The FDA has granted emergency use authorization to InflaRx’s vilobelimab, now to be marketed as Gohibic, for hospitalized adult patients with COVID-19, the German biotech announced Tuesday.
Pictured: Medical professional giving COVID Test/Courtesy of Getty Images
The FDA has granted emergency use authorization (EUA) to InflaRx’s vilobelimab, now to be marketed as Gohibic, for hospitalized adult patients with COVID-19, the German biotech announced Tuesday.
These patients can only receive Gohibic when it is initiated within 48 hours of starting invasive mechanical ventilation or extracorporeal membrane oxygenation. InflaRx stated it will submit a Biologics License Application for Gohibic and seek its full approval.
Company shares surged 60% Tuesday afternoon in reaction to the news.
As vaccines and anti-viral drugs have become more accessible, COVID-19 has become more manageable. Still, some patients develop viral sepsis and progress to severe disease, requiring intensive care and breathing support, Niels Riedemann, CEO and founder, InflaRx, said in a statement.
Gohibic’s EUA will provide a new treatment option for approximately 2,000 patients who still die of COVID-19-related deaths per week, Riedemann said.
Gohibic is a first-in-class monoclonal antibody that blocks the activity of the complement factor C5a, which recruits and activates immune cells. This mode of action allows Gohibic to modulate the inflammatory process, which can become hyper-activated in COVID-19 and lead to complications.
Tuesday’s regulatory win will bring InflaRx in direct competition with other drugs meant to suppress overreactive inflammation in COVID-19. Among these are Eli Lilly’s Olumiant (baricitinib), the first JAK inhibitor approved for COVID-19, and Genentech’s Actemra (tocilizumab), another monoclonal antibody that transitioned from an EUA to full approval in December 2022.
Mixed Phase III Results
InflaRx supported Gohibic’s FDA bid with Phase III PANAMO trial data. A randomized, double-blinded, placebo-controlled trial with 369 participants, PANAMO is one of the most significant trials in COVID-19 patients needing mechanical ventilation.
All study participants received standard coronavirus care, including dexamethasone, immunomodulators and anti-coagulants.
In the initial read-out from PANAMO, posted in March 2022, Gohibic missed its primary efficacy bar. Compared with the placebo, the monoclonal antibody elicited a 24% relative reduction in 28-day all-cause mortality, an effect that was not statistically significant.
However, pre-specified and post-hoc analyses showed signs of significant efficacy. For instance, in the subgroup of patients from Western European countries, Gohibic yielded a relative risk reduction of 43% compared with placebo, which met statistical significance.
Gohibic also significantly lowered 28-day all-cause mortality in patients with more severe COVID-19 at the baseline, including those who needed at least one additional organ support, those with severe acute respiratory distress syndrome and poor lung function and those with impaired kidney function.
In July 2022, InflaRx announced plans to push through with an EUA application for Gohibic following a Type B meeting with the FDA.
