Gohibic (vilobelimab) / Staidson Biopharma, InflaRx - LARVOL DELTA

Pyoderma gangrenosum lesions (EADV 2026) - "Rational treatment options could be escalation through 1st line therapies (topical steroids, tacrolimus, IL steroids, tetracyclines) to 2nd line therapies (prednisolone 0.5-1mg/kg/day, IV methylprednisolone, ciclosporin 4-5mg/kg/day, mycophenolate 1-3gm/day, methotrexate 15-25mg weekly, azathioprine 2-2.5mg/kg/day, dapsone, colchicine and then to 3rd line therapies (TNF inhibitors, IL-12/23 and IL-23 inhibitors, IL-17, IL-1, IL-36 and JAK inhibitors, IVIg, cyclophosphamide). C5a binding to its ligand complement component 5a receptor (C5aR) (also known as C5aR1) is not only a potent inducer of NETosis but is also a powerful chemoattractant, recruits and activates neutrophils. Avacopan (C5aR inhibitor), Vilobelimab (C5a neutralising antibody) as well as JAK inhibitors (NETosis pathway involves JAK-STAT signalling) would appear to be logical upstream inhibitors to prevent NETosis and PG and IL-36 inhibition for downstream inhibition of the cytokine storm in PG may well..."

Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Pyoderma Gangrenosum • CTSG • ELANE • IL12A • IL17A • IL23A • MPO • PRSS3

InflaRx…announced that data from the Phase 3 study of vilobelimab in pyoderma gangrenosum (PG) were featured in an oral presentation during the Late-Breaking Research abstract session at the 2026 American Academy of Dermatology (AAD) Annual Meeting… (GlobeNewswire) - "The study enrolled 54 patients prior to being terminated after an Independent Data Monitoring Committee recommended the trial be stopped early due to futility. The primary endpoint, complete target ulcer closure, was achieved by 20.8% of vilobelimab patients versus 16.7% on placebo (95% CI: -19.5%, 27.8%). Complete disease remission occurred more frequently with vilobelimab (20.8%) than placebo (5.1%) (95% CI: -4.1%, 34.7%). In addition, over one-third of vilobelimab-treated patients (36.4%) achieved more than a 50% reduction in ulcer volume compared with 16.7% of patients receiving placebo."

Late-breaking abstract • P3 data • Pyoderma Gangrenosum

Comparative Efficacy and Safety of Novel Biologics and Small-Molecule Therapies for Moderate-to-Severe Hidradenitis Suppurativa: A Systematic Review and Network Meta-Analysis (AAD 2026) - "Background Current FDA-approved systemic therapies for moderate-to-severe hidradenitis suppurativa (HS) include TNF-α inhibitors (adalimumab) and IL-17 inhibitors (bimekizumab, secukinumab) (1). Conclusions This NMA identifies JAK1 (porvocitinib, brepocitinib, and upadacitinib) and C5a (vilobelimab) inhibitors as promising investigational treatments for moderate-to-severe HS, representing potential future treatment alternatives for patients refractory to or intolerant of current therapies. However, the small-to-moderate sample sizes and short-term follow-up of such studies highlight the need for future larger, longer-term trials."

Retrospective data • Review • Dermatology • Hidradenitis Suppurativa • Immunology • IL17A • IL23A • JAK1

Vilobelimab Treatment for Ulcerative Pyoderma Gangrenosum: Results from a Multicenter, Randomized, Placebo Controlled Phase 3 Trial (AAD 2026) - No abstract available

Clinical • Late-breaking abstract • P3 data • Pyoderma Gangrenosum

InflaRx Announces Late-Breaker Oral Presentation on Vilobelimab Phase 3 Results in Pyoderma Gangrenosum at 2026 American Academy of Dermatology Annual Meeting (GlobeNewswire)

Late-breaking abstract • P3 data • Pyoderma Gangrenosum

Therapeutic Approaches to Treat SARS-CoV-2. (PubMed, ChemMedChem) - "Biological screening platforms and repurposing have resulted in the discovery of drugs such as nirmatrelvir-ritonavir (Paxlovid), remdesivir (Veklury), molnupiravir (Lagevrio), anakinra (Kineret), vilobelimab (Gohibic), baricitinib (Olumiant), and tocilizumab (Actemra). The present analysis provides details on the pathogenesis, prevention, diagnosis, clinical characteristics, and potential treatment options currently available worldwide."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

