InflaRx Receives Positive CHMP Opinion for GOHIBIC® (Vilobelimab) for the Treatment of SARS-CoV-2-Induced Acute Respiratory Distress Syndrome
InflaRx received a positive CHMP opinion recommending marketing authorization for GOHIBIC® (vilobelimab) under exceptional circumstances for treating SARS-CoV-2-induced ARDS in adult patients. The treatment is specifically for patients receiving systemic corticosteroids and invasive mechanical ventilation. The European Commission is expected to issue marketing authorization within 67 days.
The recommendation is supported by Phase 3 PANAMO trial results, showing vilobelimab improved survival with a 23.9% relative reduction in 28-day all-cause mortality compared to placebo. InflaRx plans to commercialize GOHIBIC® in Europe and is considering commercial distribution options with potential partners, noting this approach won't significantly impact cash burn rate.
InflaRx ha ricevuto un parere positivo dal CHMP che raccomanda l'autorizzazione alla commercializzazione per GOHIBIC® (vilobelimab) in circostanze eccezionali per il trattamento del ARDS indotto da SARS-CoV-2 in pazienti adulti. Il trattamento è specificamente indicato per i pazienti che ricevono corticosteroidi sistemici e ventilazione meccanica invasiva. Si prevede che la Commissione Europea rilasci l'autorizzazione alla commercializzazione entro 67 giorni.
La raccomandazione è supportata dai risultati dello studio clinico di Fase 3 PANAMO, che mostrano che vilobelimab ha migliorato la sopravvivenza con una riduzione relativa del 23,9% nella mortalità per tutte le cause a 28 giorni rispetto al placebo. InflaRx prevede di commercializzare GOHIBIC® in Europa e sta considerando opzioni di distribuzione commerciale con potenziali partner, sottolineando che questo approccio non avrà un impatto significativo sul tasso di consumo di liquidità.
InflaRx recibió un dictamen positivo del CHMP recomendando la autorización de comercialización para GOHIBIC® (vilobelimab) en circunstancias excepcionales para el tratamiento del ARDS inducido por SARS-CoV-2 en pacientes adultos. El tratamiento está dirigido específicamente a pacientes que reciben corticosteroides sistémicos y ventilación mecánica invasiva. Se espera que la Comisión Europea emita la autorización de comercialización en un plazo de 67 días.
La recomendación está respaldada por los resultados del ensayo de fase 3 PANAMO, que muestran que vilobelimab mejoró la supervivencia con una reducción relativa del 23,9% en la mortalidad por todas las causas a los 28 días en comparación con el placebo. InflaRx planea comercializar GOHIBIC® en Europa y está considerando opciones de distribución comercial con socios potenciales, resaltando que este enfoque no tendrá un impacto significativo en la quema de efectivo.
InflaRx는 성인 환자의 SARS-CoV-2 유도 ARDS 치료를 위한 GOHIBIC® (vilobelimab)의 마케팅 승인을 권장하는 CHMP의 긍정적인 의견을 받았습니다. 이 치료는 전신 코르티코스테로이드와 침습적 기계 환기를 받는 환자에게 특히 적용됩니다. 유럽연합 집행위원회는 67일 이내에 마케팅 승인을 발급할 것으로 예상됩니다.
이 권장은 vilobelimab이 위약 대비 28일간의 모든 원인에 의한 사망률을 23.9% 상대적으로 감소시켜 생존율을 개선했다는 3상 PANAMO 시험 결과에 의해 뒷받침됩니다. InflaRx는 유럽에서 GOHIBIC®을 상용화할 계획이며 잠재적인 파트너와의 상업적 배급 옵션을 고려하고 있으며, 이 접근 방식이 현금 소모율에 큰 영향을 미치지 않을 것이라고 언급했습니다.
InflaRx a reçu un avis positif du CHMP recommandant l'autorisation de mise sur le marché pour GOHIBIC® (vilobelimab) dans des circonstances exceptionnelles pour le traitement du SDRAN induit par SARS-CoV-2 chez les patients adultes. Le traitement est spécifiquement destiné aux patients recevant des corticostéroïdes systémiques et une ventilation mécanique invasive. La Commission européenne devrait délivrer l'autorisation de mise sur le marché dans un délai de 67 jours.
