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

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

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

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

InflaRx Receives Positive CHMP Opinion for GOHIBIC (Vilobelimab) for the Treatment of SARS-CoV-2-Induced Acute Respiratory Distress Syndrome (GlobeNewswire) - "InflaRx N.V....announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization of GOHIBIC (vilobelimab), under exceptional circumstances 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)). The Company expects the European Commission to adopt the positive opinion and issue a marketing authorization within 67 days."

CHMP • Acute Respiratory Distress Syndrome • Immunology • Novel Coronavirus Disease

An evaluation of vilobelimab (anti-C5a) as a cost-effective option to treat severely ill mechanically ventilated patients with COVID-19. (PubMed, Am J Health Syst Pharm) - "Vilobelimab provides a cost-effective option to treat ICU patients with severe COVID-19 receiving IMV compared to SOC, at well below the commonly accepted $50,000 US willingness-to-pay threshold."

Cost effectiveness • HEOR • Journal • Critical care • Infectious Disease • Novel Coronavirus Disease

VILOBELIMAB IN COMBINATION WITH TOCILIZUMAB MAY SYNERGISTICALLY IMPROVE MORTALITY IN CRITICALLY ILL COVID-19 PATIENTS: A POST-HOC ANALYSIS OF THE PHASE III PANAMO STUDY (CHEST 2024) - P2/3 | "In addition, ~20% of patients received immunomodulators, predominantly tocilizumab over baricitinib. In addition to corticosteroid and anti-thrombotic agent administration, this post-hoc analysis with a small number of patients demonstrates that the co-administration of vilobelimab with tocilizumab may have further potential to improve survival in critically ill COVID-19 patients. CLINICAL IMPLICATIONS: The co-administration of vilobelimab and tocilizumab suggests an interplay between C5a- and IL-6-induced inflammatory pathways involved in septic and ARDS COVID-19 patients. Co-administration of vilobelimab and tocilizumab may result in a synergistic survival benefit for certain critically ill ARDS patients."

Clinical • Combination therapy • P3 data • Retrospective data • Acute Respiratory Distress Syndrome • Infectious Disease • Inflammation • Novel Coronavirus Disease • Septic Shock • C5AR1 • IL6

Vilobelimab demonstrates significant improvement in reduction of draining tunnels, total lesion count, International Hidradenitis Suppurativa Score 4 and the newly introduced modified-HiSCR: a post hoc analysis of the Phase IIb SHINE study (EADV 2024) - "Draining Tunnels are indicative of severe, chronic inflammatory disease, while abscesses and nodules are acute inflammatory lesions which usually fluctuate. Based on vilobelimab ’ s mode of action in blocking C5a, vilobelimab showed reduction of the counts of all three inflammatory lesions with a significant impact on dT reduction detected, which are the lesions with the highest impact on key signs and symptoms of HS. The HiSCR50 does not count the reduction in dT, but only considers no increase in dT relative to baseline."

P2b data • Retrospective data • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation

InflaRx Presents Post Hoc Analysis of SHINE Trial of Vilobelimab in Hidradenitis Suppurativa at the 2024 European Academy of Dermatology and Venereology Congress (GlobeNewswire) - P2b | N=179 | SHINE (NCT03487276) | Sponsor: InflaRx GmbH | "InflaRx N.V...announced the e-poster presentation of a post hoc analysis of the SHINE Phase 2b study of its first-in-class anti-C5a antibody, vilobelimab, in hidradenitis suppurativa (HS) at the 2024 European Academy of Dermatology and Venereology (EADV) Congress being held in Amsterdam, September 25 – 28, 2024....In this post hoc analysis, vilobelimab 1200 mg demonstrated a placebo-adjusted significant reduction in dT, ANdT, and IHS4 of 45.2%, 25.1% and 31.6%, respectively."

P2b data • Hidradenitis Suppurativa

VILOBELIMAB IN COMBINATION WITH TOCILIZUMAB MAY SYNERGISTICALLY IMPROVE MORTALITY IN CRITICALLY ILL COVID-19 PATIENTS: A POST-HOC ANALYSIS OF THE PHASE III PANAMO STUDY (CHEST 2024) - No abstract available

Clinical • Combination therapy • P3 data • Retrospective data • Infectious Disease • Novel Coronavirus Disease

Structure of Designer Antibody-like Peptides Binding to the Human C5a with Potential to Modulate the C5a Receptor Signaling. (PubMed, J Med Chem) - "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."

