- The Lancet Respiratory Medicine, a peer-reviewed journal, published the results of the PANAMO trial, one of the largest, global, 1:1 randomized, placebo-controlled Phase III studies conducted in invasively mechanically ventilated, critically ill COVID-19 patients
- In-depth statistical analysis confirms robustness of clinical survival benefit of vilobelimab treatment on 28-day and 60-day all-cause mortality
- Vilobelimab targets the inflammatory immune response evoked by SARS-CoV-2 infection that causes viral sepsis leading to organ failure
JENA, Germany, Sept. 08, 2022 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced that the previously reported results from its Phase III trial of vilobelimab to treat critically ill, invasively mechanically ventilated COVID-19 patients have been published in the peer-reviewed journal, The Lancet Respiratory Medicine. The publication can be accessed free of charge on The Lancet’s website.
Professor Dr. Martin Witzenrath, Co-chair of the Department of Infectious Diseases and Respiratory Medicine, Charité Universitätsmedizin Berlin, Germany, and investigator of the PANAMO study, commented: “We remain in urgent need of treatments that can help the most severely affected critically ill and invasively ventilated COVID-19 patients who suffer from a viral sepsis induced lung failure and who still show high mortality rates in the range of 40% despite the applied standard of care. The results of the PANAMO trial demonstrate a robust signal for improved survival with C5a inhibition in these highly vulnerable patients.”
The article describes the results from the Phase III, multicenter, randomized, double-blind, placebo-controlled PANAMO study. The PANAMO study is one of the largest 1:1 randomized, double-blind placebo-controlled trials that was powered to show a mortality difference as primary outcome measure in invasively mechanically ventilated COVID-19 patients in the intensive care unit. A total of 369 patients with COVID-19 on invasive mechanical ventilation were randomly assigned (1:1) to the vilobelimab treatment (six 800-mg infusions) or placebo group on top of standard of care, which included treatment with anti-coagulants, dexamethasone and immunomodulators. The published data show that vilobelimab treatment improved survival with a relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in the global data set.
In-depth statistical analysis confirms robustness of clinical survival benefit
The primary statistical analysis of the primary outcome 28-day mortality pre-specified in the statistical analysis plan (SAP) yielded a p-value of 0.0941 and, thus, missed the significance level. However, the original per-protocol planned method (p=0.0266), as well as multiple other comparable pre-specified or post-hoc analyses, yielded p-values of