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

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

Treatment of Viral-induced Acute Respiratory Distress Syndrome (ARDS) With Vilobelimab: A Focus on C5a Inhibition (ATS 2025) - "Standard-of-care was corticosteroids (97%) and anticoagulant prophylaxis (98%) with ∼20% of patients receiving tocilizumab or baricitinib as part of SOC. Hospitalized and intubated COVID-19 ARDS patients have >50% mortality. 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."

Late-breaking abstract • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Treatment Effect of Vilobelimab in a Complex Patient With MRSA Pneumonia, Legionella, and Severe COVID-19 (ATS 2025) - "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."

Clinical • Addiction (Opioid and Alcohol) • Cardiovascular • CNS Disorders • Cough • Fibromyalgia • Gastrointestinal Disorder • Heart Failure • Immunology • Infectious Disease • Inflammatory Arthritis • Musculoskeletal Pain • Novel Coronavirus Disease • Obstructive Sleep Apnea • Pain • Pneumonia • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Septic Shock • Sleep Apnea • Sleep Disorder

Therapeutics controversies in antineutrophilic cytoplasmic antibody-associated vasculitis. (PubMed, Clin Exp Nephrol) - "Induction therapy has historically involved cyclophosphamide (CYC) and glucocorticoids (GCS), with rituximab (RTX) emerging as a preferred alternative...Maintenance therapy options include azathioprine, RTX, and methotrexate...Studies show that complement 3 depositions in the glomeruli correlate with severe disease and complement inhibitors such as avacopan demonstrated efficacy in the management of AAV. Other complement inhibitors, such as eculizumab and vilobelimab, are being explored. In conclusion, AAV management has made significant advances, but controversies persist. Future research should refine therapeutic regimens and explore novel targeted treatments for personalized medicine in AAV."

Journal • Review • ANCA Vasculitis • Hematological Disorders • Infectious Disease • Inflammation • Nephrology • Renal Disease • Vasculitis

2025 Clinical Practice Guideline Update by the Infectious Diseases Society of America on the Treatment and Management of COVID-19: Vilobelimab. (PubMed, Clin Infect Dis) - "The guideline panel presents a recommendation on the use of vilobelimab in hospitalized adults with critical COVID-19. The recommendation is based on evidence derived from a systematic literature review and adheres 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 • Respiratory Diseases

InflaRx Reports First Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "Interim analysis for vilobelimab Phase 3 trial in pyoderma gangrenosum (PG), to determine trial size adaptation or futility, remains on schedule with a recommendation expected to be announced at the end of May to early June; Topline data for INF904 Phase 2a trial in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) expected in summer 2025."

P2a data • P3 data • Chronic Spontaneous Urticaria • Hidradenitis Suppurativa • Pyoderma Gangrenosum

Regional comparison of efficacy and safety for vilobelimab in critically ill, invasively mechanically ventilated COVID-19 patients. (PubMed, BMJ Open Respir Res) - "The most apparent 28-day all-cause mortality benefit for vilobelimab was in western Europe. Age imbalance between treatment groups in Brazil may have resulted in a lower efficacy signal for vilobelimab in South America compared with other regions. Overall, vilobelimab demonstrated a favourable safety profile and reduced mortality in critically ill, intubated COVID-19 patients, with regional variations influencing outcomes."

Clinical • Journal • Acute Respiratory Distress Syndrome • Critical care • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases