InflaRx Unveils PANAMO Phase III Analysis in Severe COVID-19 at ATS 2024, Highlighting Vilobelimab Synergy with Immunomodulators

On May 21, 2024, InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company specializing in anti-inflammatory treatments targeting the complement system, presented promising new data at the American Thoracic Society (ATS) 2024 International Conference held in San Diego from May 17-22, 2024.

InflaRx's presentation at the thematic poster session, titled "Vilobelimab in Combination with Tocilizumab or Baricitinib Dramatically Improves Mortality in Critically Ill COVID-19 Patients," detailed significant findings from a post-hoc subgroup analysis of their PANAMO Phase III global study. This trial is one of the largest 1:1 randomized, double-blind, placebo-controlled studies conducted on invasively mechanically ventilated (IMV) COVID-19 patients in intensive care units.

The PANAMO study, which included a total of 369 patients, was instrumental in securing the emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for GOHIBIC (vilobelimab) in April 2023 for treating critically ill COVID-19 patients. The data presented at ATS 2024 focused on a subgroup of 71 patients who received either vilobelimab combined with tocilizumab or baricitinib, or a placebo combined with tocilizumab or baricitinib, with all patients receiving standard care. The analysis evaluated 28- and 60-day all-cause mortality and assessed safety.

The findings revealed a significant reduction in mortality rates for the vilobelimab treatment group. The 28-day all-cause mortality rate was 6.3% for patients receiving vilobelimab plus tocilizumab or baricitinib, compared to 40.9% for the placebo group. This represents an 84.6% reduction in mortality risk (HR 0.13; 95% CI: 0.03-0.56, p=0.006). At 60 days, the mortality rates were 16.4% for the vilobelimab group and 49.3% for the placebo group (HR 0.25; 95% CI: 0.09-0.68, p=0.006), indicating a substantial decrease in mortality risk.

Safety assessments showed no significant concerns with the co-administration of vilobelimab and either tocilizumab or baricitinib. The demographic characteristics of the subgroup were balanced and comparable to the overall study population.

Dr. Camilla Chong, Chief Medical Officer of InflaRx, expressed her enthusiasm: “I am thrilled that we can share this additional data from the PANAMO study, which will provide further scientific insights into the utility of vilobelimab when used with tocilizumab and baricitinib in critically ill hospitalized COVID-19 patients. We believe this analysis further supports the life-saving potential of vilobelimab in the acute care setting and indicates our continued commitment to these patients.”

Vilobelimab is a pioneering monoclonal antibody targeting human complement factor C5a, effectively blocking its biological activity and showing high selectivity. Unlike other molecules blocking C5, vilobelimab preserves the formation of the membrane attack complex (C5b-9), a crucial defense mechanism of the innate immune system. Preclinical studies have demonstrated that vilobelimab can control inflammation-driven tissue and organ damage by specifically inhibiting C5a, a key amplifier of the inflammatory response. Beyond COVID-19, vilobelimab is also being developed for other serious inflammatory conditions, including pyoderma gangrenosum and cutaneous squamous cell carcinoma.

Vilobelimab has received EUA for treating hospitalized adults with COVID-19 within 48 hours of receiving IMV or extracorporeal membrane oxygenation. This authorization is valid as long as the conditions justifying the emergency use of drugs and biological products during the COVID-19 pandemic persist, unless terminated or revoked sooner.

InflaRx, founded in 2007, is dedicated to discovering, developing, and commercializing potent inhibitors of complement activation factor C5a and its receptor C5aR. Their lead product, vilobelimab, has shown promising clinical activity and tolerability across multiple studies. Additionally, InflaRx is developing INF904, an orally administered small molecule inhibitor targeting C5a-induced signaling via the C5a receptor. The company operates from offices and subsidiaries in Jena and Munich, Germany, and Ann Arbor, MI, USA.