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InflaRx launches late-stage study of IFX-1 in COVID-19 induced pneumonia

September 14, 2020

InflaRx (NASDAQ:IFRX) has commenced global Phase 3 part of its Phase 2/3 trial with IFX-1 in severe COVID-19 induced pneumonia with the initiation of the first site in the Netherlands. Also the German regulatory authority, has approved the Phase 3 trial.

The 360-subject study’s primary endpoint will be 28-day all-cause mortality; key secondary endpoints will include assessment of organ support and disease improvement.

An interim analysis is planned after enrollment of 180 patients, with a potential for an early stop for efficacy or futility.

In June, the company reported no difference in the change from baseline to day 5 in oxygenation index between the IFX-1 cohort and those receiving best supportive care alone, the primary endpoint (with additional parameters until day 28).

IFX-1 is a monoclonal anti-human complement factor C5a antibody designed to induce an anti-inflammatory response by blocking the biological activity of C5a.

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