InflaRx Presents New Analysis of PANAMO Phase III Trial in Severe COVID-19 at ATS 2024 Showing Potential Synergy With Vilobelimab When Used in Combination with Other Immunomodulators

JENA, Germany, May 21, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, announced data presented at the American Thoracic Society (ATS) 2024 International Conference that is being held from May 17-22, 2024 in San Diego.

InflaRx is presenting a poster at the thematic poster session at the ATS conference today from 11:30 AM PT / 2:30 PM ET to 1:15 PM PT / 4:15 PM ET. The poster is titled, “Vilobelimab in Combination with Tocilizumab or Baricitinib Dramatically Improves Mortality in Critically Ill COVID-19 Patients” and is being presented during the “ARDS and Acute Respiratory Failure: Mechanism, Risk, and Outcomes” thematic poster session.

The data being presented is derived from a post-hoc subgroup analysis of the PANAMO Phase III global study, one of the largest 1:1 randomized, double-blind placebo-controlled trials in invasively mechanically ventilated (IMV) COVID-19 patients in intensive care units in adult critically ill COVID-19 patients. Tocilizumab, an anti-IL6R antibody, and baricitinib, a JAK inhibitor, are immunomodulators used in some patients as part of the standard of care treatment in this trial. PANAMO included a total of 369 patients and was used to support the emergency use authorization (EUA) granted by the U.S. Food and Drug Administration (FDA) in April 2023 for GOHIBIC (vilobelimab) for the treatment of critically ill COVID-19 patients.

The analysis presented at ATS 2024 is comprised of 71 patients from PANAMO that assessed 28- and 60-day all-cause mortality in the subgroup of patients taking the combination of vilobelimab plus tocilizumab or baricitinib versus patients on placebo plus tocilizumab or baricitinib. All patients received standard of care. Safety was also assessed.

The point estimate for 28-day all-cause mortality was 6.3% in the vilobelimab plus tocilizumab or baricitinib arm, and 40.9% in the placebo plus tocilizumab or baricitinib arm: this is a significant relative reduction of 84.6% (HR 0.13; 95% CI:0.03-0.56, p=0.006) between the two arms. Day 60 all-cause mortality was 16.4% and 49.3%, respectively (HR 0.25; 95% CI:0.09-0.68, p=0.006), a significant relative reduction.

The co-administration of vilobelimab with baricitinib or tocilizumab was not associated with safety concerns. In addition, demographics of these subgroups were generally well-balanced and comparable to the overall study population.