New treatment for critically ill COVID-19 patients receives EUA in the US

By Rachel Arthur

- Last updated on GMT

The drug is authorized for hospitalized patients. Pic: getty/tirc83
The drug is authorized for hospitalized patients. Pic: getty/tirc83

Related tags COVID-19 Monoclonal antibody Monoclonal antibodies

InflaRx’s Gohibic (vilobelimab), a monoclonal anti-human complement factor C5a antibody, has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults.

Despite the availability of vaccines and treatments, many COVID-19 patients still develop viral sepsis and progress to critical status: with around 2,000 COVID-19 deaths still reported per week in the US.

The drug becomes the first authorized to control complement factor C5a, a protein that plays an important and often harmful role in the body’s immune response.

Reduction in mortality of 23.9%

Gohibic has been approved for hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).

Data supporting the EUA were based on the multicenter Phase III PANAMO trial. A total of 369 patients were randomly assigned to the vilobelimab treatment group (six 800-mg infusions) or the placebo group. Both groups also received standard of care, which included treatment with anti-coagulants, dexamethasone and other immunomodulators.

The data, published in The Lancet Respiratory Medicine,​ showed that vilobelimab treatment improved survival with a relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in the global data set.

InflaRx says it has a supply of Gohibic (vilobelimab) available and is working to ramp up production at its third-party manufacturer to roll out supply in the US as soon as possible.

It also continues discussions with FDA related to submission of a BLA for full approval of Gohibic in this COVID-19 indication. InflaRx has also completed encouraging 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).

From influenza to COVID-19

InflaRx – which is made up of subsidiaries in Germany and the US – is focused on applying its proprietary anti-C5a / C5aR technologies to discover and develop first-in-class or best-in-class, potent and specific inhibitors of C5a and C5aR (identifying complement C5a and its receptor C5aR as powerful inflammatory mediators involved in the progression of a wide variety of autoimmune and other inflammatory diseases).

“This Emergency Use Authorization (EUA) recognizes our research with Vilobelimab in COVID-19, which is based on more than two decades of ground-breaking scientific work related to the complement factor C5a, a protein that plays an important and often harmful role in the body’s immune response in sepsis and autoimmune diseases,” Prof. Niels C. Riedemann, CEO and Founder of InflaRx, told us.

“Gohibic (vilobelimab) is now the first authorized drug to control the complement Factor C5a, an important and often very harmful part of our body's innate immune response.”

Founded in 2007, the company pivoted to COVID-19 treatments on the back of promising data for vilobelimab with influenza.

“As early as 2015, together with researchers in China, InflaRx had reported important data with vilobelimab in treating influenza A (H7N9) virus-induced acute lung injury," said Riedemann.

"In 2018, they also reported the important roles of C5a/C5aR axis in developing viral pneumonia induced by MERS-COV. With these data plus early clinical data in sepsis, InflaRx decided at the outset of the COVID-19 pandemic to evaluate the potential of vilobelimab to treat the most seriously affected intubated patients suffering from viral sepsis.

“In March 2020, InflaRx initiated a randomized Phase II study in critically ill COVID-19 patients with the goal of determining the potential of vilobelimab in this indication and using the information from the trial to design and conduct a multinational Phase III trial involving different continents.”

Development has continued in other indications in parallel, including in oncology and pyoderma gangrenosum, where a Phase III trial is expected to begin enrolling patients around mid-2023.

“We are also evaluating the broadening of research to potential future applications in other viral lung injury and viral sepsis-causing diseases, including those where the mechanism has already been confirmed in pre-clinical models,” said Riedemann.

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