Journal • Inflammation

A review on the current approaches and perspectives of Covid-19 treatment. (PubMed, Pol Merkur Lekarski) - "Currently, 11 antiviral drugs (Tixagevimab/Cilgavimab, Regdanvimab, Casirivimab/Imdevimab, Sotrovimab, Nirmatrelvir/Ritonavir, Remdesivir, Molnupiravir, Baricitinib, Anakinra, Tocilizumab, Vilobelimab) have been approved or conditionally approved by the European Medicines Agency and/or by the Food and Drug Administration and are available on the pharmaceutical market. 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."

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

KEYNOTE MK3475-PNA93: Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC. (clinicaltrials.gov) - P2 | N=25 | Terminated | Sponsor: InflaRx GmbH | 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 terminates the IFX-1-P2.8 trial due to new alternative treatments for cSCC with high efficacy rates.

Enrollment change • Metastases • Trial completion date • Trial termination • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Heterogeneity of treatment effect of vilobelimab in COVID-19: a secondary analysis of a randomised controlled trial. (PubMed, Crit Care) - P2/3 | "No signal for harm of treatment with vilobelimab was observed in any class or clinical subtype. Overall, treatment effect with vilobelimab was consistent across different classes and subtypes, except for the δ subtype, suggesting potential additional benefit for the most severely ill patients."

Clinical • Heterogeneity • Journal • Immunology • Infectious Disease • Novel Coronavirus Disease • Septic Shock

Treatment of Pyoderma Gangrenosum With Vilobelimab. (PubMed, JAMA Dermatol) - No abstract available

Journal • Pyoderma Gangrenosum

Vilobelimab in Combination With Tocilizumab or Baricitinib Dramatically Improves Mortality in Critically Ill COVID-19 Patients: A Subgroup Analysis (ATS 2024) - "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."

Clinical • Combination therapy • Late-breaking abstract • Infectious Disease • Novel Coronavirus Disease • CFB

Bayer HealthCare Products Included in Breakthrough Therapy Program [Google translation] (Sina Corp) - "On June 8, according to the official website of CDE, the drug 'BAY 2927088 Solution' jointly applied for by Bayer HealthCare Co., Ltd. has been reviewed and agreed to be included in the breakthrough therapy drug program, and the public announcement deadline is June 8, 2024....The detailed information disclosed in the announcement shows that the drug type of 'BDB-001 Injection' is a chemical drug, and the proposed indications (or main functions) are: BAY 2927088 is suitable for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) who carry HER2 (ERBB2) activating mutations and have previously received a systemic treatment."

Breakthrough therapy • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

Efficacy and Safety Study of BDB-001 in Severe COVID-19 With ALI/ARDS (clinicaltrials.gov) - P2/3 | N=369 | Terminated | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | Active, not recruiting ➔ Terminated; Due to the COVID-19 epidemic situation, the sponsor has decided to terminate the project.

Trial termination • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

InflaRx Presents New Analysis of PANAMO Phase III Trial in Severe COVID-19 at ATS 2024 Showing Potential Synergy With Vilobelimab When Used in Combination with Other Immunomodulators (GlobeNewswire) - P2/3 | N=399 | PANAMO (NCT04333420) | Sponsor: InflaRx GmbH | "The analysis presented at ATS 2024 is comprised of 71 patients from PANAMO that assessed 28- and 60-day all-cause mortality in the subgroup of patients taking the combination of vilobelimab plus tocilizumab or baricitinib versus patients on placebo plus tocilizumab or baricitinib....The point estimate for 28-day all-cause mortality was 6.3% in the vilobelimab plus tocilizumab or baricitinib arm, and 40.9% in the placebo plus tocilizumab or baricitinib arm: this is a significant relative reduction of 84.6% (HR 0.13; 95% CI:0.03-0.56, p=0.006) between the two arms. Day 60 all-cause mortality was 16.4% and 49.3%, respectively (HR 0.25; 95% CI:0.09-0.68, p=0.006), a significant relative reduction."

