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schwache IFX-1 Studiendaten in COVID-19
Inflarx diskutiert mit der FDA über das Studiendesign für eine Phase3 von IFX-1
"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. The FDA also indicated a reasonable primary endpoint would be the Hidradenitis Suppurativa Clinical Response Score 50 (“HiSCR”).
The Company is now assessing different strategies for a potential pathway to regulatory approval for IFX-1 in the United States and plans to engage with the FDA on next steps. Additionally, the Company has requested scientific advice from the European Medicines Agency about the European pathway for regulatory approval."