Humanigen Announces Target Enrollment in Phase 2/3 ACTIV-5/BET-B Trial of Lenzilumab for the Treatment of COVID-19 has Been Achieved
- Top-line data from ACTIV-5/BET-B expected to be announced late in the first quarter or early in the second quarter of 2022
- ACTIV-5/BET-B results to be shared with regulatory authorities in the US,
UK, and EU as part of the ongoing review process
- Lenzilumab is a variant-agnostic therapeutic that targets the dysregulated host immune response, an approach which may be of greater value than targeting the virus in hospitalized patients1
The ACTIV-5/BET-B study was designed to align with the Company’s Phase 3 study of its lead investigational product candidate, lenzilumab, in hospitalized patients with COVID-19 (“LIVE-AIR”), results of which recently were published in Lancet Respiratory Medicine, https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00494-X/fulltext.
Hospitalized COVID-19 patients enrolled in ACTIV-5/BET-B were randomized to receive either lenzilumab and remdesivir or placebo and remdesivir. Patients in both arms also received current standard of care for hospitalized COVID-19 patients, including corticosteroids. The primary analysis population in ACTIV-5/BET-B comprises all randomized patients with a baseline C-reactive protein (“CRP”) less than 150 mg/L, age < 85, and do not require mechanical ventilation at the time of enrollment. The primary endpoint of ACTIV-5/BET-B is the incidence of invasive mechanical ventilation or death through day 29. Analysis of the LIVE-AIR results demonstrated that patients with baseline CRP levels below 150 mg/L had even greater response to lenzilumab therapy, with a 62% relative reduction in the incidence of invasive mechanical ventilation or death (OR:0.38, 95%CI, 0.19-0.75, p = 0.005).
“Completion of target enrollment in ACTIV-5/BET-B is a significant milestone in the development of lenzilumab and we thank our colleagues at the
Additional information about the ACTIV-5/BET-B trial can be found at clinicaltrials.gov using Identifier NCT04583969.
Lenzilumab is an investigational product and is not approved or authorized in any country.
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 anticipated time for release of topline data from the ACTIV-5/BET-B study and, if favorable, submitting an amended EUA request, and other statements regarding our plans relating to lenzilumab.
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1. Leavis, H. et al. (2021). Comment: Stimulating severe COVID-19: the potential role of GM-CSF antagonism. The Lancet Respiratory Medicine. https://doi.org/10.1016/S2213-2600(21)00539-7
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