Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1718 |
| INN | Vilobelimab |
| Status | Regulatory review |
| Drug code(s) | BDB-001, IFX-1, CaCP29 |
| Brand name | Gohibic |
| mAb sequence source | mAb chimeric |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | Complement C5a |
| Indications of clinical studies | Squamous Cell Carcinoma, COVID-19, Pyoderma Gangrenosum, ANCA-associated vasculitis, hidradenitis suppurativa, complex cardiac surgery, Sepsis |
| Primary therapeutic area | Cardiovascular / hemostasis disorders |
| Most advanced stage of development (global) | Regulatory review EU |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | March 15, 2011 |
| Start of Phase 2 | February 15, 2014 |
| Start of Phase 3 | March 31, 2020 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | Vilobelimab |
| US or EU approved indications | None |
| Company | Inflarx |
| Licensee/Partner | Staidson (Beijing) Biopharmaceuticals Co. Ltd |
| Comments about company or candidate | EMA evaluation started Aug 17, 2023; pos opinion issues in mid-Nov 2024. August 30, 2023 – InflaRx N.V. announced that the Company has submitted a Marketing Authorization Application (MAA) for the treatment of adult patients with SARS-CoV-2 induced septic acute respiratory distress syndrome (ARDS) receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) and that the European Medicines Agency (EMA) has validated the MAA. June 2023 Inflarx presentation: Phase III in pyoderma gangrenosum (NCT05964413) started - FPI expected in mid 2023 (trial design fixed upon FDA discussions). OD and FT status in US, OD status EMA. 4/4/2023: FDA has issued an emergency use authorization (EUA) for the use of Gohibic (vilobelimab) injection for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (artificial life support). Sep 2022: InflaRx N.V. submitted a request for Emergency Use Authorization (EUA) for vilobelimab following encouraging interactions with the US Food and Drug Administration (FDA) at a Type B meeting held this summer. Additionally, InflaRx has been granted Fast Track designation from the FDA for vilobelimab for the treatment of critically ill, intubated, mechanically ventilated COVID-19 patients. The EUA submission and Fast Track designation are based on the results of the PANAMO trial, one of the largest, global, 1:1 randomized, placebo-controlled Phase III studies conducted in invasively mechanically ventilated, critically ill COVID-19 patients. “Gohibic” conditionally accepted by FDA as proprietary name for vilobelimab July 06, 2022: InflaRx N.V. announced that the US Food and Drug Administration granted a Fast Track designation to the development of its first-in-class anti-C5a monoclonal antibody vilobelimab for the treatment of ulcerative pyoderma gangrenosum. January 5, 2022: InflaRx N.V. announced the initiation of the Phase III program with vilobelimab in hidradenitis suppurativa (HS) patients with active draining tunnels. Sep 2021: InflaRx N.V. a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announces its plan to proceed with a pivotal development program for vilobelimab in Hidradenitis Suppurativa (HS) after a successful Type A meeting with the US Food and Drug Administration (FDA) and receipt of the official meeting minutes. NCT04449588 is a Phase 2/3 study of BDB-001 injection in severe COVID-19 with severe pneumonia, or acute lung injury/acute respiratory distress syndrome. Primary completion date is Aug 2021. Sponsor is Staidson (Beijing) Biopharmaceuticals Co., Ltd; collaborator is Beijing Defengrei Biotechnology Co. Ltd. InflaRx received initial positive human data from its licensee, Beijing Defengrei Biotechnology Co. Ltd. (BDB), suggesting a potential role of C5a in COVID-19 June 2021: InflaRx N.V., a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced the enrollment of the first patient in an open-label, multicenter Phase II clinical study evaluating vilobelimab alone and in combination with pembrolizumab in patients with PD-1 or PD-L1 inhibitor resistant/refractory locally advanced or metastatic cutaneous squamous cell carcinoma NCT04333420 Phase 2/3 in COVID-19 started in March 2020. Primary completion date is Sep 2021. Topline data for all 360 enrolled patients at the 28-day mortality primary endpoint from the trial are expected to be available by the end of 2021. March 31, 2020 – InflaRx N.V. , a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced the enrollment of the first patient into a randomized clinical trial investigating the safety and efficacy of IFX-1, the company´s monoclonal anti-C5a antibody, in patients with severe COVID-19-induced pneumonia. The company has received initial positive human data from two initial patients suffering from COVID-19-induced severe pneumonia who were treated with BDB-001, an anti-C5a antibody produced by BDB from the IFX-1 cell line, in China. Data from the two patients are part of a larger investigation on the role of complement activation in COVID-19 which have been made publicly available through a pre-print server and have not been independently validated by InflaRx. NCT03971643 Phase 2 study in Pyoderma Gangrenosum started in May 2019. NCT03895801 Phase 2 study in Granulomatosis With Polyangiitis and Microscopic Polyangiitis started in March 2019. Feb 2019: InflaRx anticipates key results of the international Phase IIb study in the second quarter of 2019. October 30, 2018 – InflaRx N.V., a biopharmaceutical company developing innovative therapeutics to treat devastating inflammatory diseases by targeting the complement system, a key component of the innate immune system, today announced that the first patient has been dosed in a phase II study to determine the safety and efficacy of IFX-1, a first-in-class anti-human complement factor C5a antibody, in patients with ANCA-associated vasculitis. NCT03487276 Phase 2 study in Subjects With Moderate to Severe Hidradenitis Suppurativa recruiting as of July 2018. June 2018: InflaRx announced the approval of their Investigational New Drug application by the U.S. Food and Drug Administration. The open IND will allow InflaRx to start their planned Phase II study to determine the safety and efficacy of IFX-1, a first-in-class anti-human complement factor C5a antibody, in patients with ANCA-associated vasculitis (AAV Phase 2 in Severe Hidradenitis Suppurativa ongoing but not recruiting patients as of Aug 2017. EudraCT Number: 2013-001037-40 Phase 2 study lists mAb as chimeric IgG4. Phase 2 in Germany is ongoing as of Feb 2014. Follow on IFX-2 is humanized (preclin as of Feb 2014). NCT01319903 Phase 1 study completed. |
| Full address of company | Winzerlaer Str. 2, 07745 Jena Europe Germany https://www.inflarx.de/ |
Immunoglobulin G4, anti-(human complement C5a) (human-Mus musculus monoclonal IFX-1 y4-chain), disulfide with human-Mus musculus monoclonal IFX-1 k-chain, dimer
| Anticipated events | EMA positive opinion in mid-Nov 2024 - anticipate approval by late Jan 2025. |
| Factor(s) contributing to discontinuation | None |