InflaRx will still ask FDA to greenlight COVID treatment after phase 3 flop

You know the saying: if at first you don’t succeed, send it to the FDA anyway. 

Or something like that. 

Such is the mantra guiding InflaRx four months after the company's COVID-19 treatment vilobelimab failed a phase 3 study for the sickest patients. Yet after an “encouraging” meeting with the FDA, the company plans to apply for emergency use authorization (EUA) later this quarter, according to a Tuesday release. 

InflaRx said the FDA provided guidance on “deliverables” needed ahead of the EUA submission—although the company did not say whether that meant more data, a new study or any other potential actions. Additional discussions are expected to occur regarding further development of vilobelimab. Nonetheless, InflaRx’s top brass appears motivated. 

“Our constructive interactions with the FDA and the helpful guidance they provided have encouraged us to move forward with applying for EUA for vilobelimab in critically ill COVID-19 patients,” CEO Niels Riedemann said in a statement. 

In late March, InflaRx said that the late-stage trial for the C5a inhibitor monoclonal antibody failed the primary endpoint, which was based on a site-stratified analysis of 28-day all-cause death. That's a measure of how many people died for any reason within that time period, and while the original protocol did not stratify this data, the company amended the analysis to divvy up the data based on the site per the regulator's recommendation.

Riedemann said results from patients in Western Europe show a "robust signal" that the therapy improved survival over placebo, which was in line with results from a previous phase 2 trial. InflaRx previously reported the recommended statistical change but did not specify which agencies made the request.  

The drug is being tested in patients with severe COVID-19 who were mechanically ventilated and critically ill. It’s also being developed as a treatment for cutaneous squamous cell carcinoma and the skin disorder pyoderma gangraenosum. 

Investors seemed pleased with the plan to move forward. InflaRx's shares rose nearly 37% Tuesday morning to $1.91 apiece. 

In October, InflaRx reported receiving a more than $50 million grant from the German government to help the development of the treatment, part of a larger program aimed at creating more COVID therapies. At the end of the first quarter, the company had just north of $100 million on hand, enough to fund operations into the second half of 2024.