InflaRx Announces First Patient Dosed in Phase 2a Study for Oral C5aR Inhibitor INF904
InflaRx has initiated dosing in its Phase 2a basket study for INF904, an oral C5aR inhibitor, targeting chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS). The study will enroll 75 patients, with 45 CSU patients receiving doses of 60mg or 120mg BID, and 30 HS patients randomized across 60mg, 90mg, or 120mg BID doses over 4 weeks. The trial aims to evaluate safety, pharmacokinetics, and clinical benefits, with data expected in summer 2025. Each indication represents potential addressable markets of $1 billion or more. The company plans to use study results to design a larger Phase 2b trial by year-end 2025.
InflaRx ha avviato la somministrazione nel suo studio di fase 2a a cesta per INF904, un inibitore orale del C5aR, mirato alla cura dell'orticaria spontanea cronica (CSU) e dell'atteggiamento hidradenitis suppurativa (HS). Lo studio arruolerà 75 pazienti, di cui 45 con CSU riceveranno dosi di 60mg o 120mg due volte al giorno (BID), mentre 30 pazienti con HS saranno randomizzati tra dosi di 60mg, 90mg o 120mg BID per un periodo di 4 settimane. L'obiettivo della sperimentazione è valutare la sicurezza, la farmacocinetica e i benefici clinici, con dati attesi per l'estate del 2025. Ogni indicazione rappresenta potenziali mercati indirizzabili di 1 miliardo di dollari o più. L'azienda prevede di utilizzare i risultati dello studio per progettare una trial di fase 2b più ampia entro la fine del 2025.
InflaRx ha iniciado la administración en su estudio de fase 2a en red para INF904, un inhibidor oral del C5aR, dirigido al tratamiento de la urticaria espntanea crónica (CSU) y la hidradenitis supurativa (HS). El estudio inscribirá a 75 pacientes, con 45 pacientes de CSU que recibirán dosis de 60mg o 120mg dos veces al día (BID), y 30 pacientes de HS que serán aleatorizados en dosis de 60mg, 90mg o 120mg BID durante 4 semanas. El ensayo tiene como objetivo evaluar la seguridad, la farmacocinética y los beneficios clínicos, con datos esperados para el verano de 2025. Cada indicación representa mercados potenciales direccionables de 1 mil millones de dólares o más. La compañía planea utilizar los resultados del estudio para diseñar un ensayo más grande de fase 2b para finales de 2025.
InflaRx는 만성 자발적 두드러기(CSU) 및 삼차선 발한증(HS)을 대상으로 하는 경구 C5aR 억제제인 INF904의 2a상 바구니 연구에서 투약을 시작했습니다. 연구에는 75명의 환자가 등록되며, CSU 환자 45명은 하루 두 번( BID) 60mg 또는 120mg의 용량을 받고, HS 환자 30명은 60mg, 90mg 또는 120mg의 BID 용량에 무작위로 배정되어 4주 동안 관찰됩니다. 이 시험의 목표는 안전성, 약동학 및 임상적 이점을 평가하는 것이며, 데이터는 2025년 여름에 예상됩니다. 각 적응증은 10억 달러 이상의 잠재적 시장을 나타냅니다. 이 회사는 연구 결과를 바탕으로 2025년 말까지 더 큰 2b상 시험을 설계할 계획입니다.
InflaRx a lancé la dose dans son étude de phase 2a en panier pour INF904, un inhibiteur oral du C5aR, visant la prise en charge de l'urticaire chronique spontanée (CSU) et de la hidradenitis suppurativa (HS). L'étude recrutera 75 patients, avec 45 patients CSU recevant des doses de 60mg ou 120mg deux fois par jour (BID), et 30 patients HS randomisés recevant des doses de 60mg, 90mg ou 120mg BID sur une période de 4 semaines. L'essai vise à évaluer la sécurité, la pharmacocinétique et les bénéfices cliniques, avec des données attendues à l'été 2025. Chaque indication représente des marchés adressables potentiels d'1 milliard de dollars ou plus. L'entreprise prévoit d'utiliser les résultats de l'étude pour concevoir un essai plus vaste de phase 2b d'ici la fin 2025.
InflaRx hat die Dosierung in seiner Phase-2a-Basket-Studie für INF904, einen oralen C5aR-Inhibitor, aufgenommen, der sich auf die Behandlung von chronischer spontaner Urtikaria (CSU) und Hidradenitis suppurativa (HS) konzentriert. Die Studie wird 75 Patienten einschließen, wobei 45 CSU-Patienten Dosen von 60mg oder 120mg zweimal täglich (BID) erhalten und 30 HS-Patienten randomisiert, wobei sie entweder 60mg, 90mg oder 120mg BID über 4 Wochen erhalten. Ziel der Studie ist es, Sicherheit, Pharmakokinetik und klinische Vorteile zu bewerten, wobei mit Daten im Sommer 2025 zu rechnen ist. Jede Indikation stellt potenzielle adressierbare Märkte von 1 Milliarde Dollar oder mehr dar. Das Unternehmen plant, die Ergebnisse der Studie zu nutzen, um bis Ende 2025 eine größere Phase-2b-Studie zu entwerfen.
- First patient dosed in Phase 2a trial, indicating progress in clinical development
- Phase 1 results showed INF904 was well-tolerated with no safety concerns
- Each target indication (CSU and HS) represents potential $1B+ market opportunity
- INF904 achieved ≥90% blockade of C5a-induced neutrophil activation in Phase 1
- Final data not expected until summer 2025
- Additional larger Phase 2b study will be required, extending development timeline
- Multiple competing doses being tested indicates optimal dosing still uncertain
Insights
The initiation of Phase 2a trials for INF904 marks a critical development milestone for InflaRx. The study's design is particularly sophisticated, employing a basket trial approach that simultaneously evaluates two significant indications - chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS). The trial structure, involving 75 patients across multiple dosing regimens, is optimized to generate comprehensive data on both safety and early efficacy signals.
The commercial potential is substantial, with each indication representing potential
The study's endpoints are well-chosen, incorporating both objective measures (UAS7, HSS7, ISS7 for CSU; lesion counts for HS) and patient-reported outcomes, which will be important for regulatory submissions and market positioning. The expected data readout in summer 2025 could be a significant catalyst for the company's valuation.
INF904's development represents a strategic advantage in the competitive landscape of inflammatory disease treatments. The oral administration route offers a significant market differentiation from existing injectable therapies, potentially improving patient compliance and market penetration. The minimal CYP3A4/5 enzyme inhibition profile is particularly noteworthy, as it suggests reduced drug-drug interactions, a important advantage for patients on multiple medications.
The company's market strategy appears well-conceived, focusing on established indications while maintaining flexibility for expansion through partnerships. With a current market cap of
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
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 ≥
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:
| 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 |
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FAQ
When will InflaRx (IFRX) report Phase 2a results for INF904?
How many patients will be enrolled in InflaRx's INF904 Phase 2a trial?
What are the dosing levels for INF904 in the IFRX Phase 2a study?
What is the market potential for INF904 in CSU and HS?
What were the safety results from INF904's Phase 1 trial?
