$IFRX Update on IFX-1 In June 2020, InflaRx N.V. (the “Company”) completed an end of Phase 2 meeting with the U.S. Food and Drug Administration (the “FDA”) to discuss a Phase 3 development program for the use of IFX-1 in the treatment of hidradenitis suppurativa (“HS”). During the course of the meeting, the FDA agreed to key proposals to support a BLA submission, including aspects of the Phase 3 trial design, IFX-1 dosing, target study population, and the nonclinical and clinical pharmacology packages. As part of the Phase 3 design, the Company proposed using the International Hidradenitis Suppurativa Severity Score (“IHS4”) as the primary efficacy endpoint. While the FDA did not agree that the IHS4 score is fit for purpose as a primary efficacy endpoint tool to support labeling, the FDA recommended that the Company obtain HS patient input to help determine the validity of the IHS4 score.
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