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InflaRx Shines On Data From Open Label Extension Part Of IFX-1 Study

Shares of InflaRx (IFRX) climbed more than 30% in extended trading on Wednesday, following positive results of the open-label extension part of the Company's international phase IIb study of IFX-1 in patients with moderate to severe Hidradenitis Suppurativa, dubbed SHINE.

Hidradenitis Suppurativa, or HS, also called acne inversa, is a disease that usually begins as pimple-like bumps on the skin. It is more common on the underarms and groin. Over time, these pimple-like bumps can grow deep into the skin and become painful. (Source: American Academy of Dermatology).

The standard of care for HS patients includes topical, oral or intravenous antibiotic treatment, which often only provides temporary symptomatic relief. In some cases, patients also undergo surgery. AbbVie's (ABBV) Humira is the first and only FDA-approved treatment for moderate to severe Hidradenitis Suppurativa in adults.

In the United States, up to 200,000 patients are affected yearly with moderate to severe HS, and the disease has an orphan designation.

The top-line results of the international SHINE phase IIb study were reported in June of this year, with the trial failing to achieve the primary endpoint of a dose-response signal, assessed by the Hidradenitis Suppurativa Clinical Response (HiSCR) score at week 16.

A total of 156 patients entered the 6-month open-label extension (OLE) period upon completion of week 16 of the recently reported SHINE study. Of the 156 patients who entered the OLE part, 72 were in the Responder Group and 84 in the Non-responder Group. A total of 122 of the 156 patients completed the OLE phase.

The endpoint focus for the OLE part of the study was the HiSCR response rate at week 40. According to the Company, 70.6% of the Responder Group maintained their HiSCR response during the OLE, and 41.8% of the Non-responder Group became responders at week 40.

About 56.3% of all patients who completed the OLE were HiSCR responders at the end of the 9-month treatment period, noted the Company.

InflaRx plans to discuss the SHINE study data with regulatory authorities.

IFRX closed Wednesday's trading at $2.59, down 3%. In after-hours, the stock was up 32.43% to $3.43.

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