Humanigen Inc (NASDAQ: HGEN) has announced a peer-reviewed publication of a sub-analysis of Phase 3 LIVE-AIR study of lenzilumab in Thorax. Thorax is the leading respiratory medicine journal and the British Thoracic Society’s official journal.
CRP levels linked to response to immunomodulatory therapies
The publication describes the CRP’s role in the identification of patients that will derive the substantial benefit of lenzilumab. Study subjects in the LIVE-AIR trial with baseline CRP<10 mg/L that received lenzilumab showed a 62% reduction in the relative risk of invasive mechanical ventilation and fatality relative to placebo.
Chief Scientific Officer Dale Chapelle said, “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. These data demonstrate the importance of selecting the right treatment for the right patient at the right time which can be guided by the widely available biomarker CRP.”
According to Chapelle, the data is important since it shows the utility of early neutralization of GM-CSF, which is an upstream cytokine tome cascade driver that can prevent IL-6, IL-1, and systemic inflammation markers production, including CRP, leading to better outcomes in patients.
Lenzilumab increased SWOV chance compared to placebo
In hospitalized COVID-19 individuals who were hypoxic but not mechanically ventilated, lenzilumab showed improvement in clinical outcomes. In the LIVE-AIR research, participants with a CRP level under 150 mg/L showed the most effect. According to this sub-analysis, lenzilumab increased the chance of SWOV relative to placebo, showed decreased odds and a 62 percent decrease in the risk level of patients receiving lenzilumab advancing to mechanical ventilation or dying, and increased time to healing. Patients receiving lenzilumab also had more ventilator-free days, lesser ICU days, and better recovery time.
CEO and Chairman Dr. Cameron Durrant commented, “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 the results of the NIH’s ACTIV-5/BET-B study of lenzilumab, which is designed to confirm this approach.”