InflaRx Receives European Commission Approval for GOHIBIC® (vilobelimab) for the Treatment of SARS-CoV-2-Induced Acute Respiratory Distress Syndrome (ARDS)

Rhea-AI Summary

InflaRx (NASDAQ: IFRX) has received European Commission marketing authorization under exceptional circumstances for GOHIBIC® (vilobelimab), the first approved treatment in the European Union for SARS-CoV-2-induced acute respiratory distress syndrome (ARDS). The approval applies to adult patients receiving systemic corticosteroids and invasive mechanical ventilation, with or without ECMO.

The authorization is supported by Phase 3 PANAMO trial results, which demonstrated a 23.9% relative reduction in 28-day all-cause mortality compared to placebo. The approval covers all 27 EU member states plus Iceland, Liechtenstein, and Norway. InflaRx is exploring commercial partnering options in the EU.

In the US, GOHIBIC has received Emergency Use Authorization from the FDA for COVID-19 treatment in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or ECMO.

Positive

• First approved treatment in EU for SARS-CoV-2-induced ARDS
• Phase 3 trial showed 23.9% reduction in 28-day mortality
• Marketing authorization covers 30 European countries
• Emergency Use Authorization already granted in US market

Negative

• Marketing authorization granted under 'exceptional circumstances' due to data limitations
• Company still needs commercial partners for EU distribution
• Safety concerns including increased risk of serious infections
• clinical data available for the treatment

Insights

Medical Research Analyst

The European Commission's approval of GOHIBIC® (vilobelimab) represents a major regulatory milestone for InflaRx. This is particularly significant as it's the first approved treatment in the EU for SARS-CoV-2-induced ARDS, addressing a critical unmet medical need. The Phase 3 PANAMO trial data showing a 23.9% relative reduction in 28-day all-cause mortality demonstrates compelling clinical efficacy.

The 'exceptional circumstances' marketing authorization, while reflecting the drug's potential in a rare but severe condition, also indicates some limitations in data collection due to the nature of the disease. The approval spans all 27 EU member states plus Iceland, Liechtenstein and Norway, creating a substantial market opportunity. However, InflaRx's strategy to pursue commercial partnerships rather than direct commercialization suggests a conservative approach to market entry.

The safety profile appears manageable, with most adverse reactions being consistent with the severe nature of COVID-19 ARDS. The existing U.S. Emergency Use Authorization provides additional validation of the treatment's potential.

Financial Analyst

This EU approval significantly enhances InflaRx's commercial potential, though the impact on immediate financials may be moderate. The company's market cap of $140.7M appears modest considering this regulatory achievement. Key financial implications include:

1. The partnership strategy for EU commercialization should help preserve cash reserves while potentially generating licensing revenues and royalties.
2. The 'exceptional circumstances' designation could accelerate market access but might impact pricing and reimbursement negotiations.
3. The company's statement about minimal impact on cash burn rate suggests efficient resource management.

For a small-cap biotech, having two major market approvals (EU and US EUA) for GOHIBIC strengthens the company's negotiating position with potential commercial partners. This could lead to more favorable deal terms and potentially attract larger pharmaceutical companies for partnerships or strategic transactions.

JENA, Germany, Jan. 15, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced that the European Commission (EC) has granted marketing authorization under exceptional circumstances for GOHIBIC^® (vilobelimab) for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation (IMV) with or without extracorporeal membrane oxygenation (ECMO). GOHIBIC is the first and only treatment approved in the European Union for the treatment of SARS-CoV-2-induced ARDS.

Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: “The European Commission’s approval of GOHIBIC, the first approval of its kind, reflects our commitment to ICU patients with SARS-CoV-2-induced ARDS, a pressing medical setting in need of more effective therapeutic options. I would like to thank the entire InflaRx team for its dedication and diligence resulting in this successful marketing authorization, and we are grateful for the support provided by the intensive care physicians, patients and their families who participated in the PANAMO study which supported the marketing authorization application.”

