InflaRx has received an emergency use authorisation (EUA) for Gohibic (vilobelimab) by the US Food and Drug Administration (FDA) to treat Covid-19 in hospitalised adults.

The EUA, filed in September 2022, has been granted for use within 48 hours of being given extracorporeal membrane oxygenation (ECMO) or invasive mechanical ventilation (IMV).

Gohibic is a monoclonal anti-human complement factor C5a antibody. It targets the part of the immune system that is responsible for inflammation that leads to Covid-19 disease progression.

The emergency use authorisation was based on the findings from the multicentre PANAMO phase 3 trial.

The late-stage trial demonstrated that patients treated with the investigational C5a antibody had a substantial relative reduction in 28-day all-cause mortality of around 24%. This was in comparison to placebo in Covid-19 patients who are critically ill and invasively mechanically ventilated.

InflaRx CEO and founder Niels Riedemann said: “We are thrilled and very proud that the FDA has issued an EUA for vilobelimab to treat this very sick patient group, recognising 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 2,000 Covid-19-reported deaths per week in the U.S. as reported by the U.S. Centers for Disease Control and Prevention.”

The PANAMO trial is a 1:1 randomised, double-blind placebo-controlled study in Covid-19 patients in intensive care units, who are invasively mechanically ventilated.

It randomised a total of 369 patients to the vilobelimab treatment arm or the placebo group.

InflaRx said that it continues to be in talks with FDA for the submission of a biologics license application (BLA) for the full approval of Gohibic in the Covid-19 indication.

Additionally, the clinical-stage biopharmaceutical company is developing the C5a antibody for other indications, including pyoderma gangrenosum, for which it is currently commencing a phase 3 clinical trial.