Clinical-stage biopharmaceutical company Humanigen Inc. (HGEN:NASDAQ), which is focused on developing therapies for treating infectious diseases and cancer, today announced "positive topline results from its Phase 3 clinical trial evaluating the efficacy and safety of lenzilumab in patients hospitalized with COVID-19."
The firm indicated that at present it is highly focused on the development of lenzilumab for use in the prevention and treatment of an immune hyper-response called cytokine storm, which often can be fatal in SARS-CoV-2 afflicted patients.
The company reported that participants in the Phase 3 study who were given lenzilumab in combination with both steroids and/or remdesivir experienced statistically significant higher survival rates without the need for intermittent mandatory ventilation (IMV) compared with patients who receiving placebo only together with the other baseline combined treatments.
Humanigen's CEO Cameron Durrant, M.D, M.B.A., stated "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...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 U.S. governmental agencies and other authorities worldwide."
Andrew Badley, M.D., professor of infectious diseases and professor and chair of the Department of Molecular Medicine at the Mayo Clinic, remarked, "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...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."
The firm reported that the results from the Phase 3 study demonstrated that lenzilumab significantly improved patient outcomes and successful achieved the pre-determined primary endpoint that established as "ventilator-free survival measured through day 28 following treatment." The company advised that patients treated with lenzilumab demonstrated a 54% improvement in the relative likelihood of survival without the need for IMV compared to the placebo group. Humanigen listed that "approximately 88% of patients received dexamethasone (or other steroids), 62% received remdesivir, and 57% received both, balanced across both arms of the study."
Principal Investigator of the Phase 3 trial Zelalem Temesgen, M.D., professor of medicine at Mayo Clinic, remarked, "The data strongly suggest that lenzilumab improved outcomes for hospitalized patients with COVID-19 pneumonia...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."
The company explained that the Phase 3 lenzilumab trial was randomized, multi-center study of 520 adult patients hospitalized with COVID-19 pneumonia conducted at 29 sites in the U.S. and Brazil. The main objective of the trial was to investigate potential treatment and prevention of serious and potentially fatal outcomes in hospitalized patients diagnosed with COVID-19 pneumonia.
Specifically, the primary goal was to assess whether lenzilumab together with steroids such as dexamethasone and/or therapeutic treatment with remdesivir would be able to counteract the immune-mediated cytokine release syndrome and thus improve chances for ventilator-free survival.
The predefined primary endpoint it the study was listed as "the difference between lenzilumab treatment and placebo treatment in ventilator-free survival through 28 days following treatment." The company advised that key secondary endpoints measured over a 28-day period 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."
Humanigen, Inc. is based in Burlingame, Calif., and concentrates its efforts on developing clinical and pre-clinical therapies to treat cancers and infectious diseases. The company asserted that "its 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 began the day with a market capitalization of around $748.3 million with approximately 53.48 million shares outstanding and a short interest of about 7.4%. HGEN shares opened greater than 57% higher today at $21.98 (+7.99, +57.11%) compared to Friday's $13.99 closing price. The stock has traded today between $19.53 and $29.20 per share and is currently trading at $23.44 (+$9.45, +67.55%).[NLINSERT]
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