^ AUSTIN, Texas, Dec. 24, 2024 (GLOBE NEWSWIRE) — XBiotech (NASDAQ: XBIT) has
announced today that it is expanding its rheumatology clinical program
Illnesses stop while the company tries to monitor the results of its
recently completed double-blind, placebo-controlled, randomized
Phase II study in rheumatoid arthritis. The phase II study
failed to meet its primary endpoint due to significant irregularities
It is not possible to make clear interpretation of the results difficult. XBiotech
planned to conduct further studies on arthritis and others
rheumatological diseases, including Bechterew’s disease. These studies
However, they have been put on hold for the time being to allow for the latest research results
evaluate.
The Phase II arthritis study involved approximately 230 patients with moderate arthritis
to severe rheumatoid arthritis. In the study the
The Company’s drug candidate, Natrunix, in combination with methotrexate
(MTX) investigated. The primary endpoint of the study was the response rate
American College of Rheumatology (ACR) 20 scale after 12 weeks of treatment. It
various other rheumatological examinations were also carried out,
including NRS pain ratings, arthritic joint counts, reviews
quality of life and safety. The study population was proportional
Randomized 1:1:1 into three groups: 200 mg or 400 mg Natrunix weekly in
Combination with MTX or weekly placebo with MTX.
Irregularities in the Phase II trial affected those most heavily involved
clinical centers, including numerous patients who were admitted multiple times
became. Although the study did not meet the efficacy endpoints, the
Discrepancies found during data analysis should be interpreted with caution
of the results appear necessary. The results of the study are still being published
analyzed to better understand the impact of the results and
determine how these results serve as a guide for possible further research
rheumatological studies on Natrunix can be used.
About XBiotech
XBiotech is pioneering the discovery and development of
Therapeutics based on its True Human(TM) antibody technology. The
Company has several potential products, including Natrunix, which is from
cloned from individual donors who have natural immunity to certain
have diseases. XBiotech’s campus-based headquarters is just a few steps away
Minutes from downtown Austin and includes GMP manufacturing facilities,
Research and testing laboratories, research facilities
Infectious diseases as well as quality control and clinical processes. More
For information, visit www.xbiotech.com.
Cautionary Statement Regarding Forward-Looking Statements and Study Results
This press release contains forward-looking statements, including:
Statements on management’s assessments and expectations
significant risks and uncertainties are involved. Forward-looking
Statements are subject to inherent risks and uncertainties in their prediction
future results and conditions that could cause the
actual results may differ materially from those expressed in these forward-looking statements
Statements differ from forecasts. These risks and uncertainties
are subject to the information set out in the “Risk Factors” section in some of our
SEC reports are listed. All forward-looking statements contained herein
Press releases are only valid at the time of publication
Press release. We assume no obligation to be forward-looking
Statements made after the date of this press release based on new information,
future events or for other reasons.
contact
Wenyi Wei
[email protected] (mailto:[email protected])
Tel. 737-207-4600
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