FDA Grants EUA for Vilobelimab for Treatment of Critically Ill Patients With COVID-19

The first-in-class monoclonal anti-human complement factor C5a antibody vilobelimab (Gohibic; InflaRx NV), has been granted an emergency use authorization (EUA) by the FDA for the treatment of COVID-19 in hospitalized patients, when the drug is administered within 48 hours of the patient receiving either invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO).

“We are thrilled and very proud that the FDA has issued an EUA for vilobelimab to treat this very sick patient group, recognizing the lifesaving potential of this first-in-class drug. Despite the availability of vaccines and other treatments for earlier disease stages of COVID-19, many patients are still developing viral sepsis and are progressing to critical status, which often requires invasive mechanical ventilation. As a consequence, we continue to see mortality rates in the range of approximately 2000 COVID-19-reported deaths per week in the [United States] as reported by the US Centers for Disease Control and Prevention,” said Niels C. Riedemann, MD, PhD, CEO and founder of InflaRx, in a press release. “Today’s announcement brings new hope to these patients and their loved ones, and we will work diligently to make this important new treatment available to patients as rapidly as possible.”

The FDA granted the EUA based on the results of the multicenter phase 3 PANAMO trial, which is one of the largest 1:1 randomized, double-blind placebo-controlled trials investigating treatments for invasively mechanically ventilated patients with COVID-19 who are in intensive care units. During the trial, investigators enrolled a total of 369 patients who were randomly assigned to either the vilobelimab treatment group, who were given 6 infusions of vilobelimab at 800-mg, or the placebo group. However, both groups also received standard of care to ensure they were still receiving treatment. The standard of care for this patient population included treatment with anti-coagulants, dexamethasone, and other immunomodulators.

Data from the PANAMO trial demonstrated that treatment with vilobelimab was able to improve survival compared to placebo, with a reduction in 28-day all-cause mortality of 23.9%. These data have been published in The Lancet Respiratory Medicine.

Discussions between InflaRx and the FDA regarding the submission of a BLA for full approval of vilobelimab in this COVID-19 indication remain ongoing. Additionally, the company is continuing to investigate other indications for vilobelimab, including pyoderma gangrenosum, for which a phase 3 trial has been initiated.

“This EUA is a great recognition of our COVID-19-related research, which was based on over 2 decades of groundbreaking work on the tissue and organ-damaging effect of the complement factor C5a as part of the body’s immune response. InflaRx will evaluate broadening our development of vilobelimab in other areas of viral lung injury and viral sepsis where the mechanism has already been researched in pre-clinical models,” Renfeng Guo, MD, chief scientific officer and founder of InflaRx, said in the press release. “Our COVID-19 results underscore the anti-inflammatory potential of inhibition of the terminal C5a and C5a receptor pathway in other inflammatory diseases.”

Reference

InflaRx Receives FDA Emergency Use Authorization for Gohibic (vilobelimab) for Treatment of Critically Ill COVID-19 Patients. Jena, Germany: InflaRx NV; April 4, 2023. In email. Accessed April 4, 2023.