Humanigen Receives Preliminary Topline Data From NIH/NIAID Study of Lenzilumab in ACTIV-5/BET-B
July 12 2022 - 8:30PM
Business Wire
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”) has been informed
of preliminary topline results from the National Institute of
Allergy and Infectious Diseases’ (NIAID) ACTIV-5/BET-B trial
evaluating lenzilumab plus remdesivir versus placebo plus
remdesivir in hospitalized COVID-19 patients. The trial did not
achieve statistical significance on the primary endpoint, which was
defined as the proportion of patients with baseline CRP<150 mg/L
and age<85 years, alive and without mechanical ventilation
through Day 29. The data also showed a non-significant trend toward
a reduction in mortality in the overall patient population [HR
0.72]. There were no new safety signals attributed to lenzilumab in
the ACTIV-5/BET-B study.
“We are grateful for the constructive collaboration with
NIH/NIAID; while the ACTIV-5/BET-B study showed signs of a clinical
effect, the benefit demonstrated was not able to confirm the
positive results we saw in our Phase 3 LIVE-AIR study,” said
Cameron Durrant, Chairman and Chief Executive Officer, Humanigen.
“In order to prove the therapeutic benefits of immunomodulators,
platform studies comprising thousands of patients have been
necessary. With the continued resurgence of COVID-19, further
exploration of variant agnostic treatments to improve outcomes in
hospitalized COVID-19 patients should be a priority.”
About ACTIV-5/BET-B The Accelerating COVID-19 Therapeutic
Interventions and Vaccines (ACTIV) is a National Institutes of
Health (NIH) directed public-private partnership to develop a
coordinated research strategy for prioritizing and speeding
development of the most promising treatments and vaccines. ACTIV is
led by a working group of senior scientists representing
government, industry, non-profit, philanthropic, and academic
organizations and is pursuing five fast-track focus areas most ripe
for opportunity, one of which is accelerating clinical testing of
the most promising vaccines and treatments. Within this focus area
ACTIV-5 (Big Effect Trial, BET) is a series of randomized,
double-blind, placebo-controlled trials using common assessments
and endpoints to evaluate whether certain therapies, approved or
investigational, show promise treating patients hospitalized with
COVID-19.1
About Humanigen Humanigen, Inc. (Nasdaq: HGEN)
(“Humanigen”) is 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. Humanigen is developing lenzilumab
as a treatment for cytokine storm associated with CD19-targeted
CAR-T cell therapies and is also exploring the effectiveness of
lenzilumab in other inflammatory conditions such as acute Graft
versus Host Disease in patients undergoing allogeneic hematopoietic
stem cell transplantation, eosinophilic asthma, and rheumatoid
arthritis. Lenzilumab is an investigational product and is not
approved or authorized in any country. For more information, visit
www.humanigen.com and follow Humanigen on LinkedIn, Twitter, and
Facebook.
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
intentions with respect to the development of lenzilumab.
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 press release to reflect events or
circumstances after the date hereof, to reflect new information or
the occurrence of unanticipated events, or 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.
References
- National Institutes of Health. (n.d.). "ACCELERATING COVID-19
THERAPEUTIC INTERVENTIONS AND VACCINES (ACTIV)."
https://www.nih.gov/research-training/medical-research-initiatives/activ.
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Humanigen Investor Relations Ken Trbovich Humanigen
trbo@humanigen.com 650-410-3206
Humanigen (NASDAQ:HGEN)
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