The marketing authorization under exceptional circumstances for GOHIBIC is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway. InflaRx is considering commercial partnering and distribution options in the EU and does not expect this approach will have a meaningfully negative impact on its cash burn rate.

Important Information about GOHIBIC (vilobelimab)

In the EU, GOHIBIC (vilobelimab) has been granted marketing authorization under exceptional circumstances for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation (IMV) (with or without extracorporeal membrane oxygenation (ECMO)). The EU approval of GOHIBIC is supported by the previously announced results of the multicenter Phase 3 PANAMO trial, one of the largest 1:1 randomized, double-blind, placebo-controlled trials in invasively mechanically ventilated COVID-19 patients in intensive care units. The results showed 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. The data were published in The Lancet Respiratory Medicine.

A marketing authorization under exceptional circumstances is recommended when the benefit/risk assessment is determined to be positive but, due to the rarity of the disease, it’s unlikely that comprehensive data can be obtained under normal conditions of use. Under the terms of GOHIBIC’s approval in the EC, InflaRx will provide annual updates to EMA on the previously announced clinical platform study planned by the Biomedical Advanced Research and Development Authority (BARDA). Vilobelimab is included in this study as one of three new potential therapies for treating ARDS.

In the U.S., GOHIBIC (vilobelimab) has been granted an Emergency Use Authorization by the Food and Drug Administration (FDA) 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.

GOHIBIC (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 http://www.gohibic.com.

Important Safety Information about GOHIBIC (vilobelimab)

There are limited clinical data available for GOHIBIC. Serious and unexpected adverse events (AEs) may occur that have not been previously reported with GOHIBIC use.

GOHIBIC 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. Hypersensitivity reactions have been observed with GOHIBIC. If a severe hypersensitivity reaction occurs, administration of GOHIBIC 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 that occur during GOHIBIC treatment and are considered to be potentially attributable to GOHIBIC.

Report side effects to the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. In addition, side effects can be reported to InflaRx at: pvusa@inflarx.de. 

For the full prescribing information and additional important safety information, please visit www.GOHIBIC.com.

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.

Vilobelimab is being developed for various debilitating or life-threatening inflammatory indications, including pyoderma gangrenosum (PG). Vilobelimab has been granted orphan drug designation for the treatment of PG by both the FDA and the EMA, as well as fast track designation by the FDA.

The COVID-19 related work described herein is partly funded by the German Federal Government through grant number 16LW0113 (VILO-COVID). All responsibility for the content of this work lies with InflaRx.

About InflaRx

InflaRx (Nasdaq: IFRX) is a biopharmaceutical 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 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.com.

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

Contacts:

InflaRx N.V.	MC Services AG
Jan Medina, CFA Vice President, Head of Investor Relations Email: IR@inflarx.de	Katja Arnold, Laurie Doyle, Dr. Regina Lutz Email: inflarx@mc-services.eu Europe: +49 89-210 2280 U.S.: +1-339-832-0752

FORWARD-LOOKING STATEMENTS

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FAQ

What is the effectiveness of IFRX's GOHIBIC in treating COVID-19 ARDS?

GOHIBIC demonstrated a 23.9% relative reduction in 28-day all-cause mortality compared to placebo in the Phase 3 PANAMO trial for patients with SARS-CoV-2-induced ARDS.

What are the main side effects of IFRX's GOHIBIC treatment?

Common adverse reactions (≥3%) include pneumonia, sepsis, delirium, pulmonary embolism, hypertension, pneumothorax, deep vein thrombosis, and various infections.

What is the scope of IFRX's European marketing authorization for GOHIBIC?

The authorization covers all 27 EU member states plus Iceland, Liechtenstein, and Norway, for treating adult patients with SARS-CoV-2-induced ARDS receiving corticosteroids and mechanical ventilation.

How does IFRX's GOHIBIC approval in the EU differ from its US status?

In the EU, GOHIBIC has full marketing authorization under exceptional circumstances, while in the US it has Emergency Use Authorization for COVID-19 treatment when initiated within 48 hours of mechanical ventilation.