Shares of InflaRx (NASDAQ: IFRX) spiked 58% higher on Tuesday after the company announced that its first-in-class monoclonal anti-human complement factor C5a antibody, Gohibic (vilobelimab), received Emergency Use Authorization (EUA) from the FDA for the treatment of COVID-19 in hospitalized adults.

The company said that the drug targets complement factor C5a, a protein that plays a critical and often harmful role in the body's immune response.

The FDA granted the EUA based on the results of the company’s Phase III PANAMO trial, which was a randomized, double-blind placebo-controlled trial that enrolled 369 patients with COVID-19 who were invasively mechanically ventilated in the intensive care unit (ICU).

The data showed that Gohibic treatment significantly reduced 28-day all-cause mortality by 23.9% compared to placebo.

Both groups also received standard of care, including treatment with anti-coagulants, dexamethasone, and other immunomodulators. The data have been published in The Lancet Respiratory Medicine.

InflaRx Founder and CEO Prof. Niels C. Riedemann highlighted the need for this drug for critically ill COVID-19 patients who are still developing viral sepsis and progressing to critical status, which often requires invasive mechanical ventilation.

He stated that the EUA brings new hope to these patients and their loved ones, and they will work diligently to make this important new treatment available to patients as rapidly as possible.

InflaRx pointed out that it is currently in talks with the FDA regarding the submission of a Biologics License Application (BLA) for full approval of Gohibic in this COVID-19 indication.

The company has also completed meetings with the rapporteur and co-rapporteur teams of the European Committee for Medicinal Products for Human Use (CHMP) related to a planned Marketing Authorization Application with the European Medicines Agency (EMA).

The company stated that it has a supply of Gohibic available and is working to ramp up production at its third-party manufacturer to roll out supply in the U.S. as soon as possible.

Shares of InflaRx trade on the NASDAQ under the ticker symbol IFRX. For more information visit www.inflarx.de.