- Lenzilumab treatment in Black and African-American patients in
the positive LIVE-AIR Phase 3 trial, having a CRP<150 mg/L,
resulted in a nearly 9-fold increase in survival without
ventilation
- CDC data shows Black and African-American persons are at an
almost 3-fold greater risk of hospitalization and 2-fold greater
risk of death from COVID-19 infection1
- Black American vaccination rates are lowest nationally,
resulting in higher risk of infection, hospitalization, and
death2
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage
biopharmaceutical company focused on preventing and treating an
immune hyper-response called ‘cytokine storm’, announced analysis
of results from its Phase 3 LIVE-AIR study of lenzilumab in
hospitalized patients with COVID-19 suggesting Black and
African-American patients having a CRP<150 mg/L may be the
highest responders to treatment, with a nearly 9-fold increase in
likelihood of survival without ventilation (SWOV) [n=51,
p-value=0.0412]. In the overall population with CRP<150 mg/L,
LIVE-AIR Phase 3 results show patients treated with lenzilumab
demonstrated a 2.5-fold increased likelihood of SWOV [mITT, n=351,
p-value=0.0009].
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“Humanigen believes this analysis is an important finding
because Black and African-American patients are hyper-vulnerable to
COVID-19,” said Cameron Durrant, MD, Chief Executive Officer,
Humanigen. “In light of the rapid ongoing spread of the Delta
variant, data suggesting that Black and African-American patients,
who are hyper-vulnerable to COVID-19, and may be hyper-responsive
to lenzilumab is important in the broader context of the potential
benefits that may result if the FDA were to grant emergency use
authorization.”
The Centers for Disease Control and Prevention (CDC) has found
that race and ethnicity are risk markers for other conditions that
affect health, including socioeconomic status, access to health
care, and exposure to SARS-CoV-2 related to occupation, such as
frontline, essential, and critical infrastructure workers.1 The
American Heart Association’s COVID-19 Cardiovascular Disease
Registry found that Black patients had the highest prevalence of
obesity, hypertension, and diabetes, all of which are medical
conditions the CDC identifies as making adults of any age more
likely to get severely ill from COVID-19.3,4
“In the interest of public health and safety, it is our priority
to share data with stakeholders to improve our understanding of the
disease and potential treatments,” said Adrian Kilcoyne, MD, Chief
Medical Officer, Humanigen. “While there may be some limitations to
subset analyses, we believe the ongoing public health crisis caused
by SARS-CoV-2 warrants consideration of these important data by
regulatory authorities.”
Humanigen intends to submit data from this analysis for
publication in a peer-reviewed journal and present the findings at
a medical meeting. These new data from the LIVE-AIR study will also
be shared with regulatory authorities in the US, UK, European
Union, and other geographies.
About the LIVE-AIR, Phase 3 Study of Lenzilumab
LIVE-AIR Phase 3 study met its primary endpoint of survival
without ventilation demonstrating a 1.54-fold improvement overall
and trended to a 2.68-fold improvement in Black and
African-American patients. This study was a randomized,
double-blind, placebo-controlled, multi-center Phase 3 trial for
the treatment and prevention of serious and potentially fatal
outcomes in patients hospitalized with COVID-19 pneumonia. The
primary objective was to assess whether lenzilumab, in addition to
other treatments, which included dexamethasone (or other steroids)
and/or remdesivir, could alleviate the immune-mediated ‘cytokine
storm’ and improve survival without ventilation, or ‘SWOV’
(sometimes referred to as ‘ventilator-free survival’). SWOV is a
composite endpoint of time to death and time to invasive mechanical
ventilation (IMV), which is a robust measure that is less prone to
favor a treatment with discordant effects on survival or days free
of ventilation.5
The LIVE-AIR study enrolled 520 patients in 29 sites in the US
and Brazil who were at least 18 years of age; experienced blood
oxygen saturation (SpO2) of less than or equal to 94%; or required
low-flow supplemental oxygen, or high-flow oxygen support, or
non-invasive positive pressure ventilation; and were hospitalized
but did not require IMV. Following enrollment, subjects were
randomized to receive three infusions of either lenzilumab or
placebo, each infusion separated by eight hours over a 24-hour
period. The primary endpoint was the difference between lenzilumab
treatment and placebo treatment in SWOV through day 28 following
treatment. Key secondary endpoints, also measured through day 28,
included ventilator-free days, duration of ICU stay, incidence of
IMV, extracorporeal membrane oxygenation (ECMO), and/or death, time
to death, all-cause mortality, and time to recovery. Results of the
trial have been submitted for publication in a peer-reviewed
journal.
About Humanigen, Inc.
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage
biopharmaceutical company focused on preventing and treating an
immune hyper-response called ‘cytokine storm’. Lenzilumab is a
first-in class antibody that binds to and neutralizes
granulocyte-macrophage colony-stimulating factor (GM-CSF). Results
from preclinical models indicate GM-CSF is an upstream regulator of
many inflammatory cytokines and chemokines involved in the cytokine
storm. Early in the COVID-19 pandemic, investigation showed high
levels of GM-CSF secreting T cells were associated with disease
severity and intensive care unit admission. Humanigen’s Phase 3
LIVE-AIR study suggests early intervention with lenzilumab may
prevent consequences of a full-blown cytokine storm in hospitalized
patients with COVID-19. Humanigen is developing lenzilumab as a
treatment for cytokine storm associated with CD19-targeted CAR-T
cell therapies and exploring the effectiveness of lenzilumab in
other inflammatory conditions such as acute Graft versus Host
Disease (aGvHD) in patients undergoing allogeneic hematopoietic
stem cell transplantation (HSCT), eosinophilic asthma, and
rheumatoid arthritis. Humanigen is also developing a portfolio of
clinical and pre-clinical therapies for the treatment of
inflammation and immuno-oncology. For more information, visit
www.humanigen.com and follow Humanigen on LinkedIn, Twitter, and
Facebook.
Humanigen 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 effectiveness of lenzilumab in
Black and African-American patients; the review of our submission
for emergency use authorization by the FDA; and our other plans to
explore the effectiveness of lenzilumab and other candidates in our
development portfolio as therapies for other inflammation and
immune-oncology indications.
Forward-looking statements are subject to a number of risks and
uncertainties including, but not limited to, the risks inherent in
our lack of profitability and need for additional capital to grow
our business; our dependence on partners to further the development
of our product candidates; the uncertainties inherent in the
development, attainment of the requisite regulatory authorizations
and approvals and launch of any new pharmaceutical product; the
outcome of pending or future litigation; and the various risks and
uncertainties described in the "Risk Factors" sections of our
latest annual and quarterly reports and other filings with the
SEC.
All forward-looking statements are expressly qualified in their
entirety by this cautionary notice. You should not rely upon any
forward-looking statements as predictions of future events. The
Company undertakes no obligation to revise or update any
forward-looking statements made in this filing to reflect events or
circumstances after the date hereof or to reflect new information
or the occurrence of unanticipated events, except as required by
law.
Sources:
- Centers for Disease Control and Prevention. (2021, July 16).
Risk for Covid-19 infection, hospitalization, and death by
race/ethnicity. Centers for Disease Control and Prevention.
https://www.cdc.gov/coronavirus/2019-ncov/covid-data/investigations-discovery/hospitalization-death-by-race-ethnicity.html#print.
- Ndugga, N., Hill, L., Artiga, S., & Parker, N. (2021, July
21). Latest Data On COVID-19 Vaccinations by Race/Ethnicity.
Coronavirus (COVID-19).
https://www.kff.org/coronavirus-covid-19/issue-brief/latest-data-on-covid-19-vaccinations-race-ethnicity/.
- Rodriguez, F., Solomon, N., de Lemos, J. A., et al. (2020).
Racial and Ethnic Differences in Presentation and Outcomes for
Patients Hospitalized with COVID-19: Findings from the American
Heart Association’s COVID-19 Cardiovascular Disease Registry.
Circulation, 143(24), 2332–2342.
https://doi.org/10.1161/circulationaha.120.052278
- Centers for Disease Control and Prevention. (2021, May 13).
Certain medical conditions and risk for severe covid-19 illness.
Centers for Disease Control and Prevention.
https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html.
- Novack V., Beitler J., Yitshak-Sade M., et al. (2020). Alive
and Ventilator-Free: A Hierarchical, Composite Outcome for Clinical
Trials in the Acute Respiratory Distress Syndrome. Critical Care
Medicine, 48(2), 158–166.
https://doi.org/10.1097/ccm.0000000000004104
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210804005396/en/
Humanigen Media Grace Catlett RXMD gcatlett@rxmedyn.com
516-318-8563
Humanigen Investor Relations Ken Trbovich Humanigen
trbo@humanigen.com 650-410-3206
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