Temesgen, Z. et al. (2021). Lenzilumab in hospitalised patients with COVID-19 pneumonia (LIVE-AIR): a phase 3, randomised, placebo-controlled trial. The Lancet Respiratory Medicine. https://doi.org/10.1016/S2213-2600(21)00494-X
Humaneered® is a trademark of
Yescarta® and Tecartus® are trademarks of Gilead Sciences, Inc., or its related companies.
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