NIH/NIAID Locks ACTIV-5/BET-B Database
Humanigen, Inc. (Nasdaq: HGEN) announced that the National Institute of Allergy and Infectious Diseases has completed the database lock for the Big Effect Trial of its lead drug candidate, lenzilumab, as part of the NIH's COVID-19 therapeutic initiative. This milestone allows for the completion of topline analysis, with results expected in July. Lenzilumab is being tested as a treatment for COVID-19 and is not yet approved. The study involves hospitalized patients and evaluates lenzilumab's safety and efficacy alongside remdesivir.
- Completion of database lock for lenzilumab trial is a significant milestone.
- Topline results from the trial are expected in July, potentially influencing stock performance.
- Lenzilumab is still investigational and not approved in any country.
“Locking the database marks a crucial step in the process of
Lenzilumab is an investigational product and is not approved or authorized in any country.
About ACTIV-5/BET-B
The Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV) is a
Within ACTIV-5, lenzilumab is the first and only anti-human GM-CSF treatment to be tested in ACTIV as a concomitant therapy with remdesivir compared with placebo plus remdesivir. Lenzilumab was selected from among 400 compounds that were considered for investigation in ACTIV.3 The study began in
About Lenzilumab
Lenzilumab is a proprietary Humaneered® first-in-class monoclonal antibody that has been proven to neutralize GM-CSF, a cytokine of critical importance in the hyperinflammatory cascade, sometimes referred to as cytokine release syndrome, or cytokine storm, associated with COVID-19 and other indications. Lenzilumab binds to and neutralizes GM-CSF, potentially improving outcomes for patients hospitalized with COVID-19. Positive data from LIVE-AIR demonstrated lenzilumab improved the likelihood of survival without the need for mechanical ventilation in hospitalized COVID-19 patients (HR=1.54, p=0.040).5 In LIVE-AIR, patients with a CRP < 150 mg/L derived the greatest benefit from lenzilumab demonstrating a
In CAR-T, lenzilumab successfully achieved the pre-specified primary endpoint at the recommended dose in a Phase 1b study with Yescarta® in which the overall response rate was
A study of lenzilumab is also underway for patients with chronic myelomonocytic leukemia (CMML) exhibiting RAS pathway mutations. This study builds on evidence from a Phase 1 study, conducted by
About
Forward-Looking Statements
This press release contains 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 anticipated time for release of topline data from the ACTIV-5/BET-B study and other statements regarding our plans relating to lenzilumab.
Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in the Company’s lack of profitability and need for additional capital to grow its business; the Company’s dependence on partners to further the development of its 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 or arbitration; and the various risks and uncertainties described in the "Risk Factors" sections of the Company’s latest annual and quarterly reports and other filings with the
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 press release 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.
References
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U.S. Department of Health and Human Services . (n.d.). Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV).National Institutes of Health . RetrievedJune 17, 2022 , from https://www.nih.gov/research-training/medical-research-initiatives/activ -
U.S. Department of Health and Human Services . (2022,June 2 ). Covid-19 Therapeutics prioritized for testing in clinical trials.National Institutes of Health . RetrievedJune 17, 2022 , from https://www.nih.gov/research-training/medical-research-initiatives/activ/covid-19-therapeutics-prioritized-testing-clinical-trials -
Collins, D. F. (2021,
February 16 ). ACTIV Update: Making major strides in covid-19Therapeutic Development . NIH Director's Blog. https://directorsblog.nih.gov/2021/02/16/activ-update-making-major-strides-in-covid-19-therapeutic-development/ (accessedJuly 30, 2021 ) -
Activ-5 / big effect trial (BET-B) for the treatment of COVID-19 - Full Text View. Full Text View - ClinicalTrials.gov. (2022,
February 28 ). RetrievedJune 2, 2022 , from https://www.clinicaltrials.gov/ct2/show/NCT04583969 - Temesgen, Z. et al. (2021). Lenzilumab in hospitalised patients with COVID-19 pneumonia (LIVE-AIR): a phase 3, randomised, placebo-controlled trial. The Lancet Respiratory Medicine. https://doi.org/10.1016/S2213-2600(21)00494-X
- Temesgen, Z., et al. (2022). Early lenzilumab treatment of COVID-19 patients using C-reactive protein as a biomarker improves efficacy: Results from the phase 3 ‘live-air’ trial. MedRxiv. https://doi.org/10.1101/2021.12.30.21267140
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Humanigen Investor Relations
trbo@humanigen.com
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FAQ
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