Gohibic (vilobelimab) / Staidson Biopharma, InflaRx 
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 8 Diseases   6 Trials   6 Trials   84 News 


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  • ||||||||||  Gohibic (vilobelimab) / Staidson Biopharma, InflaRx
    Treatment of Viral-induced Acute Respiratory Distress Syndrome (ARDS) With Vilobelimab: A Focus on C5a Inhibition (Room 24, Hall E (North Building, Exhibition Level), Moscone Center) -  Mar 16, 2025 - Abstract #ATS2025ATS_9455;    
    Vilobelimab, by blocking C5a, inhibiting neutrophil activation and disrupting the inflammatory cascade demonstrated improved survival among COVID-19 ARDS patients. Other respiratory viruses are known to induce C5a as part of their pathophysiology causing ARDS.
  • ||||||||||  Gohibic (vilobelimab) / Staidson Biopharma, InflaRx
    Treatment Effect of Vilobelimab in a Complex Patient With MRSA Pneumonia, Legionella, and Severe COVID-19 (Area K, Hall F (North Building, Exhibition Level), Moscone Center; Poster Board # P1331) -  Feb 24, 2025 - Abstract #ATS2025ATS_4594;    
    Dexamethasone and oxygenation including IMV or ECMO are standard-of-care...Patient was administered IV antibiotics (VA/MEM/MTZ/CTX/CPM/AZI/DOXY/LEVO) with de-escalation to only vancomycin/levofloxacin by day 6, remdesivir (Day 1-5) and IV vilobelimab 800mg on Days 1,2,4,8,15.On Day 5, patient was extubated... In this complex septic pneumonia patient with triple positive diagnostic findings of independently difficult to treat infections, vilobelimab therapy was associated with clearing of the pneumonia and improvement of oxygenation/lung function leading to discharge of the patient from the ICU.
  • ||||||||||  Gohibic (vilobelimab) / Staidson Biopharma, InflaRx
    Vilobelimab Safety in Pyoderma Gangrenosum Patients: A Phase 2a Explorative Dose-Finding Study (Orange County Convention Center (West Building, Exhibit Hall B4, Poster Center 1)) -  Feb 21, 2025 - Abstract #AAD2025AAD_3068;    
    Vilobelimab was well-tolerated across all three groups. There was no specific safety concerns associated with vilobelimab treatment in the three dose groups and no dose relationship was observed.
  • ||||||||||  Gohibic (vilobelimab) / Staidson Biopharma, InflaRx
    Vilobelimab Post-hoc Efficacy in Hidradenitis Suppurativa using the Modified-HiSCR with Data from the Phase 2b SHINE Study () -  Feb 21, 2025 - Abstract #AAD2025AAD_3041;    
    Since inflammatory dT in HS patients greatly affects quality of life sometimes requiring invasive surgery, the m-HiSCR represents a promising endpoint to assess therapeutic interventions in more severe HS patients. The outcome using m-HiSCR for vilobelimab versus placebo suggests that this C5a inhibitor may be an effective therapy for HS, especially in patients with more severe disease.
  • ||||||||||  Gohibic (vilobelimab) / Staidson Biopharma, InflaRx
    Journal:  Treatment of Pyoderma Gangrenosum With Vilobelimab. (Pubmed Central) -  Aug 21, 2024   
    Co-administration of vilobelimab and tocilizumab may result in a synergistic survival benefit for certain critically ill ARDS patients. No abstract available
  • ||||||||||  Soliris (eculizumab) / AstraZeneca, Gohibic (vilobelimab) / Staidson Biopharma, InflaRx
    Journal:  Structure of Designer Antibody-like Peptides Binding to the Human C5a with Potential to Modulate the C5a Receptor Signaling. (Pubmed Central) -  Jul 26, 2024   
    Notably, the FDA has already approved antibodies that target the precursors of C5a (Eculizumab, 148 kDa) and C5a (Vilobelimab, 149 kDa) for marketing as complement-targeted therapeutics. In this context, the current study reports the structural characterization of a pair of synthetic designer antibody-like peptides (DePA and DePA1; ?3.8 kDa) that bind to hotspot regions on C5a and also demonstrates potential traits to neutralize the function of C5a under pathophysiological conditions.
  • ||||||||||  Review, Journal:  A review on the current approaches and perspectives of Covid-19 treatment. (Pubmed Central) -  Jul 15, 2024   
    The article brief l y describes the current epidemiological situation regarding COVID-19 and the currently used vaccines. Moreover, the paper outlines currently used and researched potential drugs in the pharmacotherapy of this disease.
  • ||||||||||  Gohibic (vilobelimab) / Staidson Biopharma, InflaRx
    Enrollment change, Trial completion date, Trial termination:  KEYNOTE MK3475-PNA93: Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC. (clinicaltrials.gov) -  Jun 30, 2024   
    P2,  N=25, Terminated, 
    Moreover, the paper outlines currently used and researched potential drugs in the pharmacotherapy of this disease. N=70 --> 25 | Trial completion date: Dec 2024 --> Jun 2024 | Active, not recruiting --> Terminated; Sponsor decided to stop the development of vilobelimab in cSCC and early terminated the IFX-1-P2.8 trial due to new alternative treatments for cSCC with high efficacy rates.
