- Lenzilumab improved the relative likelihood of survival without
need for invasive mechanical ventilation (IMV) by 54%, achieving
the primary endpoint of the Phase 3 study
- Clinical improvement was observed over and above other
treatments, including steroids and/or remdesivir
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 positive topline results
from its Phase 3 clinical trial evaluating the efficacy and safety
of lenzilumab in patients hospitalized with COVID-19. Trial results
showed that patients who received lenzilumab and other treatments,
including steroids and/or remdesivir, had a 54% greater relative
likelihood of survival without the need for IMV compared with
patients receiving placebo and other treatments. These results are
statistically significant.
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“The results from our Phase 3 clinical trial with lenzilumab
treatment were associated with better outcomes in hospitalized
hypoxic COVID-19 patients who had not yet progressed to the point
of requiring IMV,” said Cameron Durrant, MD, MBA, Chief Executive
Officer, Humanigen. “Additionally, the trial incorporated a diverse
population with various comorbidities, most commonly a body mass
index above 30, which is representative of a real-world, high-risk
population. Our next step is to submit an application for Emergency
Use Authorization (EUA) to the Food and Drug Administration (FDA)
as soon as possible. We are also sharing these results with US
governmental agencies and other authorities worldwide.”
“Mayo Clinic is pleased to have been part of the investigation
of lenzilumab from the earliest days of the development program in
COVID-19 and are excited by these data,” said Andrew Badley, MD,
Professor of Infectious Diseases, and Professor and Chair of the
Department of Molecular Medicine at Mayo Clinic. “If lenzilumab is
authorized for emergency use by FDA, and based on our clinical
trial experience to date, it may then be considered a part of our
treatment armamentarium for newly hospitalized patients with
COVID-19.”
Study results demonstrate that lenzilumab significantly improved
patient outcomes. The study achieved its primary endpoint of
ventilator-free survival measured through day 28 following
treatment (HR: 1.54; 95%CI: 1.03-2.33, p=0.0365). Ventilator-free
survival is a validated and reliable measure used in studies that
evaluate respiratory distress.1 The Kaplan-Meier estimate for IMV
and/or death was 15.6% (95%CI: 11.5-21.0) in the lenzilumab arm
versus 22.1% (95%CI: 17.4-27.9) in the placebo arm, representing a
54% improvement in the relative likelihood of survival without the
need for IMV. Although this study was not powered to demonstrate a
difference in mortality, a favorable trend in mortality was
observed: 9.6% (95%CI: 6.4-14.2) in the lenzilumab arm compared
with 13.9% (95%CI: 10.1-19.0) in the placebo arm (HR: 1.39; 95%CI:
0.82-2.39; p=0.2287). Approximately 88% of patients received
dexamethasone (or other steroids), 62% received remdesivir, and 57%
received both, balanced across both arms of the study. Serious
adverse events (SAEs) were balanced in both study arms and the SAE
profile was similar to that previously documented in prior
lenzilumab studies. In this study, lenzilumab appeared to be safe
and well-tolerated; no new SAEs were identified, and none were
attributed to lenzilumab.
“The data strongly suggest that lenzilumab improved outcomes for
hospitalized patients with COVID-19 pneumonia,” said Zelalem
Temesgen, MD, Professor of Medicine at Mayo Clinic and Principal
Investigator of the Phase 3 trial. “The dosing regimen used in this
study was specifically designed for hospitalized patients with
COVID-19 pneumonia as a potential foundational therapy. Lenzilumab
could make the difference between going on a ventilator, which
reduces one’s chance of survival, and leaving the hospital
alive.”
“It is impressive to see lenzilumab achieve this milestone. At
Emory University, a key center in the National Institutes of Health
(NIH) ACTIV-5 study, which is currently enrolling, we are hopeful
that lenzilumab will emerge as a valuable therapy for newly
hospitalized patients. We believe there may be future opportunities
to study lenzilumab in even larger trials, and further explore
lenzilumab’s impact on mortality rates,” added Vincent Marconi, MD,
Professor of Medicine at Emory University School of Medicine.
About the Lenzilumab Phase 3 Study
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 who were
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 release syndrome (CRS) and
improve ventilator-free survival. Ventilator-free survival is a
composite endpoint of time to death and time to IMV, which is a
robust measure that is less prone to favor a treatment with
discordant effects on survival or days free of ventilation.1 The
trial 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 (NIPPV); 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 with other
treatments. The primary endpoint was the difference between
lenzilumab treatment and placebo treatment in ventilator-free
survival through 28 days following treatment. Key secondary
endpoints, also measured through 28 days, included ventilator-free
days, duration of ICU stay, incidence of invasive mechanical
ventilation, extracorporeal membrane oxygenation (ECMO), and/or
death, time to death, all-cause mortality, and time to recovery.
Results of the trial are planned to be submitted for potential
publication in a peer-reviewed journal.
About Humanigen, Inc.
Humanigen, Inc. is developing its portfolio of clinical and
pre-clinical therapies for the treatment of cancers and infectious
diseases via its novel, cutting-edge GM-CSF neutralization and
gene-knockout platforms. Humanigen’s immediate focus is to prevent
or minimize cytokine release syndrome that precedes severe lung
dysfunction in hospitalized and hypoxic patients with COVID-19
pneumonia. Humanigen is also working to create next-generation
combinatory gene-edited CAR-T therapies using strategies to improve
efficacy while employing GM-CSF gene knockout technologies to
control toxicity. In addition, Humanigen is developing its own
portfolio of proprietary first-in-class EphA3-CAR-T for various
solid cancers and EMR1-CAR-T for various eosinophilic disorders.
Humanigen is also exploring the effectiveness of its GM-CSF
neutralization technologies (either through the use of lenzilumab
as a neutralizing antibody or through GM-CSF gene knockout) in
combination with other CAR-T, bispecific or natural killer (NK)
T-cell-engaging immunotherapy treatments to break the
efficacy/toxicity linkage, including to prevent and/or treat Graft
versus Host Disease (GvHD) in patients undergoing allogeneic
hematopoietic stem cell transplantation (HSCT). Additionally,
Humanigen and Kite, a Gilead Company, are evaluating lenzilumab in
combination with Yescarta® (axicabtagene ciloleucel) in patients
with relapsed or refractory large B-cell lymphoma in a clinical
collaboration. 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 our potential request for and
receipt of an Emergency Use Authorization from FDA for lenzilumab
in COVID-19; and our other plans relating to lenzilumab as a result
of the release of the topline results.
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. We
undertake no obligation to revise or update any forward-looking
statements made in this presentation to reflect events or
circumstances after the date hereof, to reflect new information or
the occurrence of unanticipated events, to update the reasons why
actual results could differ materially from those anticipated in
the forward-looking statements, in each case, except as required by
law.
For media resources, including product images and fact sheet,
please click here.
___________________________
1 Novack V, Beitler JR, Yitshak-Sade M, Thompson BT, Schoenfeld
DA, Rubenfeld G, et al. Alive and Ventilator Free: A Hierarchical,
Composite Outcome for Clinical Trials in the Acute Respiratory
Distress Syndrome. Critical care medicine. 2020;48(2):158-66
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Humanigen Media Grace Catlett RXMD Gcatlett@rxmedyn.com
516-318-8563
Humanigen Investors Alan Lada Solebury Trout
ALada@SoleburyTrout.com 617-221-8006
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