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InflaRX set to file for MAA for vilobelimab

InflaRx plans to apply for Emergency Use Authorization from the US FDA in Q3/2022 for vilobelimab, the company’s treatment for critically ill COVID-19 patients.

Following talks with the US regulatory authority FDA, InflaRx N.V. announced plans to file its first-in-class anti-C5a monoclonal antibody vilobelimab, which has been tested in a Phase III study, for US market authorisation to treat critically ill, mechanically ventilated COVID-19 patients.

“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,” said Prof. Niels C. Riedemann, CEO and founder of InflaRx. “Our team has committed to submitting the request for an EUA by the end of Q3 2022 and is dedicated to achieving that ambitious goal.”

According to topline results from the company’s PANAMO Phase III study, 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 (n=368 patients), and a 43% relative reduction in patients from Western European countries (n=209). Thus, vilobelimab met the primary efficacy endpoint of 28-day all-cause mortality in the Western European but not the global population, that included also patients from Mexico, Peru, Brazil, and the Russian Federation.

Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, which effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism, which is not the case for molecules blocking the cleavage of C5. Vilobelimab has been demonstrated in pre-clinical studies to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response. Vilobelimab is believed to be the first monoclonal anti-C5a antibody introduced into clinical development. Vilobelimab has been shown to be well tolerated within clinical trials in different disease settings. Vilobelimab is currently being developed for various indications, including pyoderma gangrenosum and critical COVID-19. Vilobelimab is also in Phase II development for patients suffering from cutaneous squamous cell carcinoma.