RegulationFast Track (United States), Emergency Use Authorization (United States), Orphan Drug (United States), Orphan Drug (European Union), Exceptional Circumstances (European Union)

Structure/Sequence

Sequence Code 616722016H

Source: *****

Sequence Code 616722017L

Source: *****

Clinical Trials associated with Vilobelimab

NCT06701682

/ RecruitingPhase 2

Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)

This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design.
Cohort A: Participants will be randomized to receive either a placebo or vilobelimab.
This record describes the default procedures and analyses for Cohort A. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.

Start Date21 Jun 2025

Sponsor / Collaborator

PPD Development LP

[+4]

NCT06703073

/ RecruitingPhase 2

Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)

This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design. Participants will be randomized to receive either a placebo or one of the active treatments.
This record describes the default procedures and analyses for all cohorts. Each specific cohort may have additional eligibility requirements, safety and efficacy procedures, or endpoints, which will be described in the corresponding intervention-specific records on clinicaltrials.gov listed below in the detailed description.

Start Date10 Jun 2025

Sponsor / Collaborator

PPD Development LP

[+4]

NCT05964413

/ TerminatedPhase 3

A Randomized, Double-blind, Placebo-controlled, Multicenter, Adaptive Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in the Treatment of Ulcerative Pyoderma Gangrenosum

A randomized, double-blind, placebo-controlled, multicenter, adaptive phase III trial to investigate efficacy and safety of vilobelimab in the treatment of ulcerative pyoderma gangrenosum

Start Date01 Nov 2023

Sponsor / Collaborator

InflaRx GmbH

100 Clinical Results associated with Vilobelimab

100 Translational Medicine associated with Vilobelimab

100 Patents (Medical) associated with Vilobelimab

Literatures (Medical) associated with Vilobelimab

27 Jan 2026·AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY

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

Article

Author: Seheult, Roger ; Oderda, Gary ; Biskupiak, Joseph ; Burnett, Bruce P ; Brixner, Diana ; Malone, Daniel C

Abstract:

Purpose:

The anti–C5a complement factor blocker vilobelimab (Gohibic) is authorized for emergency use by the US Food and Drug Administration for the treatment of hospitalized adults with COVID-19 when initiated within 48 hours of starting invasive mechanical ventilation or extracorporeal membrane oxygenation. In the PANAMO phase 3 trial of vilobelimab vs standard of care (SoC) (corticosteroids and antithrombotic agents), a post hoc analysis showed that prior and/or concomitant treatment with immunomodulators (tocilizumab or baricitinib) provided additional survival benefit with vilobelimab (n = 34) but not with SoC (n = 37). The point estimate for 28-day all-cause mortality for these groups was 6.3% vs 40.9% (hazard ratio, 0.13; 95% confidence interval, 0.03-0.56; P = 0.006). The current analysis evaluated the cost-effectiveness of vilobelimab vs SoC for the subgroup in the PANAMO study receiving immunomodulators.

Methods:

A short-term acute care decision tree followed by a postdischarge 2-state Markov cohort model was used to estimate quality-adjusted life years (QALYs) and the incremental cost-effectiveness ratio (ICER) of the treatment arms. The model simulated progression from severe COVID-19 to survival or death over a lifetime. Outcomes data (COVID-19 all-cause mortality) were incorporated from PANAMO. Posthospitalization mortality was based on CDC age-specific survival data. Utility values and hospital costs came from the literature, and the cost of vilobelimab was obtained from Red Book online.

Results:

The total cost of care was $103,414 with SoC and $132,247 with vilobelimab, with an incremental cost of $28,833. SoC provided 6.05 QALYs vs 9.71 QALYs for vilobelimab (3.65 additional QALYs). The ICER for vilobelimab compared to SoC, both with immunomodulators, was $7,892/QALY. Probabilistic sensitivity analysis demonstrated the robustness of the cost-effectiveness result, as vilobelimab + SoC was favored at a willingness-to-pay threshold of $50,000/QALY in over 98% of iterations.

Conclusion:

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.

