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InflaRx Hits New High, Awaits Phase II Data For Hidradenitis Suppurativa In Q2

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Shares of InflaRx N.V. (IFRX) have been on a roll since the beginning of this year, hitting new highs.

Germany-based InflaRx is a clinical-stage biopharmaceutical company focused on developing treatments for a wide variety of autoimmune and inflammatory diseases.

The Company's lead compound is IFX-1, a first-in-class anti-human complement factor C5a monoclonal antibody. C5a has been implicated in a number of immuno-inflammatory diseases.

IFX-1 is being explored in the indications of moderate to severe Hidradenitis Suppurativa, ANCA-associated vasculitis (AAV), and Pyoderma Gangraenosum.

Hidradenitis Suppurativa

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.

ANCA-associated Vasculitis

ANCA-associated vasculitis or AAV is a rare and life-threatening autoimmune disease, affecting approximately 40,000 and 75,000 patients in the United States and Europe, respectively.

Glucocorticoids, Cyclophosphamide, and Rituxan are of the some commonly used treatments for AAV.

Pyoderma Gangraenosum

Pyoderma Gangraenosum is a debilitating, rare autoimmune disease marked by large, painful ulcers.

Glucocorticoids like Prednisone, immunosuppressants such as Azathioprine, Mycophenolate, Cyclophosphamide, Chlorambucil, and Tacrolimus, and TNF inhibitors such as Remicade, Humira, and Enbrel are some of the treatments for pyoderma gangrenosum.

It is estimated that up to 50,000 patients in the US and Europe are affected by this disease.

Clinical Trial Status of IFX-1

IFX-1 is under a phase IIb study in patients with moderate or severe Hidradenitis Suppurativa, dubbed SHINE. The study, designed to enroll 175 participants, completed patient enrollment last November.

The primary endpoint is a dose response signal, assessed by the Hidradenitis Suppurativa Clinical Response (HiSCR) score, at week 16. Additional objectives include the evaluation of safety and tolerability of IFX-1, as well as an assessment of additional efficacy and patient-reported outcome parameters.

IFX-1 is also under a phase II study in patients with ANCA-associated vasculitis (AAV). This study is designed to enroll approximately 36 patients.

A phase IIa clinical trial evaluating IFX-1 in Pyoderma Gangraenosum was initiated as recently as February of this year. This study is designed to enroll 12 patients with moderate to severe Pyoderma Gangraenosum.

Near-term Catalyst

The top-line results from the SHINE study, i.e., the phase IIb trial of IFX-1 in patients with moderate or severe Hidradenitis Suppurativa, are expected this quarter (Q2, 2019).

Cash Position

As of December 31, 2018, InflaRx had cash and cash equivalents and securities and other investments of €156.6 million.

IFRX Then and Now

IFRX was trading around $32.00 when it featured in our "In the Spotlight" column on February 22, 2018. The stock touched an all-time high of $52.10 in intraday trading yesterday (Apr.22), before closing at $51.28. The all-time high stock price reflects a gain of nearly 63% from our published price.

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