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InflaRx N.V. Report: Phase 2a Study for INF904 Dosing Begins!

$IFRX
Form 6-K
Filed on: 2024-12-20
Source
InflaRx N.V. Report: Phase 2a Study for INF904 Dosing Begins!

Based on the provided section of the financial report (Form 6-K) for InflaRx N.V., here are the key points and insights extracted:

  1. Company Overview:
  • Name: InflaRx N.V.
  • Address: Winzerlaer Str. 2, 07745 Jena, Germany.
  • Commission File Number: 001-38283.
  1. Report Details:
  • Filing Date: December 20, 2024.
  • Purpose: The report is submitted as a foreign private issuer under the Securities Exchange Act of 1934.
  1. Key Announcement:
  • InflaRx announced that the first patient has been dosed in its Phase 2a clinical study for the oral C5aR inhibitor, INF904. This study targets conditions such as chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS).
  1. Study Details:
  • Study Type: Multi-center, open-label Phase 2a basket study.
  • Patient Population: 75 patients with moderate-to-severe CSU and HS.
  • Duration: 4 weeks of treatment with follow-up for an additional 4 weeks.
  • Objective: To evaluate multiple dosing regimens, gather safety and pharmacokinetic data, and assess clinical benefits.
  • Data Timeline: Results are expected in the summer of 2025, which will inform a potential larger Phase 2b study by the end of 2025.
  1. Regulatory References:
  • The report will be incorporated by reference into the company’s registration statements on Form S-8 and Form F-3.
  1. Forward-Looking Statements:
  • The report includes forward-looking statements regarding the company’s expectations and potential outcomes. It emphasizes that these statements involve risks and uncertainties and should not be relied upon excessively.
  1. Signatory Information:
  • The report is signed by Niels Riedemann, Chief Executive Officer of InflaRx N.V.
  1. Exhibits:
  • A press release dated December 20, 2024, is attached as Exhibit 99.1, detailing the announcement about the clinical study.

This summary highlights the company's ongoing clinical trials and provides insight into its strategic direction in drug development, particularly with the oral C5aR inhibitor, INF904. The timeline for results and further studies indicates a proactive approach to expanding its clinical research portfolio.