P3 data • Novel Coronavirus Disease • Pneumonia

A Safety and Tolerability Study of BDB-001 in Mild, Moderate COVID-19 Patients (clinicaltrials.gov) - P1 | N=18 | Terminated | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | Completed ➔ Terminated; Due to the COVID-19 epidemic situation, the sponsor has decided to terminate the project.

Trial termination • Infectious Disease • Novel Coronavirus Disease

KEYNOTE MK3475-PNA93: Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC. (clinicaltrials.gov) - P2 | N=70 | Active, not recruiting | Sponsor: InflaRx GmbH | Trial primary completion date: Mar 2024 ➔ Jun 2024

Metastases • Trial primary completion date • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Comparative efficacy and therapeutic positioning of biologics in hidradenitis suppurativa: A systematic review with network meta-analysis of randomised trials. (PubMed, Indian J Dermatol Venereol Leprol) - "The NMA showed the odds of achieving the clinical response were significantly superior with adalimumab (RR: 0.37, 95% CI = 0.06-0.63), adalimumab QW (RR: 0.63, 95% CI = 0.43-0.87), MAB1p (RR: 1.33, 95% CI = 0.03-3.12), secukinumab (RR: 0.25, 95% CI = 0.11-0.47) and secukinumabQ2W (RR: 0.24, 95% CI = 0.1-0.46) compared to placebo...Data for bimekizumab and CJM112 are promising. Infliximab has inconsistent clinical response, and more data are necessary to confirm this molecule as a potential third-line therapy in HS. 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."

Journal • Retrospective data • Review • Dermatology • Hidradenitis Suppurativa • Immunology • Oncology • IL23A

Choosing immunomodulating therapies for the treatment of COVID-19: Recommendations based on placebo-controlled trial evidence. (PubMed, Clin Microbiol Infect) - "Placebo-controlled trial evidence indicates that baricitinib should be the first choice immunomodulator for patients hospitalized for COVID-19 who require any form of oxygen support-low or high-flow oxygen, non-invasive or invasive ventilation. Vilobelimab warrants study in a large placebo-controlled trial. Treatment guidelines for future pandemics should prioritize the results of placebo-controlled trials."

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

Efficacy and Safety Study of BDB-001 in Severe COVID-19 With ALI/ARDS (clinicaltrials.gov) - P2/3 | N=368 | Active, not recruiting | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2022 ➔ May 2024 | Trial primary completion date: Jan 2022 ➔ May 2024

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Pneumonia

Rational design of antibody-like peptides for targeting the human complement fragment protein C5a. (PubMed, Proteins) - "Indeed, antibodies targeting C5 (Eculizumab), the precursor of C5a, and C5a (Vilobelimab) have already been approved by the FDA. 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."

Journal • Inflammation

Outcomes of COVID-19 Infection in Patients with ANCA-Associated Vasculitis Receiving Avacopan Therapy (KIDNEY WEEK 2023) - "Vilobelimab, a C5a antibody was granted Emergency Use Authorization by the FDA for severe COVID-19 infection...Five patients received a combination of rituximab, cyclophosphamide, glucocorticoids, and avacopan, whereas 2 patients received rituximab, glucocorticoids, and avacopan...COVID-19 treatment included Paxlovid (n=3), Bebtelovimab (n=1), Molnupiravir (n=1), remdesivir and dexamethasone (n=1), and no treatment (n=1). COVID-19 clinical course appears to be mild in the majority AAV patients treated with avacopan, with a single patient experiencing severe COVID-19 infection and death. More studies are needed to explore the interplay between C5a blockade and infectious complications from SARS-CoV-2."

Clinical • ANCA Vasculitis • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Vasculitis

InflaRx Announces First Patient Dosed in Phase III Trial with Vilobelimab in Pyoderma Gangrenosum (GlobeNewswire) - "InflaRx N.V...announced today that the first patient has been dosed in its Phase III study investigating the efficacy and safety of vilobelimab in ulcerative PG, a rare neutrophilic and inflammatory skin disease characterized by destructive, painful cutaneous ulcers."

Trial status • Immunology • Pyoderma Gangrenosum