  • ||||||||||  Gohibic (vilobelimab) / Staidson Biopharma, InflaRx
    Trial termination:  Efficacy and Safety Study of BDB-001 in Severe COVID-19 With ALI/ARDS (clinicaltrials.gov) -  May 22, 2024   
    P2/3,  N=369, Terminated, 
    subtype, suggesting potential additional benefit for the most severely ill patients. Active, not recruiting --> Terminated; Due to the COVID-19 epidemic situation, the sponsor has decided to terminate the project.
  • ||||||||||  Gohibic (vilobelimab) / Staidson Biopharma, InflaRx
    Trial termination:  A Safety and Tolerability Study of BDB-001 in Mild, Moderate COVID-19 Patients (clinicaltrials.gov) -  May 20, 2024   
    P1,  N=18, Terminated, 
    Active, not recruiting --> Terminated; Due to the COVID-19 epidemic situation, the sponsor has decided to terminate the project. Completed --> Terminated; Due to the COVID-19 epidemic situation, the sponsor has decided to terminate the project.
  • ||||||||||  Olumiant (baricitinib) / Eli Lilly, Actemra IV (tocilizumab) / Roche, JW Pharma, Gohibic (vilobelimab) / Staidson Biopharma, InflaRx
    Vilobelimab in Combination With Tocilizumab or Baricitinib Dramatically Improves Mortality in Critically Ill COVID-19 Patients: A Subgroup Analysis (San Diego Convention Center, Area K (Hall H, Ground Level)) -  Mar 17, 2024 - Abstract #ATS2024ATS_9418;    
    The blockade of IL-23 and CD5a pathways is not relevant, or at least the current evidence is insufficient to recommend further investigation of guselkumab, risankizumab, and vilobelimab in phase III trials. In addition to corticosteroid and anti-thrombotic agent administration, this post-hoc analysis with a small number of patients suggests that the co-administration of vilobelimab with baricitinib or tocilizumab may have further potential to improve survival in critically ill COVID-19 patients.
  • ||||||||||  Gohibic (vilobelimab) / Staidson Biopharma, InflaRx
    Enrollment closed, Trial completion date, Trial primary completion date:  Efficacy and Safety Study of BDB-001 in Severe COVID-19 With ALI/ARDS (clinicaltrials.gov) -  Dec 29, 2023   
    P2/3,  N=368, Active, not recruiting, 
    In addition to corticosteroid and anti-thrombotic agent administration, this post-hoc analysis with a small number of patients suggests that the co-administration of vilobelimab with baricitinib or tocilizumab may have further potential to improve survival in critically ill COVID-19 patients. Recruiting --> Active, not recruiting | Trial completion date: Aug 2022 --> May 2024 | Trial primary completion date: Jan 2022 --> May 2024
  • ||||||||||  Gohibic (vilobelimab) / Staidson Biopharma, InflaRx
    Journal:  Targeting C5a is beneficial in critically ill COVID-19 patients. (Pubmed Central) -  Dec 17, 2023   
    Recruiting --> Active, not recruiting | Trial completion date: Aug 2022 --> May 2024 | Trial primary completion date: Jan 2022 --> May 2024 No abstract available
  • ||||||||||  Soliris (eculizumab) / AstraZeneca, Gohibic (vilobelimab) / Staidson Biopharma, InflaRx
    Journal:  Rational design of antibody-like peptides for targeting the human complement fragment protein C5a. (Pubmed Central) -  Nov 7, 2023   
    The computational data further supports the potential of designer peptides for mimicking the function of antibodies targeting C5a. However, further experimental studies will be required to establish the structure-function relationship of the designer peptides and also to establish the hypothesis of antibody-like peptides targeting C5a.
  • ||||||||||  Gohibic (vilobelimab) / Staidson Biopharma, InflaRx
    Journal:  Optimizing the use of vilobelimab for the treatment of COVID-19. (Pubmed Central) -  Jul 8, 2023   
    A pragmatic, adaptive, randomized, multicenter phase II/III study evaluating vilobelimab for the treatment of severe COVID-19 found that patients receiving invasive mechanical ventilation and usual care who were treated with vilobelimab had a lower risk of death by day 28 and day 60 compared to those receiving placebo. This manuscript explores what is known about vilobelimab and explores how this treatment may be used in the future to treat severe COVID-19.
  • ||||||||||  Gohibic (vilobelimab) / Staidson Biopharma, InflaRx
    Vilobelimab (Yellow 1+2+3) -  Jun 17, 2023 - Abstract #ERS2023ERS_779;    
    Recruiting --> Completed Respiratory intensive care; Physiology; Cell and molecular biology