InflaRx: IDMC Recommends To Stop Vilobelimab Phase 3 Trial In Pyoderma Gangrenosum Due To Futility

(RTTNews) - InflaRx N.V. (IFRX), a German biopharmaceutical company focused on anti-inflammatory therapeutics, announced Wednesday that the Independent Data Monitoring Committee or IDMC conducting the unblinded interim analysis for the Phase 3 trial for vilobelimab in pyoderma gangrenosum or PG recommended to stop the trial due to futility.

InflaRx said it intends to discontinue further development of vilobelimab in the PG indication and to prioritize its resources on INF904. The company expects Phase 2a data readouts in chronic spontaneous urticaria or CSU and hidradenitis suppurativa or HS this summer.

The company is also considering additional cost savings and redirection of resources toward the goal of extending its existing cash runway.

The IDMC recommendation on vilobelimab in PG 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.

Niels Riedemann, Chief Executive Officer and Founder of InflaRx, said, "While the outcome is not what we had hoped it would be, InflaRx remains committed to its goal of developing new therapies for underserved patients with chronic immune-dermatological conditions, including with our oral inhibitor of C5aR, INF904, with data expected this summer."

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

GOHIBIC (vilobelimab) is an investigational drug that has not been approved by the FDA for any indication, including for the treatment of COVID-19.

The company said it will continue its support of the BARDA-funded Phase 2 clinical platform study.

In the EU, vilobelimab has been granted marketing authorization under exceptional circumstances for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome or ARDS.

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