Biopharmaceutical company InflaRx NV’s monoclonal antibody has been granted emergency use authorization (EUA) by the Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults.
The FDA said on April 4 that it had issued the EUA for the use of Gohibic, a brand name of vilobelimab, a monoclonal anti-human complement factor C5a antibody, to be injected into hospitalized adults when initiated within 48 hours of them receiving artificial life support.
InflaRx said the EUA was granted based on the results of the multicenter phase 3 “PANAMO trial,” which it said 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 hospitalized in intensive care units (ICU).
During that trial, approximately 369 patients received either the vilobelimab treatment via six infusions of 800 milligrams, or a placebo. Both groups of patients also received the same standard of care, which included treatment with anticoagulants to prevent blood clots, dexamethasone to relieve inflammation, and other immunomodulators to calm the immune system, according to the company.
Data from that trial showed that patients treated with vilobelimab had a lower risk of death by day 28 and day 60 of treatment compared with those who received the placebo, according to the FDA.
Germany-based InflaRx said the reduction in the 28-day all-cause mortality rate compared to the placebo was 23.9 percent.
Vilobelimab is an investigational drug and has not been approved by the FDA for any indication including for the treatment of COVID-19. The company notes that there is “limited information” known about the safety and effectiveness of using the drug to treat people hospitalized with COVID-19.
According to the FDA, vilobelimab works by targeting part of the immune system that is thought to play a role in the inflammation that leads to COVID-19 disease progression.
The recommended dosage is 800 mg administered by intravenous infusion after dilution, given up to six times over the treatment period, starting the first dose within 48 hours of receiving artificial life support followed by further injections of days 2, 4, 8, 15, and 22, as long as the patient is still hospitalized, even if they have been discharged from ICU.
A factsheet for health care providers accompanying the drug (pdf) states that it has been associated with an “increase of serious infections” and that “hypersensitivity reactions have been reported.”
A long list of common adverse reactions to the drug have been reported and include pneumonia, sepsis, delirium, pulmonary embolism, hypertension, deep vein thrombosis, urinary tract infection, respiratory tract infection, and more, according to the fact sheet.
“COVID-19 treatments remain a priority for CDER, as the disease continues to impact the lives of Americans,” said Dr. Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research. “Today’s authorization offers another potentially life-saving treatment option for the sickest COVID-19 patients.”
Niels C. Riedemann, CEO and founder of InflaRx, said the company was “thrilled” that the FDA has issued an EUA for Gohibic and that the health agency recognizes the “lifesaving potential of this first-in-class drug.”
He added that despite the availability of vaccines and other COVID-19 treatments for the early stages of the virus, many patients are still developing viral sepsis and progressing to a critical status, often requiring invasive mechanical ventilation.
“As a consequence, we continue to see mortality rates in the range of approximately 2,000 COVID-19-reported deaths per week in the U.S. as reported by the U.S. Centers for Disease Control and Prevention,” Riedemann said. “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.”
According to the latest CDC data for the week ending March 29, there were 1,596 reported deaths from COVID-19 in the U.S.
InflaRx said it is continuing discussions with the FDA related to the submission of an application for full approval of Gohibic in this COVID-19 indication.
InflaRx has also completed “encouraging” meetings with members of the European Committee for Medicinal Products for Human Use related to a planned Marketing Authorization Application with the European Medicines Agency (EMA).
Additionally, the company is continuing to investigate other indications for Gohibic, including pyoderma gangrenosum, a rare skin condition that causes painful ulcers to develop, for which a phase 3 trial has been initiated.