Cette recommandation est soutenue par les résultats de l'essai PANAMO de phase 3, démontrant que le vilobelimab a amélioré la survie avec une réduction relative de 23,9 % de la mortalité toutes causes confondues à 28 jours par rapport au placebo. InflaRx prévoit de commercialiser GOHIBIC® en Europe et envisage des options de distribution commerciale avec des partenaires potentiels, en notant que cette approche n'affectera pas de manière significative le taux de consommation des liquidités.
InflaRx erhielt eine positive CHMP-Empfehlung, die die Marktzulassung für GOHIBIC® (vilobelimab) unter außergewöhnlichen Umständen zur Behandlung von SARS-CoV-2-induziertem ARDS bei erwachsenen Patienten empfiehlt. Die Behandlung ist speziell für Patienten vorgesehen, die systemische Kortikosteroide und invasive mechanische Beatmung erhalten. Die Europäische Kommission wird voraussichtlich innerhalb von 67 Tagen die Marktzulassung erteilen.
Die Empfehlung stützt sich auf die Ergebnisse der Phase-3-Studie PANAMO, die zeigen, dass vilobelimab die Überlebenschancen verbessert hat, mit einer relativen Reduktion der Gesamtmortalität um 23,9 % im Vergleich zu Placebo innerhalb von 28 Tagen. InflaRx plant, GOHIBIC® in Europa zu kommerzialisieren und prüft Optionen für die kommerzielle Vertriebsstrategie mit potenziellen Partnern, wobei betont wird, dass dieser Ansatz die Liquiditätsbelastung nicht signifikant beeinflussen wird.
- Received positive CHMP opinion recommending EU marketing authorization for GOHIBIC
- Phase 3 PANAMO trial showed 23.9% reduction in 28-day mortality rate
- Commercial strategy not expected to negatively impact cash burn rate
- Already has FDA Emergency Use Authorization in the US
- Marketing authorization is under 'exceptional circumstances' due to data limitations
- Required to provide annual updates to EMA on clinical platform study
- Serious adverse events reported including infections and hypersensitivity reactions
Insights
The CHMP positive opinion for GOHIBIC® (vilobelimab) represents a significant regulatory milestone for InflaRx. The recommendation for marketing authorization under exceptional circumstances for treating SARS-CoV-2-induced ARDS showcases strong clinical evidence, with the Phase 3 PANAMO trial demonstrating a
The potential EU approval, following the FDA's Emergency Use Authorization, opens access to a important market. However, the commercial impact may be by: 1) The specialized nature of the treatment (ICU patients on ventilation), 2) The declining severity of COVID-19 cases and 3) The company's need for distribution partnerships. The exceptional circumstances designation also requires ongoing data collection, adding operational complexity.
The safety profile appears manageable, with common adverse reactions including infections and cardiovascular events, typical for critically ill patients.
JENA, Germany, Nov. 15, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization of GOHIBIC (vilobelimab), 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 Company expects the European Commission to adopt the positive opinion and issue a marketing authorization within 67 days.
Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: “The positive CHMP opinion reflects a significant milestone in the development of our anti-C5a antibody vilobelimab, and, together with the previously received Emergency Use Authorization granted by the FDA, further validates its therapeutic potential. Patients in the ICU continue to die from SARS-CoV-2-induced ARDS, an important reminder of the ongoing need for more effective treatments for these patients. We are grateful to the intensive care physicians and patients’ families who worked with InflaRx on the PANAMO study.”
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 EU, which is anticipated early next year, 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.
InflaRx plans to commercialize the product in Europe under its proprietary brand name GOHIBIC®. As previously indicated, InflaRx is considering commercial distribution options with potential partners in the EU. InflaRx does not expect this approach will have a meaningfully negative impact on its cash burn rate.
The positive CHMP opinion 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
Important Information about GOHIBIC (vilobelimab)
GOHIBIC (vilobelimab) has been granted an Emergency Use Authorization by the U.S. 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 (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 ≥
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.
In addition to development in COVID-19, vilobelimab is also 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.
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 |
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FAQ
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