27 Jan 2026·BRITISH JOURNAL OF DERMATOLOGY

Vilobelimab to improve clinical outcomes in moderate-to-severe hidradenitis suppurativa through an adjunctive effect on draining tunnels: results of the SHINE double-blind placebo-controlled randomized trial

Article

Author: Anadkat, Milan J ; Becherel, Pierre-André ; Kanni, Theodora ; Gooderham, Melinda ; Papakonstantis, Markos ; Prens, Errol P ; Breno, Brigitte ; Giamarellos-Bourboulis, Evangelos J ; Szepietowski, Jacek C ; Kantardjiev, Vessel ; Weisman, Jamie ; Berneman, Debra ; Jemec, Gregor B E ; Nowicki, Roman J ; Pinter, Andreas ; van der Zee, Hessel H ; Otto, Isabell ; Alavi, Afsaneh ; Thomsen, Simon Francis ; Sayed, Christopher J ; Riedemann, Niels C ; Stone, Melody ; Pulka, Grazyna ; Katoulis, Alexandros ; Zouboulis, Christos C

Abstract:

Background:

The results of a previous phase IIa trial suggested efficacy of the anti-C5a compound vilobelimab in a small number of patients with severe hidradenitis suppurativa (HS) refractory to adalimumab treatment.

Objectives:

To study the efficacy of vilobelimab in a larger-scale randomized phase IIb trial (SHINE) of patients with moderate-to-severe HS.

Methods:

In total, 177 patients with moderate-to-severe HS were treated either with placebo or one of four doses of vilobelimab, a monoclonal antibody that targets the complement split product C5a. Hidradenitis Suppurativa Clinical Response (HiSCR) at 16 weeks was the primary endpoint. Those who achieved HiSCR switched to open-label low-dose vilobelimab; those who did not were switched to medium-dose vilobelimab. The trial was registered with the EU Clinical Trials Register (EudraCT number 2017-004501-40) and ClinicalTrials.gov (NCT03487276).

Results:

The study did not meet the primary endpoint, perhaps due, in part, to an unexpectedly high HiSCR placebo response rate of 47.1%. HS flares decreased and post hoc analysis showed that high-dose vilobelimab significantly decreased the median draining tunnel counts and IHS4 score by 63%. Following the switch to medium-dose vilobelimab at week 16, 45.5% of those who did not respond to treatment achieved HiSCR at week 40.

Conclusions:

Compared with placebo, vilobelimab treatment did not result in significant HiSCR improvements in patients with moderate-to-severe HS. Post hoc analysis revealed significant effects for the highest tested dose on draining tunnel reduction and IHS4 score, which captures reductions in draining tunnels. These findings warrant further investigation.

16 Jan 2026·CLINICAL INFECTIOUS DISEASES

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

Review

Author: Chiotos, Kathleen ; Loveless, Jennifer ; Glidden, David V ; Johnson, Steven ; Gandhi, Rajesh T ; Baden, Lindsey R ; Bedimo, Roger ; Falck-Ytter, Yngve ; Dzierba, Amy L ; Nadig, Nandita ; Martin, Greg S ; Tebas, Pablo ; Bhimraj, Adarsh ; Pearson, Jeffrey C ; MacBrayne, Christine ; Shumaker, Amy Hirsch ; Morgan, Rebecca L ; Li, Jonathan Z ; Riley, Laura ; Shoham, Shmuel ; Cawcutt, Kelly ; Cheng, Vincent Chi-Chung ; Hardy, Erica J ; Daar, Eric S ; Kim, Arthur Y ; Nakamura, Mari M ; Chew, Kara W ; Shafer, Robert W ; Tien, Phyllis C

Abstract:

As the first part of several focused updates to the clinical practice guideline on the treatment and management of COVID-19 in adults, children, and pregnant people, developed by the Infectious Diseases Society of America, the panel presents four new recommendations. 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.

116

News (Medical) associated with Vilobelimab

11 Jan 2026

·www.globenewswire.com

InflaRx Announces Strategy Focused on Capital-Efficient Execution with Izicopan and Near-Term Value Creation

InflaRx to prioritize izicopan as its leading pipeline asset, with a goal of continuing toward Phase 2b readiness in hidradenitis suppurativa (HS) To broaden signal-finding activities for izicopan in additional I&I (inflammation and immunology) indications, InflaRx intends to conduct a PK bridging study in China in 2026 to enable expedited proof of concept studies in China and additional geographies Toward the goal of fast-tracking izicopan development across all applicable I&I indications, InflaRx continues its concurrent strategy to foster discussions with potential collaborators InflaRx is executing an approximately 30% workforce reduction, leading to a significant reduction of the Company’s cost structure, and extension of its cash runway to mid-2027 The Company intends to host a virtual Capital Markets Day to highlight the clinical utility and commercial potential of izicopan in HS and I&I broadly in spring 2026 Jan. 08, 2026 -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced it is undertaking measures to reduce spending, extend the Company’s cash runway, and align resources to enable further development of izicopan in HS and other I&I indications as a potential best-in-class C5aR inhibitor and pipeline-in-a-product. Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: “In an effort to enable the long-term success of InflaRx we have made the decision to increase our capital efficiency and tightly focus the Company. Our goal with this realignment is to prioritize resources toward izicopan in hidradenitis suppurativa and additional areas in inflammation and immunology, allowing us to maximize its value as a significantly differentiated oral inhibitor of C5aR and pipeline-in-a-product. We are very optimistic about our strategy and the sizable potential of izicopan, and look forward to reporting additional progress during the year.” As part of its strategic focusing, InflaRx is streamlining its organizational structure and largely discontinuing non-essential activities outside the development of izicopan. These actions are designed to sharpen the Company’s strategic execution, concentrate resources on its highest-value asset, and materially improve capital efficiency. InflaRx has initiated a workforce reduction of approximately 30% and substantial spending reductions, including significant reductions in Gohibic (vilobelimab) commercial spending and related functions. The Company estimates these activities will result in a one-time charge of approximately $7 million. The majority of this charge will be a non-cash charge related to the write-off of vilobelimab inventory, with a smaller portion associated with the restructuring, including personnel-related costs and the termination or modification of certain third-party contracts. Upon completion, InflaRx expects a significantly leaner cost structure, enabling substantial and sustained reductions in operating expenses and a meaningful extension of its cash runway to mid-2027. InflaRx will maintain the operational capability needed to support the ongoing BARDA “Just Breathe” Phase 2 clinical platform study in ARDS and does not expect these actions to negatively impact the trial. InflaRx will keep Gohibic (vilobelimab) available for ordering inside the US under its emergency use authorization and maintain the ability to satisfy Gohibic (vilobelimab) demand in the US on a reactive basis. InflaRx will continue to review partnering opportunities for Gohibic in the US and Europe. In addition, as previously disclosed, the Company anticipates meeting with the FDA to determine a potential development path forward for vilobelimab in pyoderma gangrenosum, which it anticipates would only be conducted in collaboration with a partner. Given data demonstrating its advantageous PK/PD profile, meaningful differentiation as an inhibitor of the C5a/C5aR axis, and potential to address HS, chronic spontaneous urticaria (CSU) and other I&I indications, the Company will prioritize resource allocation and clinical development toward izicopan while continuing active dialog with potential partners across all geographies to expedite and maximize value. In HS InflaRx continues to make progress toward Phase 2b readiness. InflaRx is in active dialogue with the FDA related to the Phase 2b study design and potential endpoints. The aim is to align on a development path and endpoints expected to meaningfully differentiate izicopan from existing therapies, while also addressing variability inherent in some HS trial outcomes. InflaRx is moving as quickly as is feasible in this effort and intends to provide an update on its HS Phase 2b planning and readiness in due course. InflaRx sees significant potential for izicopan to address unmet needs in multiple I&I indications beyond HS, including CSU, where InflaRx continues data analysis and active dialog with thought leaders to determine next steps. Given the supportive nature of the Phase 2a data collected to-date from the two main CSU (all-comer) dosing cohorts, and low enrollment trends in the third (anti-IgE refractory) dosing cohort, InflaRx has decided to close the third treatment cohort. InflaRx will utilize the existing data set to determine next steps for izicopan in CSU, which the Company expects to communicate later this year. InflaRx intends to submit the izicopan Phase 2a datasets in HS and CSU for presentation at medical conferences later this year. Toward the goal of generating proof of concept data in additional I&I indications as efficiently as possible, InflaRx intends to conduct a PK bridging study with izicopan in China this year in order to expedite subsequent proof of concept studies in China and elsewhere. The Company intends to provide an update on these efforts, and on efforts in additional potential I&I indications, later this year. InflaRx expects to host a virtual capital markets day this spring. During this event the Company plans to highlight the clinical utility of izicopan in HS and I&I more broadly, including izicopan’s role in respective I&I treatment algorithms, and its emerging commercial potential. Izicopan (INF904) is an orally administered, small molecule inhibitor of the C5a receptor Ca5R1 that has shown anti-inflammatory therapeutic effects in several pre-clinical disease models and in human studies. Further, in contrast to the marketed C5aR inhibitor, in vitro experiments demonstrated that izicopan has minimal inhibition of the cytochrome P450 3A4/5 (CYP3A4/5) enzymes, which play an important role in the metabolism of a variety of metabolites and drugs, including glucocorticoids. Reported results from a first-in-human study demonstrated that izicopan was well tolerated in treated subjects and exhibited no safety signals of concern in single doses ranging from 3 mg to 240 mg or multiple doses ranging from 30 mg once per day to 90 mg twice per day for 14 days. Pharmacokinetic / pharmacodynamic data support the best-in-class potential of izicopan, with a ≥90% blockade of C5a-induced neutrophil activation achieved over the 14-day dosing period. Topline Phase 2a data further support the safety profile of izicopan, with no reported safety signals of concern. In patients with hidradenitis suppurativa, over 4 weeks of therapy, izicopan provided rapid and clinically meaningful reductions in abscesses and nodules (ANs) and draining tunnels (dTs), robust HiSCR responses that continued to deepen four weeks after the treatment period, and substantial reductions in patient-reported pain scores, overall demonstrating the potential for biologic-like efficacy. In chronic spontaneous urticaria, InflaRx observed substantial reductions in the 7-day Urticaria Activity Score (UAS7) broadly across patients and particularly in those with severe disease, as well as improved disease control as measured by the Urticaria Control Test (UCT7). InflaRx (Nasdaq: IFRX) is a biopharmaceutical company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5aR technologies to discover, develop and commercialize highly potent and specific inhibitors of the complement activation factor C5a and its receptor, C5aR. C5a is a powerful inflammatory mediator involved in the progression of a wide variety of inflammatory diseases. InflaRx‘s lead program is izicopan (INF904), an orally administered small molecule inhibitor of C5a-induced signaling via the C5a receptor, which has shown promising PK/PD characteristics as well as therapeutic potential in Phase 1 and Phase 2a clinical studies. The company is developing izicopan for the treatment of several inflammatory diseases, including hidradenitis suppurativa (HS). The Company has also developed vilobelimab, a novel, intravenously delivered, first-in-class, anti-C5a monoclonal antibody that selectively binds to free C5a and has demonstrated disease-modifying clinical activity and tolerability in multiple clinical studies. InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information, please visit www.inflarx.de. InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx). The content above comes from the network. if any infringement, please contact us to modify.

Clinical Result

04 Jan 2026

·www.globenewswire.com

InflaRx Provides Update on Phase 3 Data Analyses for Vilobelimab in Pyoderma Gangrenosum

While the Phase 3 trial of vilobelimab in ulcerative pyoderma gangrenosum (PG) was terminated earlier this year due to futility regarding its prespecified primary endpoint (as previously disclosed), subsequent post-hoc analyses suggest a positive trend in favor of vilobelimab, with signals indicating a potentially consistent treatment effect InflaRx anticipates meeting with the FDA to determine a potential development path forward in PG, which the Company anticipates would only be conducted in collaboration with a partner Dec. 30, 2025 -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today outlined multiple data analyses of the Phase 3 study for vilobelimab in pyoderma gangrenosum (PG), which was terminated earlier this year after an Independent Data Monitoring Committee (IDMC) recommended the trial be stopped early due to futility. The analyses disclosed today include the primary intent-to-treat analysis and several post-hoc analyses on the 54 patients enrolled in the trial at the time of study termination. Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, said: “Our Phase 3 study was the first randomized placebo-controlled study in pyoderma gangrenosum using complete target ulcer closure on two consecutive visits as a stringent primary clinical endpoint, which has not been tested before in this rare disease. Our in-depth data analysis reveals signals of efficacy, particularly regarding ulcer volume reduction, which further supports the potential role of the C5a/C5aR pathway in certain neutrophilic skin diseases, such as PG. Depending on the outcome of our anticipated FDA interactions, our results may provide an opportunity to advance development in collaboration with a partner, which we may pursue in the future.” The Phase 3 study had recruited a total of 54 patients at the time the interim analysis was conducted, including 30 patients who had completed 6 months of treatment. The primary clinical endpoint of complete target ulcer closure on two consecutive visits showed a difference in favor of vilobelimab over placebo of 20.8% versus 16.7% (p=NS (not significant)). Key secondary endpoints such as complete disease remission (complete closure of all ulcers) showed improvement in favor of vilobelimab over placebo (20.8% versus 5.6%, p=NS) and those with >50% reduction of target ulcer volume at week 26 (36.4% versus 16.7%, p=NS). In addition, patients reported feeling better as measured by the Dermatology Life Quality Index (DLQI) mean percentage change at the end of treatment visit (-31.1% versus 3.4%). Overall, vilobelimab was well tolerated. Observed treatment-emergent adverse events (TEAEs) were mostly mild to moderate, and patients with serious related on-treatment TEAEs were similarly distributed (6.3% in vilobelimab arm and 4.5% in placebo arm). In addition, further post-hoc analyses showed that there is an overall treatment effect with vilobelimab when compared to placebo. These include an MMRM (mixed model repeated measures) for percent change in target ulcer volume, which showed an average effect over all visits in favor of vilobelimab over placebo (-45.4%, p=0.0428, Weeks 2 – 26 overall) when imputing patients with treatment-related discontinuation reasons, including patient level stopping criteria (PLSC) with a last observation carried forward (LOCF) approach. This analysis yielded a significant treatment difference for every week from Week 14 (-57.6%, p=0.0357) to Week 26 (-63.2%, p=0.0122) for vilobelimab over placebo. In addition, ANCOVAs (analyses of covariance) for mean of percentage changes from baseline in volume and area from Week 12 until Week 26 were also in favor of vilobelimab, including mean of percentage change from baseline in volume (p=0.0111) and area (p=0.0072). These analyses suggest that treatment longer than 26 weeks with vilobelimab may provide improved treatment outcomes in this difficult-to-treat ulcerative PG population. Alex G. Ortega Loayza, MD, MCR, CWSP, Professor and Interim Chair, Department of Dermatology, Oregon Health and Science University, said: “I am encouraged by the signals of efficacy observed from the Phase 3 post-hoc analyses of vilobelimab in pyoderma gangrenosum. The role of targeting C5a/C5aR aligns with prior mechanistic work supporting its use for this devastating inflammatory dermatological disease, which has no FDA-approved therapy. Given the significant unmet need and lack of approved therapies, I am hopeful these findings will motivate further investigation of this targeted approach.” Benjamin Kaffenberger, MD, Associate Professor, Dermatology, The Ohio State University Wexner Medical Center, said: “Pyoderma gangrenosum remains a difficult-to-treat rare disease with high unmet medical need. The data for vilobelimab suggest an overall treatment effect, even if the primary endpoint may not have been achieved within the six-month timeframe required in this first-of-its-kind Phase 3 trial. Unfortunately, there is not a successful precedent for conducting a pivotal Phase 3 placebo-controlled study in PG, and I believe the futility leading to early discontinuation relates to challenges in trial design rather than lack of efficacy of the therapy. I believe that blocking C5a/C5aR in this neutrophilic disease continues to make scientific and clinical sense and that there is a strong justification to move forward.” As next steps, InflaRx anticipates meeting with the FDA to discuss a potential path forward for vilobelimab in PG, including the use of alternative endpoints that could be utilized for potential future clinical studies. At this time, in an effort to prioritize izicopan (INF904) development, InflaRx does not expect to deploy significant resources towards future vilobelimab development in PG on its own and will instead consider doing so in collaboration with a partner. Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism of the innate immune system, which is not the case for molecules blocking C5. In pre-clinical studies, vilobelimab has been shown to control the inflammatory response-driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response. InflaRx (Nasdaq: IFRX) is a biopharmaceutical company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5aR technologies to discover, develop and commercialize highly potent and specific inhibitors of the complement activation factor C5a and its receptor, C5aR. C5a is a powerful inflammatory mediator involved in the progression of a wide variety of inflammatory diseases. InflaRx has developed vilobelimab, a novel, intravenously delivered, first-in-class, anti-C5a monoclonal antibody that selectively binds to free C5a and has demonstrated disease-modifying clinical activity and tolerability in multiple clinical studies. InflaRx is also developing izicopan (INF904), an orally administered small molecule inhibitor of C5a-induced signaling via the C5a receptor. InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information, please visit www.inflarx.de. InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx). The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultImmunotherapy

02 Jan 2026

·www.fiercepharma.com

After scrapped trial, InflaRx could tap partner to revive development of COVID drug in rare skin disorder

Less than a year ago, InflaRx nixed its pyoderma gangrenosum study of vilobelimab after an independent data monitoring committee called for the trial’s early termination. Although it looked to be lights out for InflaRx’s C5a antibody vilobelimab in the rare skin disorder pyoderma gangrenosum (PG) last year, the German drugmaker ended 2025 with a glimmer of hope for the asset, thanks to multiple analyses of a terminated phase 3 trial.Following the end of the late-stage study in ulcerative PG last May over futility, post hoc analyses have pointed to a “positive trend in favor of vilobelimab, with signals indicating a potentially consistent treatment effect,” InflaRx said in a Dec. 30 press release.In turn, the company—which is broadly seeking to develop inflammatory drugs targeting the complement system—anticipates meeting with the FDA to hash out a potential development path forward for its drug in PG. InflaRx said it expects that any revamped development efforts in the indication “would only be conducted in collaboration with a partner.”“Our in-depth data analysis reveals signals of efficacy, particularly regarding ulcer volume reduction, which further supports the potential role of the C5a/C5aR pathway in certain neutrophilic skin diseases, such as PG,” Niels Riedemann, M.D., Ph.D., InflaRx’s chief executive, said in a statement.“Depending on the outcome of our anticipated FDA interactions, our results may provide an opportunity to advance development in collaboration with a partner, which we may pursue in the future,” he continued. PG is a rare skin condition that causes large, painful sores to form on the skin, frequently on the legs. The exact cause of the condition isn’t fully understood, though it is believed to be an immune disorder, according to the Mayo Clinic.For its part, vilobelimab is designed to block the activity of C5a—a fragment of the immune system’s complement cascade—and has demonstrated “high selectivity towards its targets in human blood,” InflaRx noted in its release. The company stressed that, unlike drugs designed to block C5, vilobelimab leaves the formation of the membrane attack complex intact, recognizing it as an “important defense mechanism of the innate immune system.”Less than a year ago, InflaRx nixed its PG study of vilobelimab after an independent data monitoring committee called for the trial’s early termination, citing futility. The recommendation, which the data monitoring committee leveled after analyzing results on the first 30 patients enrolled in the trial, prompted InflaRx to declare it was stopping development of vilobelimab in the indication.While InflaRx has no drugs with full FDA approvals, vilobelimab boasts an emergency use authorization (EUA) to treat certain critically ill COVID-19 patients. The termination of the PG study in May had no bearing on the EUA or on vilobelimab’s status in the U.S. as a COVID treatment, InflaRx clarified last year. The antibody drug is marketed under the name Gohibic in its COVID-19 niche.As for the latest interpretation of the PG data, InflaRx said it leveraged its primary intent-to-treat analysis and several more post hoc assessments on the 54 participants enrolled in the study at the time of termination. That patient pool included 30 who had completed half a year of treatment on vilobelimab, the company pointed out.Notably, the primary clinical endpoint of complete target ulcer closure on two consecutive visits revealed a difference favoring vilobelimab (20.8%) over placebo (16.7%), despite not being significant enough to satisfy the trial as designed, InflaRx said.InflaRx also flagged trends favoring its drug across several key secondary endpoints in the terminated study.For instance, nearly 30% of patients on vilobelimab achieved complete disease remission—defined by the complete closure of all ulcers—versus just 5.6% of patients in the study’s control cohort. Vilobelimab further helped 36.4% of patients reduce their ulcer volume by 50% or more at 26 weeks, compared to 16.7% of patients on placebo.InflaRx additionally flagged further post hoc analyses that suggest “there is an overall treatment effect with vilobelimab when compared to placebo.”The German drugmaker said it used a mixed model for repeated measures for percent change in target ulcer volume and analyses of covariance for mean of percentage changes from baseline in volume over a certain time span to further crack open the data. Those subsequent analyses yielded a “significant treatment difference” for vilobelimab over placebo from Week 14 to Week 26 of treatment and suggested vilobelimab dosing beyond 26 weeks “may provide improved treatment outcomes.”“Unfortunately, there is not a successful precedent for conducting a pivotal Phase 3 placebo-controlled study in PG, and I believe the futility leading to early discontinuation relates to challenges in trial design rather than lack of efficacy of the therapy,” Benjamin Kaffenberger, M.D., of The Ohio State University Wexner Medical Center, said in InflaRx’s release.“I believe that blocking C5a/C5aR in this neutrophilic disease continues to make scientific and clinical sense and that there is a strong justification to move forward,” he added.As for what comes next, InflaRx is expecting to meet with the FDA to discuss a potential development path forward in PG, possibly through the use of alternative endpoints.At the time of last year’s trial termination, InflaRx noted that it would focus its resources on its oral small molecule candidate izicopan, which is also a CFa inhibitor. That remains the case heading into 2026, as well.In a bid to prioritize izicopan’s development in conditions like chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS), the company noted that it “does not expect to deploy significant resources towards future vilobelimab development in PG on its own and will instead consider doing so in collaboration with a partner.” Back in November, InflaRx unveiled positive phase 2a basket data on izicopan—then coded INF904—in both HS and CSU, flagging the drug’s prospects as a “potentially transformational and best-in-class immunomodulatory agent” in the indications.Meanwhile, over the summer, InflaRx indicated that it believes CSU and HS could each represent markets of $1 billion or more for izicopan. At the time, the company noted that it had around 53.7 million euros in cash and equivalents, plus about 40.7 million euros in marketable securities. That should provide InflaRx with a cash runway stretching into 2027, InflaRx said in August.

Phase 3Phase 2Clinical Result

100 Deals associated with Vilobelimab

External Link

KEGG	Wiki	ATC	Drug Bank
D11838	-	-	DB16416

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Respiratory Distress Syndrome, Acute	European Union	InflaRx GmbH	13 Jan 2025
Respiratory Distress Syndrome, Acute	Iceland	InflaRx GmbH	13 Jan 2025
Respiratory Distress Syndrome, Acute	Liechtenstein	InflaRx GmbH	13 Jan 2025
Respiratory Distress Syndrome, Acute	Norway	InflaRx GmbH	13 Jan 2025
COVID-19	United States	InflaRx NV	04 Apr 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pyoderma Gangrenosum	Phase 3	United States	InflaRx GmbH	01 Nov 2023
Pyoderma Gangrenosum	Phase 3	Australia	InflaRx GmbH	01 Nov 2023
Pyoderma Gangrenosum	Phase 3	Belgium	InflaRx GmbH	01 Nov 2023
Pyoderma Gangrenosum	Phase 3	France	InflaRx GmbH	01 Nov 2023
Pyoderma Gangrenosum	Phase 3	Germany	InflaRx GmbH	01 Nov 2023
Pyoderma Gangrenosum	Phase 3	Hungary	InflaRx GmbH	01 Nov 2023
Pyoderma Gangrenosum	Phase 3	Italy	InflaRx GmbH	01 Nov 2023
Pyoderma Gangrenosum	Phase 3	Poland	InflaRx GmbH	01 Nov 2023
Pyoderma Gangrenosum	Phase 3	Spain	InflaRx GmbH	01 Nov 2023
Pyoderma Gangrenosum	Phase 3	Switzerland	InflaRx GmbH	01 Nov 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05964413 (Company_Website) Manual	Phase 3	Pyoderma Gangrenosum	54	Vilobelimab	lwrrqawrqb(othzjujkfl) = fbygegqizw axckymyjya (yuvrdfbyne ) View more	Negative	30 Dec 2025
				Placebo	lwrrqawrqb(othzjujkfl) = ekxwsetmhw axckymyjya (yuvrdfbyne ) View more
NCT03487276 (SHINE, Pubmed \| Br J Dermatol)	Phase 2	Hidradenitis Suppurativa	177	Vilobelimab	kmoafmhseh(yxvrfpqoih) = sgytuzexwq jgybilepnz (tpetpgdgjr ) View more	Negative	13 Oct 2025
NCT05964413 (Biospace) Manual	Phase 3	Pyoderma Gangrenosum	-	vilobelimab	fnbiykwxvg(szuoxoyjbo) = InflaRx’s vilobelimab met the bar for futility in a Phase III trial for the rare skin disease pyoderma gangrenosum. nswakccmhh (dwdqskwpoa ) Not Met	Negative	28 May 2025
ATS2025	Not Applicable	Legionellosis \| COVID-19 \| MRSA - Methicillin resistant Staphylococcus aureus infection SARS-CoV-2 PCR+ \| MRSA PCR+ \| Legionella+	1	Vilobelimab 800mg	fqcjuwxhvr(qiopsuhxcp) = rftbvwlfen xojlmxoifk (uvfmongzuo ) View more	Positive	16 May 2025
PANAMO (ATS2025)	Phase 3	Respiratory Distress Syndrome, Acute SARS-CoV-2 infection	-	Vilobelimab 800mg + standard-of-care (SOC)	mfalgdtxwa(tnipdhsewc): HR = 0.75 (95% CI, 0.48 - 1.16), P-Value = 0.19	Positive	16 May 2025
				Placebo + standard-of-care (SOC)
NCT03487276 (AAD2025)	Phase 2	Hidradenitis Suppurativa	177	Vilobelimab 400mg Q4W	xatwyjwfxi(qywalftsgh) = bfzryonygz zslctxjxtc (bttkhgxcmz ) View more	Positive	07 Mar 2025
				Vilobelimab 800mg Q4W	xatwyjwfxi(qywalftsgh) = jyezoptalr zslctxjxtc (bttkhgxcmz ) View more
NCT03001622 (AAD2025)	Phase 2	Hidradenitis Suppurativa	15	Vilobelimab 800mg (Hidradenitis Suppurativa)	otighrrwra(hiwapjyfpr) = There were no significant changes in C3a concentrations. zlotvyujca (fwnbxtjqyy ) View more	Positive	07 Mar 2025
AAD2025	Phase 2	Pyoderma Gangrenosum	19	Vilobelimab 1600mg	rgytfgnsdj(jahgqzsbxo) = No consistent increases or decreases in C3a concentrations were observed by dose or visit in the study. tqvlxybtiv (wvipbbwbst ) View more	Positive	07 Mar 2025
				Vilobelimab 2400mg
NCT03487276 (AAD2025)	Phase 2	Hidradenitis Suppurativa	177	Vilobelimab 400mg Q4W	fxzgoduxrq(kwoesewnwi) = gkvnargfsd nmeparkdcr (waeqcbhnhf ) View more	Positive	07 Mar 2025
				Placebo	uieozoyffu(kfwifcnljt) = kfdydsdxqh cobumsxoun (epxrqatllm ) View more
NCT04812535 (CTgov)	Phase 2	Cutaneous Squamous Cell Carcinoma	30	Vilobelimab (Arm A:)	kaehxpmclj = bqwquvuqjp xeisdpykia (chgiejernf, uistzrjall - ygzylofbmg) View more	-	11 Feb 2025
				Vilobelimab+pembrolizumab (Arm B: Regimen 1:)	idwyypcemq(iwrllyngij) = zlgphdvkvu kihdjzgqwy (kiywjjkjyy, syfdviuuui - ddyaqeeicb) View more

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