Welcome to our dedicated page for XBiotech news (Ticker: XBIT), a resource for investors and traders seeking the latest updates and insights on XBiotech stock.
XBiotech Inc. (NASDAQ: XBIT) is a clinical-stage biopharmaceutical company based in the United States, focused on discovering and developing True Human™ monoclonal antibodies for treating a variety of diseases. Founded on pioneering technologies in antibody research, XBiotech aims to harness the body's natural immunity to combat serious illnesses.
The company's flagship product, MABp1, is a first-in-class monoclonal antibody designed to inhibit chronic inflammation, a key factor in the progression of numerous significant diseases. MABp1 has shown promising results in clinical trials for various conditions, including cancer and leukemia (Phase I), type 2 diabetes (Phase II), psoriasis (Phase II), and vascular disease (Phase II). This antibody is unique as it remains unmodified from its natural human form, which has contributed to its excellent safety and tolerability profiles in clinical trials.
Another notable product in XBiotech's pipeline is Natrunix, currently under investigation for treating rheumatoid arthritis (RA). Natrunix works by blocking interleukin-1 (IL-1), a critical component in the inflammation process that causes pain and joint destruction in RA. A recent Phase II study involving Natrunix aims to assess its efficacy in combination with methotrexate (MTX), involving approximately 210 subjects across various clinical sites in the United States. Early findings are promising, showing significant potential for improving pain, tenderness, and mobility in joints, alongside enhancing patients' quality of life.
Hutrukin is another promising candidate in XBiotech's portfolio, aimed at minimizing brain injury following ischemic stroke. The company has recently completed enrollment for a Phase I clinical study to assess the safety and pharmacokinetics of Hutrukin. This novel antibody could potentially reduce inflammatory injuries associated with reperfusion, a common issue following stroke treatments.
XBiotech's commitment to innovation extends to its biomanufacturing capabilities. The company has invested in a commercial-scale plant featuring a total bioreactor capacity of 25,000 liters, adhering to current good manufacturing practices (cGMP). These advancements enable rapid and flexible production of therapeutic antibodies, ensuring timely delivery to patients in need.
Headquartered in Austin, Texas, XBiotech leverages cutting-edge genetic engineering tools to identify rare antibodies from human donor blood. This approach has resulted in a robust pipeline of True Human™ antibody therapies that hold potential for revolutionizing treatments for oncology, inflammatory conditions, and infectious diseases. For more information, visit www.xbiotech.com.
XBiotech (NASDAQ: XBIT) announced the suspension of its rheumatology clinical program following irregularities in its Phase II study of Natrunix for Rheumatoid Arthritis. The study, which enrolled approximately 230 subjects with moderate to severe rheumatoid arthritis, failed to meet its primary endpoint of ACR20 response rate after 12 weeks. The trial evaluated Natrunix (200mg or 400mg weekly) in combination with methotrexate (MTX) against placebo with MTX.
Significant irregularities were discovered at the highest enrolling clinical sites, including multiple enrollments of the same subjects, raising concerns about data interpretation. The company has put additional planned studies in arthritis and ankylosing spondylitis on hold while evaluating these findings.
XBiotech (NASDAQ: XBIT) announced promising results from its Phase 1/2 trial for advanced pancreatic cancer treatment using Natrunix in combination with a standard chemotherapy regimen. The study, titled 1-BETTER, enrolled 65 subjects who received either the Natrunix combination or a placebo. Key findings include a 28% reduction in significant adverse events in the Natrunix group, a 33% decrease in hospitalization days, and a notable improvement in patient-reported outcomes such as reduced fatigue (22%) and pain (41%). While overall survival rates showed a trend favoring Natrunix, the small sample size led to a borderline statistical significance (p = 0.096). XBiotech emphasizes the potential of Natrunix to improve tolerability and efficacy of pancreatic cancer treatment.
XBiotech Inc. has initiated a randomized, open-label, placebo-controlled clinical study for Hutrukin, a novel therapy aimed at reducing brain injury from ischemic stroke. With over 10 million cases of ischemic strokes annually, the need for effective treatments is critical. Hutrukin seeks to mitigate reperfusion injury, a common complication following clot-removal procedures, by targeting inflammation before blood flow is restored. The Phase I study will evaluate three dosing levels for safety and pharmacokinetics, with results guiding further research phases. XBiotech leverages its proprietary True Human™ antibody technology to explore innovative treatments across various diseases.
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