A biopharmaceutical company developing anti-inflammatory therapeutics announced today (July 26) that it is going to submit a request for Emergency Use Authorization (EUA).
InflaRx made the announcement after encouraging interactions with the US Food and Drug Administration (FDA) at a recent meeting.
The company had requested the meeting to discuss a potential EUA submission regarding the development of its anti-C5a monoclonal antibody vilobelimab in critically ill, invasively mechanically ventilated COVID-19 patients.
While with the FDA, the company discussed in detail the completed phase 3 part of the PANAMO study in COVID-19 patients.
InflaRx also obtained guidance from the agency on deliverables related to its planned submission for EUA. It also committed to additional discussions with the agency regarding its further development of vilobelimab for the ventilated COVID-19 patients.
Professor Niels C. Riedemann, CEO and founder of InflaRx said: “With emerging COVID-19 variants and cases and hospitalizations again on the rise, there remains an urgent need for new treatment options, especially for the sickest patients who suffer from an inflammatory response, leading to organ failure.
“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. Our team has committed to submitting the request for an EUA by the end of the third quarter of 2022 and is dedicated to achieving that ambitious goal.”
The company had previously announced encouraging topline results from the PANAMO phase 3 study, an international, double-blind, placebo-controlled, randomized clinical trial investigating vilobelimab in invasively mechanically ventilated COVID-19 patients.
The primary efficacy endpoint was 28-day all-cause mortality. In this trial, vilobelimab treatment resulted in a 23.9% relative reduction in 28-day all-cause mortality when compared to the placebo arm in the global data set in 368 patients.
A pre-specified analysis of patients from 209 Western European countries showed a 43% relative reduction in 28-day all-cause mortality in the vilobelimab treatment arm when compared to the placebo arm.
Vilobelimab is a class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood.