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

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

InflaRx to Showcase Vilobelimab’s Role in Immuno-Dermatology at the 2025 AAD Annual Meeting (GlobeNewswire) - "InflaRx N.V...today announced acceptance of all submitted abstracts, featuring the role of vilobelimab in pyoderma gangrenosum (PG) and hidradenitis suppurativa (HS), to be presented during the 2025 American Academy of Dermatology (AAD) Annual Meeting, March 7 - 11, in Orlando, FL."

P2 data • Hidradenitis Suppurativa • Pyoderma Gangrenosum

InflaRx Reports Full Year 2024 Results and Highlights Key Achievements and Expected Milestones (GlobeNewswire) - "INF904 in CSU and HS : Topline data from this study are expected in the summer of 2025, with a goal of informing the planning and design of a larger, longer-term Phase 2b study by year-end 2025....Vilobelimab in PG : Pivotal Phase 3 trial interim analysis expected by the end of May 2025....GOHIBIC (vilobelimab): In January 2025, the European Commission (EC) granted marketing authorization under exceptional circumstances for GOHIBIC (vilobelimab) for the treatment of adult patients with SARS-CoV-2-induced ARDS..."

EMA approval • P2b data • P3 data • Acute Respiratory Distress Syndrome • Chronic Spontaneous Urticaria • Hidradenitis Suppurativa • Pyoderma Gangrenosum

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record) (clinicaltrials.gov) - P2 | N=600 | Recruiting | Sponsor: PPD DEVELOPMENT, LP | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

Vilobelimab Safety in Pyoderma Gangrenosum Patients: A Phase 2a Explorative Dose-Finding Study (AAD 2025) - "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."

Clinical • P2a data • Dermatology • Hematological Disorders • Infectious Disease • Inflammation • Pain • Pyoderma Gangrenosum

Pharmacokinetic/Pharmacodynamic Analysis of Vilobelimab and Complement C3 and C5a in a Randomized, Controlled Multidose Phase 2a Study in Pyoderma Gangrenosum (AAD 2025) - "This PK/PD analysis suggests doses >1600mg given bi-weekly of vilobelimab are needed in severe PG patients to suppress C5a."

Clinical • P2a data • PK/PD data • Dermatology • Pain • Pyoderma Gangrenosum

Vilobelimab Safety in Hidradenitis Suppurativa Patients in a Randomized, Placebo-Controlled, Double-Blind Multicenter Phase 2b study (AAD 2025) - P2 | "Vilobelimab was well-tolerated in this study with a similar frequency, severity and pattern of AEs observed at all doses compared to placebo."

Clinical • P2b data • Dermatology • Hidradenitis Suppurativa • Immunology

Vilobelimab Post-hoc Efficacy in Hidradenitis Suppurativa using the Modified-HiSCR with Data from the Phase 2b SHINE Study (AAD 2025) - "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."

Clinical • P2b data • Retrospective data • Dermatology • Hidradenitis Suppurativa • Immunology • Pain

Reduction in Draining Tunnels in Hidradenitis Suppurativa Patients Treated with Vilobelimab in a Randomized, Placebo-Controlled, Double-Blind Multicenter Phase 2b Study (AAD 2025) - P2 | "dTs have the greatest impact on QoL in HS patients. These results show that vilobelimab successfully reduces the number of dTs with greatest effect achieved with the dose 1200mg Q2W."

Clinical • P2b data • Dermatology • Hidradenitis Suppurativa • Immunology

Pharmacokinetic/Pharmacodynamic Analysis of Vilobelimab Demonstrates a Significant Reduction of C5a Levels in Hidradenitis Suppurativa Patients (AAD 2025) - P2 | "The administration of 800mg vilobelimab resulted in trough levels which significantly reduced C5a concentrations but had no effect on C3a suggesting that only terminal complement fragment C5a was inhibited."

Clinical • PK/PD data • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation

Vilobelimab in PG at AAD 2025 (GlobeNewswire) - P2a | N=19 | NCT03971643 | Sponsor: InflaRx GmbH | "In an oral poster session...the Company presented safety data, showing that adverse events (AEs) were mostly mild to moderate...In addition, no clinically relevant findings for vital signs, ECGs, hematology, clinical chemistries or urinalysis were seen. In an ePoster...InflaRx presented PK/PD data in PG measuring relative changes in C5a concentrations from baseline in three vilobelimab dose groups. C5a decreased from baseline throughout the study, with an approximate 90% reduction observed by Day 15 in all dose groups and sustained in Group 2 (1600 mg bi-weekly) and Group 3 (2400 mg bi-weekly) out to Day 99. The PK/PD analysis also suggested that doses greater than 1600mg given bi-weekly of vilobelimab are needed in ulcerative PG patients to suppress C5a."

P2a data • Pyoderma Gangrenosum

Vilobelimab in HS at AAD 2025 (GlobeNewswire) - P2b | N=179 | SHINE (NCT03487276) | Sponsor: InflaRx GmbH | "A post-hoc analysis...assessed the impact of vilobelimab on reducing dT, which are a tremendous burden on patients and sometimes require invasive surgery. Vilobelimab showed a significantly greater reduction in mean dT count versus placebo of -63.2% versus -18.0%. Vilobelimab demonstrated a significantly higher rate of complete resolution of dT (dT100) versus placebo of 40.9% versus 13.0%, for a 3.1x relative responder improvement in favor of vilobelimab. Additional data presented from SHINE included a safety analysis...which showed that vilobelimab was well tolerated with a similar frequency, severity and pattern of AEs observed at all doses compared to placebo...Featured in an ePoster...a PK/PD analysis showed that the administration of 800mg vilobelimab resulted in trough levels which significantly reduced C5a concentrations from Day 1."

P2b data • Hidradenitis Suppurativa

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: PPD DEVELOPMENT, LP | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

VILOBELIMAB WITH BASELINE VASOPRESSOR USE IMPROVES MORTALITY IN CRITICALLY ILL COVID-19 PATIENTS (SCCM 2025) - P2/3 | "Treatment with vilobelimab with baseline vasopressor use led to significantly improved survival compared to placebo with baseline vasopressors in critically ill COVID-19 patients. These results warrant further study of vilobelimab in septic patients with baseline vasopressor use."

Clinical • Infectious Disease • Novel Coronavirus Disease • Septic Shock

InflaRx Announces Closing of $30 Million Public Offering of Ordinary Shares and Pre-Funded Warrants (GlobeNewswire) - "InflaRx...announced today that it has completed its underwritten public offering of 8,250,000 ordinary shares of the Company at a public offering price of $2.00 per ordinary share and in lieu of ordinary shares to certain investors, pre-funded warrants to purchase up to 6,750,000 of the Company’s ordinary shares....The aggregate gross proceeds from the offering were approximately $30 million, before deducting the underwriting discount and offering expenses....The Company intends to use the net proceeds from the offering primarily to fund clinical development of its pipeline candidates, including vilobelimab and INF904, and for general corporate purposes."

Commercial • Immunology • Inflammation

InflaRx Announces Pricing of $30 Million Public Offering of Ordinary Shares and Pre-Funded Warrants (GlobeNewswire) - "InflaRx N.V...announced today the pricing of its underwritten public offering of 8,250,000 ordinary shares of the Company at an offering price of $2.00 per ordinary share and in lieu of ordinary shares to certain investors, pre-funded warrants to purchase up to 6,750,000 of the Company’s ordinary shares. The purchase price of each pre-funded warrant is equal to the price per share at which ordinary shares are being sold to the public in this offering, minus $0.001, which is the exercise price of each pre-funded warrant...The offering is expected to close on February 18, 2025, subject to the satisfaction of customary closing conditions...The Company intends to use the net proceeds from the offering primarily to fund clinical development of its pipeline candidates, including vilobelimab and INF904, and for general corporate purposes."

Financing • Immunology • Inflammation

InflaRx Receives European Commission Approval for GOHIBIC (vilobelimab) for the Treatment of SARS-CoV-2-Induced Acute Respiratory Distress Syndrome (ARDS) (GlobeNewswire) - "InflaRx N.V...announced that the European Commission (EC) has granted marketing authorization under exceptional circumstances for GOHIBIC (vilobelimab) 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). GOHIBIC is the first and only treatment approved in the European Union for the treatment of SARS-CoV-2-induced ARDS....The EU approval of GOHIBIC 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."

EMA approval • Acute Respiratory Distress Syndrome

Updates in innovation of the treatment of pyoderma gangrenosum. (PubMed, Expert Rev Clin Pharmacol) - "New therapeutics such as interleukin 36 inhibitor and complement component C5a inhibitor more specifically target key pathways in the pathogenesis of PG have shown promise and can greatly benefit patients with PG, which still lacks an FDA-approved treatment. In addition to systemic therapy, local wound care and pain management should be carried out simultaneously to achieve successful wound healing."

Journal • Review • Dermatology • Pain • Pyoderma Gangrenosum

Limitation of site-stratified cox regression analysis in survival data: a cautionary tale of the PANAMO phase III randomized, controlled study in critically ill COVID-19 patients. (PubMed, Trials) - "Other analyses utilizing no or different stratification (e.g., stratifying by country, region, pooling low enrollment clinical sites) evaluates 100% of patient data resulting in p-values suggesting a positive treatment effect (p < 0.05). We demonstrate how this technical artifact occurs by adjustment for site stratification within the Cox regression analysis for survival outcomes and how alternative stratification corrects this discrepancy."

Clinical • Journal • P3 data • Infectious Disease • Novel Coronavirus Disease

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record) (clinicaltrials.gov) - P2 | N=600 | Not yet recruiting | Sponsor: PPD DEVELOPMENT, LP

New P2 trial • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases