FDA Approves XBiotech’s IND in Rheumatology
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 22% over the
next 8 years—affecting 67 million persons in the US by 2030 (The
National Arthritis Data Workgroup). The most common form of
arthritis, osteoarthritis, currently affects 32.5 million people,
including two-thirds of persons living with obesity (CDC 2021).
About 300,000 children also suffer from rheumatic disease
(Pediatric Orthopaedic Society of North America, 2021). XBiotech
believes that Natrunix has the potential to treat all these forms
of joint disease.
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
AntibodiesXBiotech’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
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