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.
Camilla Chong, MD, Chief Medical Officer of InflaRx, commented: "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."
About Vilobelimab
Vilobelimab is a first-in-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. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism of the innate immune system, which is not the case for molecules blocking C5. In pre-clinical studies, vilobelimab has been shown to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key "amplifier" of this response. In addition to development in COVID-19, vilobelimab is also being developed for various debilitating or life-threatening inflammatory indications, including pyoderma gangrenosum and cutaneous squamous cell carcinoma.
Important Information about GOHIBIC (vilobelimab)
Vilobelimab has been granted an EUA for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving IMV or extracorporeal membrane oxygenation.
The emergency use of GOHIBIC (vilobelimab) is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization revoked sooner.
Vilobelimab is an investigational drug that has not been approved by the FDA for any indication including for the treatment of COVID-19. There is limited information known about the safety and effectiveness of using GOHIBIC (vilobelimab) to treat people in the hospital with COVID-19. Please see additional information in the Fact Sheet for Healthcare Providers, Fact Sheet for Patients and Parents/Caregivers and FDA Letter of Authorization on the GOHIBIC (vilobelimab) website ().
Important Safety Information about GOHIBIC (vilobelimab)
There is limited clinical data available for GOHIBIC (vilobelimab). Serious and unexpected adverse events (AEs) may occur that have not been previously reported with GOHIBIC (vilobelimab) use.
GOHIBIC (vilobelimab) has been associated with an increase of serious infections. In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment with GOHIBIC (vilobelimab). Hypersensitivity reactions have been observed with GOHIBIC (vilobelimab). If a severe hypersensitivity reaction occurs, administration of GOHIBIC (vilobelimab) should be discontinued and appropriate therapy initiated.
The most common adverse reactions (incidence ≥3%) are pneumonia, sepsis, delirium, pulmonary embolism, hypertension, pneumothorax, deep vein thrombosis, herpes simplex, enterococcal infection, bronchopulmonary aspergillosis, hepatic enzyme increased, urinary tract infection, hypoxia, thrombocytopenia, pneumomediastinum, respiratory tract infection, supraventricular tachycardia, constipation, and rash.
Healthcare providers and/or their designee are responsible for mandatory FDA MedWatch reporting of all medication errors and serious AEs or deaths occurring during GOHIBIC (vilobelimab) treatment and considered to be potentially attributable to GOHIBIC (vilobelimab).
Report side effects to the FDA at 1-800-FDA-1088 or . In addition, side effects can be reported to InflaRx at: pvusa@inflarx.de