[ad_1]
-
Lenzilumab improved the relative likelihood of survival without invasive mechanical ventilation (IMV) by 54%, reaching the primary endpoint of the phase 3 study
-
Clinical improvement has been observed over other treatments including steroids and / or remdesivir
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on the prevention and treatment of an immune hyperresponse known as a “cytokine storm” with its lead drug candidate, lenzilumab, today announced positive results of its Phase 3 clinical trial evaluating the efficacy and safety of lenzilumab in patients hospitalized with COVID-19. Trial results showed that patients who received lenzilumab and other treatments, including steroids and / or remdesivir, had a 54% higher relative likelihood of surviving without use of IMV compared to patients receiving a placebo and other treatments. These results are statistically significant.
This press release contains multimedia. View the full version here: https://www.businesswire.com/news/home/20210329005301/en/
“The results of our Phase 3 clinical trial with lenzilumab treatment have been associated with better outcomes in hospitalized patients with hypoxic COVID-19 who had not yet progressed to the point of needing IMV,” said Cameron Durrant, MD, MBA, Managing Director, Humanigen. In addition, the trial incorporated a diverse population with various co-morbidities, most often a body mass index greater than 30, which is representative of an actual high-risk population. Our next step is to submit an application. Emergency Use Clearance (EUA) to the Food and Drug Administration (FDA) as soon as possible. We are also sharing these results with US government agencies and other authorities around the world. “
“The Mayo Clinic is thrilled to have participated in the lenzilumab investigation from the early days of the COVID-19 development program and is excited about this data,” said Andrew Badley, MD, professor of infectious diseases, and professor and chair of the Mayo Clinic molecular medicine department. “If lenzilumab is cleared for emergency use by the FDA, and based on our clinical trial experience to date, then it can be considered part of our treatment arsenal for newly hospitalized patients with COVID-19. “
The results of the study show that lenzilumab significantly improved patient outcomes. The study met its primary endpoint of ventilator-free survival measured through Day 28 after treatment (HR: 1.54; 95% CI: 1.03-2.33, p = 0.0365) . Ventilator-free survival is a validated and reliable measure used in studies that assess respiratory distress.1 The Kaplan-Meier estimate for VIM and / or death was 15.6% (95% CI: 11.5-21.0) in the lenzilumab arm versus 22.1% (95% CI: 17,4-27,9) in the placebo arm, i.e. a 54% improvement in the relative probability of survival without the need for IMV. Although this study could not demonstrate a difference in mortality, a favorable trend in mortality was observed: 9.6% (95% CI: 6.4-14.2) in the lenzilumab arm versus 13 , 9% (95% CI: 10.1-19.0) in the placebo arm (HR: 1.39; 95% CI: 0.82-2.39; p = 0.2287). About 88% of patients received dexamethasone (or other steroids), 62% received remdesivir, and 57% received both, balanced in both arms of the study. Serious Adverse Events (SAEs) were balanced in both study arms and the profile of SAEs was similar to that previously documented in previous studies with lenzilumab. In this study, lenzilumab appeared to be safe and well tolerated; no new SAEs have been identified and none have been attributed to lenzilumab.
“The data strongly suggests that lenzilumab improved outcomes for hospital patients with COVID-19 pneumonia,” said Zelalem Temesgen, MD, professor of medicine at the Mayo Clinic and principal investigator of the phase 3 trial. The dosage regimen used in this study was specifically designed for hospitalized patients with COVID-19 pneumonia as a potential baseline therapy. Lenzilumab could make the difference between going on a ventilator, which reduces the chances of survival, and leaving the hospital alive.
“It is impressive to see lenzilumab reach this milestone. At Emory University, a key center of the National Institutes of Health (NIH) ACTIV-5 study, currently in recruitment, we hope that lenzilumab will emerge as a valuable therapy for newcomers. there may be future opportunities to study lenzilumab in even larger trials, and to further explore the impact of lenzilumab on death rates, ”added Vincent Marconi, MD, professor of medicine at the School of Medicine from Emory University.
