Data from Humanigen’s Phase 3 COVID-19 Trial Show 54% Increase in Survival Rates

Source: Streetwise Reports   03/29/2021

Shares of Humanigen Inc. traded 67% higher after the company reported positive topline results from its Phase 3 lenzilumab™ study indicating significant improvement in survival of hospitalized COVID-19 pneumonia patients without the need for mechanical ventilation.

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%).

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.