Humanigen Inc (HGENQ)

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Humanigen Announces Abstracts Accepted for the British Thoracic Society Winter Meeting 2021

https://ir.humanigen.com/English/news/news-details/2021/Humanigen-Announces-Abstracts-Accepted-for-the-British-Thoracic-Society-Winter-Meeting-2021/default.aspx

***Abstract #S48 describes top-line results from the Humanigen Phase 3 LIVE-AIR study in hospitalized COVID-19 patients, which reveal a 54% relative improvement in the likelihood of survival without invasive mechanical ventilation (“SWOV”) in lenzilumab-treated patients compared to those treated with standard of care plus placebo

Abstract #S49 describes an exploratory analysis from LIVE-AIR demonstrating a 3-fold improvement in SWOV in hospitalized COVID-19 patients less than 85 years with baseline CRP<150 mg/L treated with lenzilumab compared to those treated with standard of care plus placebo

Abstract #S51 describes an analysis from the literature related to several in-hospital COVID-19 treatments, which shows the number of patients needed to be treated to prevent a single death in the subsequent 28-day period was 22.7 for lenzilumab, 26.3 for remdesivir, and 37.0 for baricitinib

BURLINGAME, Calif.--(BUSINESS WIRE)-- Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, today announced three abstracts pertaining to the potential use of lenzilumab in hospitalized COVID-19 patients will be presented at the British Thoracic Society Winter 2021 Meeting taking place Nov. 24-26, 2021. The society counts more than 4,000 members comprised of doctors, nurses, respiratory physiotherapists, scientists, and other professionals with a respiratory interest.

“We are pleased to have the opportunity to share the results of our Phase 3 study of lenzilumab in hospitalized COVID-19 patients with our medical and scientific colleagues in the United Kingdom,” said Cameron Durrant, MD, Chairman & CEO, Humanigen. “We believe the analysis of our LIVE-AIR data using baseline C-reactive protein (CRP) levels is important because it identifies a subset of patients, approximately 75% of the study population, for which lenzilumab treatment appears to show the greatest benefit. This is particularly relevant in the United Kingdom, where the government funded the formation of the International Severe Acute Respiratory Infection Consortium (ISARIC), a UK-wide consortium of doctors and scientists, that developed the 4C Mortality Score, which utilizes CRP levels as the only biomarker marker used to calculate the score. By focusing on patients most likely to benefit from treatment with lenzilumab, analysis shows the number needed to be treated to potentially prevent a death over a subsequent 28-day period may be reduced from 22.7 to 13.9.”

Lenzilumab is not authorized, or approved, in any country.

Abstract #S48
Lenzilumab Efficacy and Safety in Newly Hospitalized Covid-19 Subjects: Results from the LIVE-AIR Phase 3 Randomized Double-Blind Placebo-Controlled Trial

Summary: The abstract describes top-line results from Humanigen’s LIVE-AIR Phase 3 study, which reveal a 54% improvement (HR: 1.54; p=0.0403) in SWOV in lenzilumab-treated patients hospitalized with COVID-19 compared to those treated with standard of care plus placebo. The study also demonstrated significant improvement in SWOV for the predefined subgroup of subjects who received both corticosteroids and remdesivir (HR: 1.92; nominal p=0.0067). The incidence of treatment-emergent serious adverse events was similar across treatment groups. Treatment with lenzilumab resulted in no serious infusion-related reactions, no increase in the incidence of secondary infections and no attributable serious adverse events, including, hematologic or liver enzyme abnormalities. In addition, no cases of pulmonary alveolar proteinosis were reported.

Abstract #S49
C-Reactive Protein as a Biomarker for Improved Efficacy of Lenzilumab in Covid-19 Patients: Results from the LIVE-AIR Trial

Summary: The abstract describes an exploratory analysis of LIVE-AIR data, from the Phase 3 study of lenzilumab in patients hospitalized with COVID-19, based upon an assessment of baseline CRP measurements, a biomarker that is commonly used to assess the body’s inflammatory response. The analysis shows those patients in the LIVE-AIR clinical trial with baseline CRP<150 mg/L and age <85 who were treated with lenzilumab benefited from a 3-fold improvement in SWOV (HR: 3.04; nominal p=0.0003) compared to those treated with standard of care plus placebo. The analysis led to the conclusion that inhibition of GM-CSF, an orchestrator of cytokine storm, by lenzilumab early in the hyperinflammatory response improves outcomes in COVID-19.

Abstract #S51
Evaluation of Treatment Approaches for Hospitalized COVID-19 Patients

Summary: The abstract describes an analysis from literature of several in-hospital COVID-19 treatments, which showed the number patients needed to be treated (NNT) to prevent a single death in a subsequent 28-day period were 22.7 for lenzilumab, 26.3 for remdesivir, and 37.0 for baricitinib. The NNT for lenzilumab improved with refinement of concomitant medications and patient phenotype. The NNT to prevent a single death in a subsequent 28-day period is reduced to 13.9 in patients age less than 85 years with a CRP<150 mg/L.

About ISARIC Coronavirus Clinical Characterisation Consortium (4C) Mortality Score

The UK government funded the formation of ISARIC 4C (Coronavirus Clinical Characterisation Consortium), a consortium of doctors and scientists across the UK that gathered and analyzed samples from COVID-19 patients.1 Using data from 57,824 patients, ISARIC developed the 4-C Mortality Score.2 This risk-stratification tool outperformed existing risk-stratification tools and has been extensively validated in independent studies in other countries across the world, including France, The Netherlands, Italy, Pakistan, Turkey, and Canada.3 Use of the assessment tool results in a 4C Mortality Score that can range from 0-21 with direct correlation between a higher score and higher mortality rate. For example, a score of 1 equates to a mortality rate of 0.3%, while a score of 10 equates to 22.9% mortality rate, and a score of 21 is associated with an 87.5% mortality rate.4 CRP levels are one of the eight variables and the only biomarker utilized in this scoring system to arrive at the 4C Mortality Score and increasing CRP levels lead to higher scores (e.g., CRP<50 mg/L = +0, CRP 50-99 mg/L = +1, CRP≥ 100 mg/L = +2)4.