BDB-001 Phase III Trial in ANCA-Associated Vasculitis (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • ANCA Vasculitis • Vasculitis

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record) (clinicaltrials.gov) - P2 | N=600 | Recruiting | Sponsor: PPD Development, LP | Trial completion date: Feb 2028 ➔ Sep 2028 | Trial primary completion date: Nov 2027 ➔ Jul 2028

Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: PPD Development, LP | Trial completion date: Feb 2028 ➔ Sep 2028 | Trial primary completion date: Nov 2027 ➔ Jul 2028

Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma Gangrenosum (clinicaltrials.gov) - P3 | N=54 | Terminated | Sponsor: InflaRx GmbH | N=90 ➔ 54

Enrollment change • Dermatology • Pyoderma Gangrenosum

Complete Response of a Patient with Advanced Cutaneous Squamous Cell Carcinoma after Vilobelimab Monotherapy (EADV 2025) - P2 | "Introduction & Objectives: Vilobelimab is a novel targeted complement split factor C5a antibody which was tested as monotherapy and in combination with pembrolizumab in patients with PD-1 or PD-L1-resistant/refractory locally advanced or metastatic cutaneous squamous cell carcinoma (cSCC) in an open-label phase II trial... A 79-year-old female patient with locally advanced cSCC, tumor stage T2N0M0 and prognostic stage group IV and pretreated with cemiplimab, was enrolled into the study on 30-May-2022 and received 46 infusions of vilobelimab monotherapy until cycle 15, day 1 (end-of-treatment visit: 12-Feb-2024)... Vilobelimab showed promising efficacy with a 60-week overall response duration in an elderly patient with locally advanced, stage IV cSCC and a good safety profile. EADV Congress 2025, PARIS Co g ess 0 5, S 17 SEPTEMBER - 20 SEPTEMBER 2025 POWERED BY M-ANAGE.COM"

Clinical • Metastases • Monotherapy • Infectious Disease • Nephrology • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • PD-1 • PD-L1

A Targeted Blockade of Terminal C5a Is Critical to Management of Sepsis and Acute Respiratory Distress Syndrome: The Mechanism of Action of Vilobelimab. (PubMed, Int J Mol Sci) - "In January 2025, the European Commission (EC) granted marketing authorization for Gohibic® (vilobelimab) for the treatment of adult patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-induced ARDS who are receiving systemic corticosteroids as part of standard of care and receiving IMV with or without ECMO. Herein, we review the mechanism of action of vilobelimab in selectively inhibiting C5a-induced inflammation, outlining its bench-to-bedside development from the fundamental biology of the complement system and preclinical evidence through to the clinical data demonstrating its life-saving potential in the management of COVID-19-induced ARDS."

Journal • Review • Acute Respiratory Distress Syndrome • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • Septic Shock

Quality and readability of drug fact sheets for FDA-approved and emergency use authorised drug products for COVID-19 treatment: an observational study. (PubMed, BMJ Open) - "Although of fair quality, the fact sheet reading level was high, and the transparency of sources used was low. Regulatory officials should enforce readable resources from drug manufacturers to guide patients' decision-making surrounding COVID-19 therapeutics."

FDA event • Journal • Observational data • Infectious Disease • Novel Coronavirus Disease

Vilobelimab to improve clinical outcomes of moderate-to-severe hidradenitis suppurativa through an adjunctive effect on draining tunnels: Results of the SHINE double-blind, placebo-controlled randomised trial. (PubMed, Br J Dermatol) - P2 | "Vilobelimab treatment did not achieve significant HiSCR in moderate to severe HS compared to placebo. Post-hoc analysis revealed significant effects for the highest tested dose on dT reduction and IHS4 score, which captures dT reductions. These findings warrant further investigation."

