InflaRx’s GOHIBIC (Vilobelimab) Selected for First BARDA-Sponsored Clinical Trial to Evaluate Novel Host-Directed Therapeutics for Acute Respiratory Distress Syndrome (ARDS)

2024-06-25

研发

临床研究

June 24, 2024 -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, announced today that GOHIBIC (vilobelimab) has been selected by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, as one of three investigational therapies to be assessed in a Phase 2 clinical platform study exploring potential new options for the treatment of acute respiratory distress syndrome (ARDS).

Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: “It’s a tremendous privilege for InflaRx that BARDA has chosen vilobelimab for inclusion in this pioneering ARDS program. ARDS is one of the most pressing unmet needs in critical care today, with no approved therapy, and we’re delighted to expand our dedication to the community with this study made possible by this non-dilutive path to trial participation. Given vilobelimab’s potent inhibition of C5a and a host-directed mechanism of action, we believe it has the potential for broader applicability as a potent anti-inflammatory agent in ARDS."

The Phase 2 multicenter, randomized, double-blind, placebo-controlled trial is expected to begin later this year. It is carried out by a global clinical research organization (CRO), PPD Development, LP (a clinical research business of Thermo Fisher Scientific, Inc.), contracted by BARDA. The trial is expected to be conducted at approximately 60 sites in the U.S., with a total target enrollment of 600 hospitalized adults with ARDS. Enrollment will include ARDS due to any etiology other than trauma, large volume aspiration, or transfusion. ARDS severity will be defined prospectively.

Vilobelimab,which will be supplied by InflaRx from its available stock, will be one of three host-directed investigational drugs assessed in this study, with the safety and efficacy of each investigational drug to be studied in its own patient cohort and compared against placebo. Each cohort is expected to enroll 200 patients (100 on investigational drug and 100 on placebo), with both arms in each cohort including standard of care as background therapy.

The primary endpoint will be all-cause mortality at Day 28, with additional efficacy endpoints to include all-cause mortality at additional time periods, days of hospitalization, days in the ICU, daily oxygenation requirements, invasive mechanical ventilation endpoints, as well as other efficacy endpoints and biomarker measures.

This Phase 2 platform study will collect data in order to define subsets of patients with ARDS who may benefit from specific host-directed therapeutics. These data will inform the design of Phase 3 studies and identify a patient subpopulation most likely to benefit from each of the three drug candidates.

About ARDS

ARDS is a life-threatening lung condition with multiple causes, including severe pneumonia and sepsis due to bacterial and viral infections such as influenza and SARS-CoV-2, that leads to high rates of death among hospitalized patients. ARDS is believed to be driven by the body’s immune response to an underlying inflammatory insult, also known as host response, which has been demonstrated to contribute to lung inflammation and tissue damage in multiple pre-clinical studies. Currently, no approved or licensed medications are available to treat ARDS.

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.

About C5a in ARDS

Observational and pre-clinical studies have suggested that the inflammatory host response, the associated tissue damage through endothelial permeability increase, and coagulopathy observed in ARDS are associated with strong complement activation and C5a generation as part of the innate immune response. By targeting the complement component C5a, vilobelimab is believed to block a key mediator of this inflammatory host response and, thus, potentially offers a mechanism of action that may be relevant to organ damage and associated mortality in ARDS. Inhibition of the C5a / C5aR pathway has been demonstrated to be beneficial or lifesaving in various pre-clinical models of viral lung injury and viral sepsis, including studies investigating vilobelimab in influenza, as well as chemically induced lung damage. A recent placebo-controlled, 1:1 randomized, multinational, multicenter study in patients with evidence of SARS-CoV-2 infection who required invasive mechanical ventilation (IMV) or lung replacement therapy (ECMO) has demonstrated a significant 28-day and 60-day survival improvement, which was the basis for an emergency use authorization (EUA) of GOHIBIC (vilobelimab).

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 ECMO.

The emergency use of GOHIBIC 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 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 website (www.GOHIBIC.com).

About InflaRx N.V.:

InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx).

InflaRx (Nasdaq: IFRX) is a biotechnology company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5aR technologies to discover, develop, and commercialize highly potent and specific inhibitors of the complement activation factor C5a and its receptor C5aR. C5a is a powerful inflammatory mediator involved in the progression of a wide variety of inflammatory diseases. InflaRx’s lead product candidate, vilobelimab, is a novel, intravenously delivered, first-in-class, anti-C5a monoclonal antibody that selectively binds to free C5a and has demonstrated disease-modifying clinical activity and tolerability in multiple clinical studies in different indications. InflaRx is also developing INF904, an orally administered small molecule inhibitor of C5a-induced signaling via the C5a receptor. InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information, please visit www.inflarx.de.

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