InflaRx Ends Lead Asset Development After Failed Study For Rare And Painful Skin Disease

InflaRx N.V. (NASDAQ:IFRX) on Wednesday announced that the Independent Data Monitoring Committee (IDMC) conducting the unblinded interim analysis for the Phase 3 trial for vilobelimab in pyoderma gangrenosum (PG) recommended that the trial be stopped due to futility.

Pyoderma gangrenosum is a rare, chronic skin condition characterized by painful, necrotic ulcers that often appear on the legs.

The recommendation was based on data analysis of the first 30 patients enrolled in the study, with no unexpected adverse events noted by the IDMC.

InflaRx, as the study sponsor, remains blinded to the study results.

InflaRx intends to discontinue further development of vilobelimab in the PG indication and prioritize its resources on INF904, with Phase 2a data readouts in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) anticipated this summer.

The company is also considering additional cost savings and resource redirection to extend its existing cash runway.

GOHIBIC (vilobelimab) remains available in the U.S., where it has been granted Emergency Use Authorization by the Food and Drug Administration (FDA) for COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO).

The company will continue supporting the BARDA-funded Phase 2 clinical platform study.

In the EU, GOHIBIC (vilobelimab) has been granted marketing authorization under exceptional circumstances for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of the standard of care and receiving IMV with or without ECMO.

• InflaRx is considering commercial partnering and distribution options in the EU and does not expect this approach to negatively impact its cash burn rate.

In February, InflaRx completed its underwritten public offering of 8.25 million shares at $2.00 per share and pre-funded warrants to purchase up to 6.75 million shares, raising approximately $30 million in gross proceeds.

• On March 31, 2025, cash, cash equivalents, and marketable securities totaled 65.7 million euros, including proceeds from an underwritten public offering completed in February.
• The company estimates it has sufficient funds for currently planned operations into 2027.

Price Action: At the last check on Wednesday, IFRX stock was down 52.8% to $0.86 during the premarket session.

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