InflaRx Advances Pipeline with Vilobelimab and INF904, Anticipates Key Milestones in 2025
核心洞察
InflaRx (搜索)'s Phase 3 trial of vilobelimab for pyoderma gangrenosum (搜索) (PG) reached its 30-patient recruitment milestone, with an interim analysis expected by the end of Q2 2025.
A Phase 2a trial for INF904, targeting chronic spontaneous urticaria (搜索) (CSU) and hidradenitis suppurativa (搜索) (HS), is set to begin by the end of 2024, with initial data expected in summer 2025.
The European Committee for Medicinal Products for Human Use (CHMP) is reviewing vilobelimab, with a decision anticipated around mid-November.
InflaRx (搜索) N.V. (Nasdaq: IFRX) has announced its third-quarter 2024 financial results and provided a business update, highlighting progress in its clinical programs for vilobelimab and INF904. The company is focused on advancing its pipeline of anti-inflammatory therapeutics targeting the complement system.
Vilobelimab in Pyoderma Gangrenosum (PG)
The Phase 3 trial of vilobelimab for pyoderma gangrenosum (搜索) (PG) has reached a key milestone with the recruitment of 30 patients. This achievement enables an interim analysis, which is expected to provide guidance on potential trial size adaptation or futility by the end of the second quarter of 2025. The study is a multi-national, randomized, double-blind, placebo-controlled trial assessing the benefit of vilobelimab for treating ulcerative PG. The primary endpoint is complete closure of the target ulcer at any time up to 26 weeks after treatment initiation. Vilobelimab has been granted orphan drug designation for PG by both the FDA and EMA, and also has fast track designation by the FDA.
INF904 Phase 2a Trial
InflaRx (搜索) is preparing to initiate a Phase 2a basket trial for INF904 by the end of 2024, with initial data expected in the summer of 2025. This multi-center, open-label study will involve 75 patients and evaluate multiple INF904 dosing regimens over 4 weeks of treatment in patients with moderate-to-severe chronic spontaneous urticaria (搜索) (CSU) and moderate-to-severe hidradenitis suppurativa (搜索) (HS). The objective of this Phase 2a trial is to generate additional safety and pharmacokinetic (PK) data and provide signs of clinical benefit, informing the design of a Phase 2b trial planned for late 2025.
Vilobelimab MAA Review
The Marketing Authorization Application (MAA) for vilobelimab in the European Union (EU) is under review by the Committee for Medicinal Products for Human Use (CHMP). The application seeks approval for the treatment of SARS-CoV-2 induced septic acute respiratory distress syndrome (ARDS) receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). A CHMP opinion is anticipated around mid-November.
Financial Position
As of September 30, 2024, InflaRx (搜索) reported cash, cash equivalents, and marketable securities of €62.0 million. The company believes these funds will be sufficient to finance operations into 2026. "We continue to focus on efficiently utilizing our resources to advance our pipeline of complement inhibitors...InflaRx remains funded into 2026, and we look forward to reaching our next value inflection points," said Dr. Thomas Taapken, Chief Financial Officer of InflaRx.
About INF904
INF904 is an orally administered, small molecule inhibitor of the C5a receptor (搜索) 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.