InflaRx Highlights Clinical Activity of Vilobelimab in Pyoderma Gangrenosum in Late-Breaker Oral Presentation at 2026 American Academy of Dermatology Annual Meeting

InflaRx (Nasdaq: IFRX) presented Phase 3 vilobelimab data for pyoderma gangrenosum at the 2026 AAD Annual Meeting (March 27-31, 2026).

Rhea-AI Summary

InflaRx (Nasdaq: IFRX) presented Phase 3 vilobelimab data for pyoderma gangrenosum at the 2026 AAD Annual Meeting (March 27-31, 2026). The trial enrolled 54 patients and was stopped early for futility. Results showed higher complete remission and ulcer-closure rates, strong C5a suppression (-76.6% vs -13.5%), and a generally favorable safety profile.

The company plans FDA discussions on a PG development path and expects future PG work likely with a partner.

Positive

• Complete remission rate with vilobelimab 20.8%
• Complete target ulcer closure with vilobelimab 20.8% vs placebo 16.7%
• Ulcer volume reduction >50% in 36.4% of vilobelimab patients
• C5a levels reduced by −76.6% versus −13.5% with placebo

Negative

• Phase 3 trial terminated early for futility after 54 patients enrolled
• Primary endpoint 95% CI included zero (95% CI: −19.5%, 27.8%)
• Complete remission 95% CI wide and overlapping placebo (95% CI: −4.1%, 34.7%)

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On Mar 30, the day this news came out, IFRX closed 8.79% below the previous close.

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Key Figures

Trial enrollment: 54 patients Primary endpoint response: 20.8% vs 16.7% Complete remission rate: 20.8% vs 5.1% +5 more

Trial enrollment

54 patients

Phase 3 vilobelimab study in pyoderma gangrenosum before early termination

Primary endpoint response

20.8% vs 16.7%

Complete target ulcer closure, vilobelimab vs placebo

Complete remission rate

20.8% vs 5.1%

Complete disease remission, vilobelimab vs placebo

Ulcer volume reduction

36.4% vs 16.7%

>50% ulcer volume reduction, vilobelimab vs placebo

C5a level change

-76.6% vs -13.5%

Mean change from baseline, vilobelimab vs placebo

Serious adverse events

6.3% vs 4.5%

Serious adverse event rates, vilobelimab vs placebo

Trial status

Terminated for futility

Phase 3 vilobelimab PG trial stopped per Independent Data Monitoring Committee

DLQI and PGA trends

Trends favor vilobelimab

Dermatology Life Quality Index and Physician Global Assessment outcomes

Historical Context

5 past events · Latest: Mar 19

5 events

1. Mar 19

   Full-year results

   24h Move

   +3.4%

   Full-year 2025 results and positive izicopan Phase 2a data with cash runway.

2. Mar 18

   Clinical presentation

   24h Move

   -3.6%

   Announcement of late-breaking oral presentation on vilobelimab Phase 3 PG results.

3. Mar 12

   Earnings date set

   24h Move

   +2.0%

   Scheduling of full-year 2025 earnings release without additional new clinical data.

4. Feb 26

   Conference participation

   24h Move

   -0.3%

   Planned participation in Leerink Global Healthcare Conference with fireside chat.

5. Jan 29

   Investor conferences

   24h Move

   +1.3%

   Participation in February investor conferences highlighting izicopan and vilobelimab.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

phase 3, pyoderma gangrenosum, dermatology life quality index, physician global assessment, +4 more

8 terms

phase 3 medical

"data from the Phase 3 study of vilobelimab in pyoderma gangrenosum (PG)"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

pyoderma gangrenosum medical

"Phase 3 study of vilobelimab in pyoderma gangrenosum (PG) were featured"

A rare, painful inflammatory skin disorder that produces rapidly expanding ulcers and deep wounds, often following minor injury or linked to immune-system abnormalities; it can be hard to heal and may recur. It matters to investors because it represents a clear unmet medical need and a distinct clinical and regulatory challenge—new effective therapies can create commercial opportunity, affect trial outcomes and safety profiles, and influence valuation of companies developing treatments.

dermatology life quality index medical

"Physician Global Assessment (PGA) scores and Dermatology Life Quality Index (DLQI)"

A Dermatology Life Quality Index (DLQI) is a short, patient-completed questionnaire that measures how much a skin condition affects a person’s daily life, similar to a customer satisfaction score for health. Investors watch DLQI results because they show whether a treatment meaningfully improves patients’ day-to-day well-being, which can influence regulatory decisions, market demand, pricing, and insurance coverage — all drivers of a therapy’s commercial value.

physician global assessment medical

"Physician Global Assessment (PGA) scores and Dermatology Life Quality Index"

Physician global assessment is a clinician’s overall judgement of a patient’s disease activity or change over time, usually recorded on a simple scale or score. Investors watch this measure because it is commonly used as an efficacy endpoint in clinical trials and regulatory reviews; a favorable physician assessment can signal a treatment’s real-world benefit and strengthen a drug’s prospects for approval and commercial success, much like a coach’s grade reflecting an athlete’s readiness.

c5a medical

"Vilobelimab treatment also was shown to substantially reduce C5a levels"

C5a is a small protein produced by the immune system that acts like an alarm bell, signaling and attracting immune cells to sites of infection or injury and triggering inflammation. Investors care because excessive or uncontrolled C5a activity is linked to many inflammatory and autoimmune diseases, making it a common target for drugs and diagnostics; treatments that block or measure C5a can affect clinical outcomes, regulatory approval prospects, and commercial value in biotech and pharmaceutical portfolios.

monoclonal antibody medical

"Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody"

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

complement system medical

"pioneering anti-inflammatory therapeutics by targeting the complement system"

The complement system is a set of proteins in the blood that act together like a security alarm and cleanup crew for the body’s immune system: they detect threats, tag invaders for removal, and help destroy harmful cells. Investors should care because drugs or diagnostics that target or measure this system can affect treatment effectiveness, safety profiles, and market potential for therapies in immune, inflammatory, and rare disease areas.

placebo controlled medical

"Randomized, Placebo Controlled Phase 3 Trial"

A placebo controlled trial compares a drug or treatment against an inactive substance that looks the same but has no therapeutic effect, so researchers can tell whether the treatment itself works beyond patient expectation. For investors, such trials matter because they are a gold standard for proving effectiveness and reducing bias, and their results strongly influence regulatory approval, market adoption, and the financial value and risk of a healthcare company.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Jena, Germany, March 30, 2026 (GLOBE NEWSWIRE) --  InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today 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 being held March 27-31, 2026, in Denver, CO.

The data presented included encouraging signals of clinical activity across multiple measures, with higher rates of complete remission, target ulcer closure, and reductions in ulcer volume, as well as a positive safety profile.

The presentation, entitled “Vilobelimab Treatment for Ulcerative Pyoderma Gangrenosum: Results from a Multicenter, Randomized, Placebo Controlled Phase 3 Trial”, was given by Benjamin Kaffenberger, MD, Associate Professor, Dermatology, The Ohio State University Wexner Medical Center. 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. Physician Global Assessment (PGA) scores and Dermatology Life Quality Index (DLQI) also showed trends favoring vilobelimab.

Vilobelimab treatment also was shown to substantially reduce C5a levels, with mean change from baseline of -76.6% compared to -13.5% with placebo. The treatment was generally well tolerated, with most adverse events reported as mild to moderate and similar rates of serious adverse events between groups (6.3% in vilobelimab and 4.5% in placebo).

Camilla Chong, MD, Chief Medical Officer of InflaRx, commented: “It is an honor that our Phase 3 study data for vilobelimab in pyoderma gangrenosum were selected for a late-breaking oral presentation at AAD, which reflects the importance of the findings. The data reinforce the biological rationale behind vilobelimab and suggest that it may have meaningful potential for patients suffering from neutrophilic diseases where the C5a/C5aR pathway plays a role. It was a great opportunity to share and discuss these findings with the dermatology community at AAD, and we are excited to explore further development options for vilobelimab in this indication.”

While InflaRx is currently prioritizing its interactions with the dermatology division of the US Food & Drug Administration (FDA) on discussions related to izicopan for the treatment of hidradenitis suppurativa, the Company continues to anticipate meeting with the agency to determine a potential development path forward for vilobelimab in PG. InflaRx expects that any future development activities in PG would likely be conducted only in collaboration with a partner.

About vilobelimab
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.

About InflaRx
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. 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).

Contacts:

InflaRx N.V.	MC Services AG
Jan Medina, CFA Vice President, Head of Investor Relations Email: IR@inflarx.de	Katja Arnold, Laurie Doyle, Dr. Regina Lutz Email: inflarx@mc-services.eu Europe: +49 89-210 2280 U.S.: +1-339-832-0752

FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue,” among others. Forward-looking statements appear in a number of places throughout this release and may include statements regarding our intentions, beliefs, projections, outlook, analyses, current expectations and the risks, uncertainties and other factors described under the heading “Risk factors” and “Cautionary statement regarding forward looking statements” in our periodic filings with the SEC. These statements speak only as of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What were the Phase 3 vilobelimab results for pyoderma gangrenosum reported by InflaRx (IFRX) at AAD 2026?

Vilobelimab showed higher rates of remission and ulcer closure but the trial stopped early for futility. According to the company, complete target ulcer closure occurred in 20.8% of vilobelimab patients versus 16.7% on placebo, with trends favoring vilobelimab on PGA and DLQI.

Why was the vilobelimab Phase 3 PG trial (IFRX) stopped early after enrolling 54 patients?

The trial was stopped after an Independent Data Monitoring Committee recommended early termination for futility. According to the company, the recommendation followed interim data review that did not support continuing the trial as designed.

How did vilobelimab affect C5a levels in the Phase 3 pyoderma gangrenosum study presented by InflaRx (IFRX)?

Vilobelimab markedly reduced C5a levels compared with placebo. According to the company, mean change from baseline was −76.6% with vilobelimab versus −13.5% with placebo, supporting target engagement of the drug.

What safety findings did InflaRx (IFRX) report for vilobelimab in the PG Phase 3 trial at AAD 2026?

Treatment was generally well tolerated with similar serious adverse event rates between groups. According to the company, most adverse events were mild to moderate; serious adverse events occurred in 6.3% of vilobelimab and 4.5% of placebo patients.

What are InflaRx’s next steps for vilobelimab in pyoderma gangrenosum (IFRX) after AAD 2026?

InflaRx intends to meet with the FDA to discuss a potential development path and expects future PG work likely with a partner. According to the company, interactions with the agency will determine feasible next steps for vilobelimab.