Humanigen Inc's (HGEN) Lenzilumab Selected by EU as One of 10 Most Promising COVID-19 Treatments

Humanigen, Inc. (Nasdaq: HGEN), 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 the European Commission identified lenzilumab as one of the “10 most promising treatments for COVID-19” in a report and press release issued on October 22, 2021.1,2

“We are gratified the European Commission has recognized the potential of lenzilumab to offer an important treatment option for patients hospitalized with COVID-19,” said Cameron Durrant, MD, Chairman and CEO, Humanigen. “We look forward to continuing our discussions with colleagues at the European Medicines Agency to advance our efforts to submit a marketing authorization application for lenzilumab in COVID-19. We are also progressing with our early access program, under compassionate use, where allowed by regulations in some European countries and the United States.”

*Lenzilumab is not authorized, or approved in any country, and as the European Commission notes, the selection of lenzilumab as a top-10 candidate “does not replace the scientific assessment by the European Medicines Agency, or the authorisation . . . by the European Commission.”2

Lenzilumab was chosen as one of the 10 most promising COVID-19 treatments after an evaluation of 82 late-stage therapeutic candidates by an independent group of 10 scientific experts across Europe. As described in the report, “these experts focused on the products with the highest potential impact on the pandemic.”1 Lenzilumab was one of only four immunomodulators selected that treats hospitalized patients. Although several other immunomodulators targeting GM-CSF were evaluated, lenzilumab is the only immunomodulator that targets GM-CSF to be selected by the European Commission for inclusion as one of the 10 most promising treatments for COVID-19.1

“We are pleased the report prepared by the European Commission’s independent experts recognizes the additional clinical value and reassuring safety profile of lenzilumab,” said Adrian Kilcoyne, MD, MPH, Chief Medical Officer, Humanigen. “The report also recognizes that lenzilumab is variant agnostic, a critically important consideration in the public health context.”

About the LIVE-AIR, Phase 3 Study of Lenzilumab

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 prevent or 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) and SWOV is an important clinical endpoint that measures not only mortality, but the morbidity associated with mechanical ventilation. Approximately 94% of patients received dexamethasone (or other steroids), 72% received remdesivir, and 69% received both.

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, with each infusion separated by eight hours over a 24-hour period. The LIVE-AIR study achieved its primary endpoint of survival without ventilation measured through day 28 following treatment (HR: 1.54; 95%CI: 1.02-2.32, p=0.0403). Results of the trial have been submitted for publication in a peer-reviewed journal.

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