FDA Approves XBiotech’s IND in Rheumatology
XBiotech Inc. (NASDAQ: XBIT) has received FDA authorization to initiate clinical development for Natrunix, its novel True Human™ antibody therapy targeting rheumatological diseases. This breakthrough therapy aims to treat inflammatory joint diseases, including osteoarthritis and rheumatoid arthritis (RA), without causing general immunosuppression. With an increasing number of patients diagnosed—projected to rise to 67 million in the U.S. by 2030—Natrunix's Phase I study will begin with dosing for subcutaneous injections, followed by Phase II studies in RA.
- FDA authorized clinical development of Natrunix, indicating regulatory support.
- Natrunix targets a large and growing market, with 67 million projected cases of rheumatological disease by 2030.
- No expected serious side effects from Natrunix, which could enhance its market adoption.
- None.
Launching Novel True Human Antibody Therapy Natrunix™ to Treat Rheumatology
AUSTIN, Texas, Dec. 13, 2021 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) today reports that the FDA’s Division of Rheumatology has authorized the Company to commence clinical development of Natrunix, the Company’s novel True Human™ antibody candidate therapy for treating rheumatological disease. The authorization, granted based on the Company’s investigational new drug (IND) application, allows the company to begin clinical development in rheumatology. Natrunix is a new drug, discovered and manufactured at XBiotech’s research and development headquarters in Austin, Texas. The Company believes Natrunix holds promise as a breakthrough therapy for the treatment of inflammatory joint diseases, including osteoarthritis and rheumatoid arthritis (RA).
Natrunix potently and selectively blocks inflammation that affects the joints and is not expected to cause general immunosuppression or have any other serious side effects.
Safe and effective treatments for arthritic disease is needed: one-third of adults 45-64 years old and half over 65 years of age—or about 53 million people in the United States—are currently diagnosed with rheumatological disease. And the number of persons afflicted is expected to increase rapidly—rising by
With IND approval, the Company will first launch Natrunix in a Phase I study to evaluate dosing for subcutaneous injections. Once preliminary dosing has been established, the Company plans to proceed with Phase II studies in RA.
Haritha Pallapotu, Director of Regulatory Affairs, stated, “New therapies are needed for patients with RA—especially those that reduce disease symptoms without diminishing quality of life. Natrunix is being developed to address major rheumatological diseases, and this approved IND provides the path. We believe the True Human antibody therapeutic will be a uniquely effective and safe treatment in rheumatology.”
About True Human™ Therapeutic Antibodies
XBiotech’s True Human™ antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human™ antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.
About XBiotech
XBiotech is a fully integrated global biosciences company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies based on its True Human™ proprietary technology. XBiotech currently is advancing a robust pipeline of antibody therapies to redefine the standards of care in oncology, inflammatory conditions and infectious diseases. Headquartered in Austin, Texas, XBiotech is also leading the development of innovative biotech manufacturing technologies designed to more rapidly, cost-effectively and flexibly produce therapies urgently needed by patients worldwide. For more information, visit www.xbiotech.com.
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Contact
Kaitlyn Hopkins
khopkins@xbiotech.com
Tel. 737-207-4600
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