InflaRx N.V. Initiates Phase 2a Trial for INF904 in Chronic Spontaneous Urticaria and Hidradenitis Suppurativa

InflaRx has commenced a Phase 2a study for INF904 in chronic spontaneous urticaria and hidradenitis suppurativa, dosing its first patient.

Quiver AI Summary

InflaRx N.V. has announced the initiation of a Phase 2a clinical study for its oral C5aR inhibitor, INF904, targeting chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS). The first patient has been dosed in this multi-center, open-label trial, which aims to include 75 patients and evaluate various dosing regimens over four weeks, focusing on safety, pharmacokinetics, and clinical benefits. The study expects to report results in summer 2025, which will help inform the design of a larger Phase 2b study later that year. INF904 shows potential for addressing significant unmet medical needs in these conditions, as well as other immuno-inflammatory diseases, with each condition potentially representing a market of over $1 billion. The drug is known for its strong anti-inflammatory properties, evidenced in preclinical models and its previous human trials.

Potential Positives

• InflaRx has successfully dosed the first patient in its Phase 2a basket study for INF904, marking a significant milestone in its clinical development.
• The study targets chronic spontaneous urticaria and hidradenitis suppurativa, conditions that InflaRx believes each has potential addressable markets of $1 billion or more, indicating substantial commercial opportunities.
• INF904 has demonstrated best-in-class potential based on positive Phase 1 study results, supporting confidence in its efficacy and safety for moderate-to-severe patients.
• The trial is expected to generate important safety, pharmacokinetic, and clinical benefit data, which will inform the design of a larger Phase 2b study planned for late 2025.

Potential Negatives

• The Phase 2a trial is limited to only 75 patients, which may not provide sufficient data to support strong efficacy claims.
• The trial timeline indicates that it will take until summer 2025 to generate data for analysis, delaying any potential market entry for INF904.
• Forward-looking statements throughout the release highlight significant uncertainty and risks associated with the development of INF904, potentially undermining investor confidence.

FAQ

What is the main focus of InflaRx's Phase 2a study?

The study focuses on chronic spontaneous urticaria and hidradenitis suppurativa, using the oral C5aR inhibitor INF904.

How many patients will participate in the Phase 2a trial?

The trial is expected to include a total of 75 patients with moderate-to-severe chronic spontaneous urticaria and hidradenitis suppurativa.

What are the expected results timeline for this study?

Data from the study are anticipated in the summer of 2025, guiding a larger Phase 2b study by year-end 2025.

What is the significance of INF904?

INF904 is an oral C5a receptor inhibitor with demonstrated anti-inflammatory properties, targeting unmet medical needs in specific conditions.

What is InflaRx's expertise in biopharmaceutical development?

InflaRx specializes in anti-inflammatory therapeutics, particularly C5a and C5aR inhibitors, for treating various inflammatory diseases.

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.

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Full Release

JENA, Germany, Dec. 20, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced that the first patient has been dosed in its Phase 2a basket study in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS), investigating the Company’s oral C5aR inhibitor, INF904.

Camilla Chong, MD, Chief Medical Officer of InflaRx, commented:

“We are pleased to have started our Phase 2a trial for INF904 with the first patient dosed at one of our U.S. sites, and I am very proud of our team who implemented this important study so rapidly. We believe there is strong evidence of INF904’s anti-inflammatory properties and that its best-in-class potential will go a long way to serve unmet medical needs in both chronic spontaneous urticaria and hidradenitis suppurativa, and in other immuno-inflammatory conditions as well.”

INF904 Phase 2a Study



The Phase 2a trial is a multi-center, open-label study expected to include a total of 75 patients with moderate-to-severe CSU and moderate-to-severe HS. The trial will evaluate multiple INF904 dosing regimens over 4 weeks of treatment to generate additional safety and pharmacokinetic (PK) data and to provide signs of clinical benefit. As previously disclosed, this basket study is utilizing a commercially viable formulation of INF904, providing a range of drug exposures comparable to the reported levels in the

Phase 1 study

. After the 4-week treatment period, patients will be followed for an additional 4 weeks. Data from this study are expected in the summer of 2025, with a goal of informing the design of a larger, longer-term Phase 2b study by year-end 2025.

In the CSU group, a total of 45 patients will be dosed in three study arms. Patients in Study Arms 1 and 2 will be randomized at a 1:1 ratio to 2 doses of INF904 at 60 mg or 120 mg BID (twice daily), a range of drug exposures comparable to the Phase 1 trial. Patients in Study Arm 3 will be comprised of anti-IgE treatment non-responders and dosed at 120 mg BID. In addition to safety and PK parameters, assessed CSU efficacy measures will include change in the Urticaria Activity Score 7 (UAS7), Hives Severity Score (HSS7) and Itch Severity Score (ISS7) from baseline to the end of week 4. Responder analyses, biomarkers and Patient-Reported Outcome (PRO) endpoints related to urticaria control and quality of life will also be assessed.

In the HS group, 30 patients will be randomized at a 1:1:1 ratio to 3 doses of INF904 at 60 mg, 90 mg or 120 mg BID, a range of drug exposures comparable to the Phase 1 trial. In addition to safety and PK parameters, assessed HS efficacy measures will include change in total abscess, inflammatory nodule and draining tunnel (dT) count, HS lesions-related scores and Clinician’s Global Impression of Change (CGI-C) at 4 weeks. PRO endpoints related to HS disease control, pain and quality of life will also be assessed.

InflaRx believes CSU and HS each has potential addressable markets of $1 billion or more for INF904. The Company also believes INF904 could address meaningful opportunities in additional immuno-dermatology and immuno-inflammatory indications, including in nephrology, neurology and hematology. While InflaRx intends to focus its resources on its immediate goals addressing CSU and HS, the Company continues to assess and monitor the value of pursuing additional areas and applications via potential future collaborations with partners.

About INF904




INF904 is an orally administered, small molecule inhibitor of the C5a receptor that has shown anti-inflammatory therapeutic effects in several pre-clinical disease models. Further, in contrast to the marketed C5aR inhibitor, in vitro experiments demonstrated that INF904 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 INF904 is well tolerated in treated subjects and exhibits 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 (QD) to 90 mg twice per day (BID) for 14 days. PK / pharmacodynamic data support the best-in-class potential of INF904 with a ≥90% blockade of C5a-induced neutrophil activation achieved over the 14-day dosing period.

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 product candidate, vilobelimab, is 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 in different indications. InflaRx is also developing INF904, an orally administered small molecule inhibitor of 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.com

.

InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx).

Contacts:

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 U.S. Securities and Exchange Commission. 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.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.