InflaRx N.V. (IFRX) said Thursday that it has received a corrected advice letter from the U.S. Food and Drug Administration regarding its Phase III program with vilobelimab for the treatment of hidradenitis suppurativa or HS.
In Thursday pre-market trade, IFRX was trading at $2.44 up $0.26 or 11.92%.
In this corrected letter, FDA no longer recommends that the Company use the Hidradenitis Suppurativa Clinical Response Score as the primary endpoint for the chosen patient population but gives recommendations related to implementation of the modified HiSCR.
InflaRx believes that further development in hidradenitis suppurativa is feasible, following corrected advice from the FDA.
The written advice letter received in February 2022 had stated that the Agency recommended using the HiSCR as the primary endpoint in the Phase III trial, which was inconsistent with the minutes from a Type A advice meeting held between InflaRx and the FDA in the third quarter of 2021.
The company noted that it plans to update the markets on its pipeline development strategy in the second quarter of 2022.
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