FDA Approves Phase II Study of Natrunix in Patients With Rheumatoid Arthritis

Tuesday, May 23, 2023

XBiotech Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) Division of Rheumatology to initiate a clinical phase -II study evaluating Natrunix™ in rheumatoid arthritis.

The randomized, double-blind, placebo-controlled study will evaluate the efficacy of Natrunix for the treatment of rheumatoid arthritis compared to placebo in patients who are already on stable but inadequate methotrexate (MTX) therapy. A total of 210 patients will be randomly and equally divided into three groups: two Natrunix groups with different doses and one placebo group. Change in disease severity is assessed at multiple time points using the American College of Rheumatology (ACR) grading scale. Study participants will also be assessed for reduction in pain, number of painful or swollen joints, and overall disease activity. The study is completed

Natrunix™ is a preparation containing a monoclonal antibody that is indistinguishable from the naturally occurring antibody in a healthy human. With billions of different antibodies circulating in the blood of healthy people, identifying a single antibody molecule poses a technical challenge. None of the previous antibody therapies on the market have actually been derived from a natural human antibody.

The Phase II study in rheumatoid arthritis is the culmination of XBiotech's commitment to pioneering therapies derived from natural human immunity. XBiotech's core proprietary technology enables the identification of rare antibodies in the blood of human donors. These antibodies may be used in the natural treatment of diseases such as B. the therapy candidate Natrunix for the treatment of arthritis. XBiotech also has antibodies to treat infectious diseases such as Flu, Ebola, COVID, Shingles, among others.

Natrunix specifically targets and neutralizes the neurotransmitter interleukin-1α (IL-1α). IL-1α is produced by the human body and is involved in many diseases. In chronic diseases such as rheumatoid arthritis, IL-1α may play a central role in the disease process. IL-1α may mediate synovial breakdown, bone remodeling, pain and inflammation in the rheumatoid joint.

With over 86,000 scientific manuscripts and 6,600 review articles on interleukin-1 (IL-1), this messenger substance is one of the most studied substances in medicine. There are several therapeutics on the market that target "interleukin-1" (including KINERET™, ARCALYST™ and ILARIS™). However, the term interleukin-1 actually refers to two different molecules - IL-1α and IL-1β - that are made at different times and in different places and play very different roles in disease. Importantly, Natrunix is ​​the only product candidate that exclusively targets and neutralizes the activity of IL-1α, the 'missing link', in the treatment of arthritis.

Rheumatoid arthritis currently affects one in four adults or more than 50 million people in the US, including 33% of those aged 45 to 64 and 50% of those aged 65 and over. It is expected that the number of people suffering from rheumatoid arthritis will continue to increase. The CDC projects that by 2040, 78.4 million adults in the United States will be affected by rheumatoid arthritis. In addition, an estimated 300,000 children are expected to suffer from juvenile arthritis (Arthritis Foundation, 2023). 



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