About the phase 3 study with lenzilumab
This study was a randomized, double-blind, placebo-controlled, multicentre phase 3 trial for the treatment and prevention of serious and life-threatening outcomes in patients hospitalized with COVID-19 pneumonia. The main objective was to assess whether lenzilumab, in addition to other treatments, which included dexamethasone (or other steroids) and / or remdesivir, could alleviate immune-mediated cytokine release syndrome (CRS). and improve ventilator-free survival. Respirator-free survival is a composite endpoint of time to death and time to VIM, which is a robust measure that is less inclined to favor treatment with discordant effects on survival or days without ventilation.1 The trial enrolled 520 patients at 29 sites in the United States and Brazil who were at least 18 years of age; blood oxygen saturation (SpO2) less than or equal to 94%; or low flow supplemental oxygen required, or high flow oxygen support, or non-invasive positive pressure ventilation (NIPPV); and were hospitalized but did not require an IMV. After enrollment, subjects were randomized to receive three infusions of lenzilumab or placebo, each infusion being separated by eight hours over a 24-hour period with other treatments. The primary endpoint was the difference between lenzilumab treatment and placebo treatment in ventilator-free survival for 28 days after treatment. Primary secondary endpoints, also measured over 28 days, included ventilator-free days, length 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. The results of the trial should be submitted for potential publication in a peer-reviewed journal.
About Humanigen, Inc.
Humanigen, Inc. is expanding its portfolio of clinical and preclinical therapies for the treatment of cancers and infectious diseases through its novel GM-CSF neutralization and gene neutralization platforms. Humanigen’s immediate goal is to prevent or minimize the cytokine release syndrome that precedes severe pulmonary dysfunction in hospitalized and hypoxic patients with COVID-19 pneumonia. Humanigen is also working to create next-generation combinatorial CAR-T therapies using strategies to improve efficacy while using GM-CSF gene deactivation technologies to control toxicity. In addition, Humanigen is developing its own portfolio of proprietary EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. Humanigen is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or by knockout of the GM-CSF gene) in combination with other CAR-T, bispecific T cells. or natural killers (NK). -initiate immunotherapy treatments to break the link between efficacy / toxicity, in particular to prevent and / or treat graft versus host disease (GvHD) in patients undergoing transplantation of allogeneic hematopoietic stem cells (HSCT). In addition, Humanigen and Kite, a Gilead company, are evaluating lenzilumab in combination with Yescarta® (axicabtagène ciloleucel) in patients with relapsed or refractory large B cell lymphoma in a clinical collaboration. For more information, visit www.humanigen.com and follow Humanigen on LinkedIn, Twitter and Facebook.
Humanigen forward-looking statements
All statements other than statements of historical fact contained in this press release are forward-looking statements. Forward-looking statements reflect the current knowledge, assumptions, judgment and expectations of management regarding future performance or events. Although management believes that the expectations reflected in these statements are reasonable, they provide 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 forward-looking statements. Words such as “will”, “expect”, “intend”, “plan”, “potential”, “possible”, “objectives”, “accelerate”, “continue” and similar expressions identify forward-looking statements, including without limitation, statements regarding our potential application for and receipt of emergency use authorization from the FDA for lenzilumab in COVID-19; and our other lenzilumab plans following the release of initial results.
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 our need for additional capital to grow our business; our dependence on partners to further develop our product candidates; uncertainties inherent in the development, obtaining the required regulatory authorizations and approvals and the launch of any new pharmaceutical product; the outcome of an ongoing or future litigation; and the various risks and uncertainties described in the “Risk Factors” sections of our most recent annual and quarterly reports and other documents filed with the SEC.
All forward-looking statements are expressly qualified in their entirety by this cautionary statement. You should not rely on forward-looking statements as predictions of future events. We assume no obligation to revise or update any forward-looking statements made in this presentation to reflect events or circumstances subsequent to the date hereof, to reflect new information or the occurrence of unforeseen events, to update the reasons why actual results could differ materially from these. provided for in forward-looking statements, in each case, except as required by law.
For media resources, including product images and the fact sheet, please click here.
___________________________
1 Novack V, Beitler JR, Yitshak-Sade M, Thompson BT, Schoenfeld DA, Rubenfeld G, et al. Alive and Ventilator Free: A hierarchical and composite result for clinical trials in acute respiratory distress syndrome. Intensive care medicine. 2020; 48 (2): 158-66
See the source version on businesswire.com: https://www.businesswire.com/news/home/20210329005301/en/
Contacts
Humanigen Media
Grace Catlett
RXMD
[email protected]
516-318-8563
Humanigen investors
Alan lada
Solebury Trout
[email protected]
617-221-8006
[ad_2]
Source link