Clinical data • Journal • Dermatology • Hidradenitis Suppurativa • Immunology

Dose and time dependent efficacy of vilobelimab on wound healing outcomes in patients with ulcerative pyoderma gangrenosum – findings from a Phase 2 trial (EADV 2025) - "This study provides the first evidence of dose-dependent efficacy of vilobelimab in the treatment of PG, with the 2400 mg dose showing the most pronounced and consistent improvements of the PG disease shown as complete ulcer closure and reduction of pain."

Clinical • P2 data • Inflammation • Pyoderma Gangrenosum

Vilobelimab induced C5a suppression correlates with clinical benefit and pain reduction in patients with ulcerative pyoderma gangrenosum (EADV 2025) - "The findings from this analysis demonstrate that pharmacodynamic suppression of C5a by vilobelimab is linked to clinically meaningful improvements in patients with ulcerative pyoderma gangrenosum. The increasing vilobelimab concentrations and the consequent suppression of C5a levels were correlated with wound healing, and reduction of pain. These correlations underscore a critical role of C5a in the inflammatory pathophysiology of PG and support the therapeutic potential of vilobelimab as a targeted treatment."

Clinical • Pain • Pyoderma Gangrenosum

Vilobelimab induced C5a suppression correlates with clinical benefit and pain reduction in patients with ulcerative pyoderma gangrenosum (EADV 2025) - No abstract available

Clinical • Pain • Pyoderma Gangrenosum

Dose and time dependent efficacy of vilobelimab on wound healing outcomes in patients with ulcerative pyoderma gangrenosum – findings from a Phase 2 trial (EADV 2025) - No abstract available

Clinical • P2 data • Pyoderma Gangrenosum

BDB-001 Phase III Trial in ANCA-Associated Vasculitis (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd

New P3 trial • ANCA Vasculitis • Vasculitis

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record) (clinicaltrials.gov) - P2 | N=600 | Recruiting | Sponsor: PPD Development, LP | Initiation date: Feb 2025 ➔ Jun 2025

Trial initiation date • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

Efficacy and Safety of Substitution of Glucocorticoid for BDB-001 Injection in Patients With Anti-neutrophil Cytoplasmic Antibody(ANCA)-Associated Vasculitis (clinicaltrials.gov) - P1/2 | N=93 | Completed | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | Recruiting ➔ Completed

Trial completion • ANCA Vasculitis • Vasculitis

2025 Clinical Practice Guideline Update by the Infectious Diseases Society of America on the Treatment and Management of COVID-19: Pemivibart for Pre-exposure Prophylaxis, Vilobelimab for Critical Illness, and Abatacept or Infliximab for Severe or Critical Illness. (PubMed, Clin Infect Dis) - "These recommendations include pre-exposure prophylaxis for immunocompromised persons and treatment of severe or critical COVID-19. The panel's recommendations are based upon evidence derived from systematic literature reviews and adhere to a standardized methodology for rating the certainty of evidence and strength of recommendation according to the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach."

Clinical guideline • Journal • Infectious Disease • Novel Coronavirus Disease

Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma Gangrenosum (clinicaltrials.gov) - P3 | N=90 | Terminated | Sponsor: InflaRx GmbH | Trial completion date: May 2026 ➔ Jul 2025 | Recruiting ➔ Terminated | Trial primary completion date: Feb 2026 ➔ Jul 2025; Study stopped for futility

Trial completion date • Trial primary completion date • Trial termination • Dermatology • Pyoderma Gangrenosum

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: PPD Development, LP | Initiation date: Feb 2025 ➔ Jun 2025

Trial initiation date • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

The cost-effectiveness of using vilobelimab with immunomodulators to treat severely ill mechanically ventilated patients with COVID-19: A subgroup analysis of the PANAMO study. (PubMed, Am J Health Syst Pharm) - "Vilobelimab therapy provides a cost-effective option to treat severely ill, mechanically ventilated patients with COVID-19 with prior and/or concomitant treatment with immunomodulators at a value well below the commonly accepted willingness-to-pay threshold of $50,000/QALY."

HEOR • Journal • Infectious Disease • Novel Coronavirus Disease • CFB