InflaRx N.V. filed a Form 6-K on November 6, 2026, reporting the peer-reviewed publication of first-in-human Phase 1 clinical data for its oral C5aR1 inhibitor izicopan, formerly known as INF904.

Key Highlights

  • Publication type: Peer-reviewed first-in-human Phase 1 clinical data for izicopan (formerly INF904) was published, according to the filing.
  • Study population: The SAD and MAD study enrolled 86 healthy participants, the filing states.
  • Single ascending doses tested: Izicopan was administered at single doses ranging from 3 mg to 240 mg, per the filing.
  • Multiple ascending doses tested: Multiple-dose regimens included 30 mg once daily, 30 mg twice daily, and 90 mg twice daily for 14 days, the filing reports.
  • Tolerability finding: According to the filing, izicopan "was well tolerated" at all single and multiple dose levels studied.
  • Prior announcements: The filing notes the positive results were previously announced in 2023 and 2024.

InflaRx Phase 1 Izicopan Publication: Study Design and Reported Results

InflaRx N.V. (NASDAQ:IFRX), a biopharmaceutical company headquartered in Jena, Germany, submitted a Form 6-K to the U.S. Securities and Exchange Commission on November 6, 2026. The report accompanies a press release announcing that peer-reviewed Phase 1 clinical data for izicopan, described in the filing as "the Company's orally administered, next-generation small molecule inhibitor of the C5a receptor (C5aR1)," had been published.

The publication covers results from a single ascending dose (SAD) and multiple ascending dose (MAD) study conducted in 86 healthy participants. The filing states that izicopan was well tolerated at single doses ranging from 3 mg to 240 mg, as well as at multiple-dose regimens of 30 mg once daily, 30 mg twice daily, and 90 mg twice daily, each administered over 14 days. The filing characterizes the publication as reporting on the "Safety and Pharmacokinetic/Pharmacodynamic Profile" of the compound, consistent with the press release title cited in the report.

The filing notes that the positive results from these studies were previously announced in 2023 and 2024, and that the attached press release (Exhibit 99.1) "shall not be deemed 'filed' for purposes of Section 18 of the Securities Exchange Act of 1934." The report contains forward-looking statements, which the company identifies as subject to known and unknown risks and uncertainties, and for which the company states it "assumes no obligation to update," except as required by law. The Form 6-K was signed by Niels Riedemann, Chief Executive Officer of InflaRx N.V.

What Was Disclosed

InflaRx N.V. disclosed, via a November 6, 2026 Form 6-K, the peer-reviewed publication of Phase 1 SAD and MAD data for izicopan in 86 healthy participants, covering doses from 3 mg to 240 mg (single) and multiple regimens over 14 days.