XBiotech Pauses Rheumatology program
December 23 2024 - 9:00AM
XBiotech (NASDAQ: XBIT) announced today data that it is
halting its clinical program in rheumatological disease while it
seeks to understand the outcome from its recently completed Phase
II, Double-Blind, Placebo-Controlled, Randomized study in
Rheumatoid Arthritis. The Phase II study failed to meet its primary
endpoint amid substantial irregularities that make unequivocal
interpretation of the findings difficult. XBiotech was planning
launch of additional studies in arthritis as well as other areas of
rheumatology, including ankylosing spondylitis, which are now on
hold while recent findings are evaluated.
About 230 subjects with moderate to severe rheumatoid arthritis
were enrolled into the Phase II arthritis study, which examined the
Company’s candidate drug, Natrunix, in combination with
methotrexate (MTX). The study’s primary endpoint was the American
College of Rheumatology (ACR) 20 response rate after 12 weeks of
treatment. Various other rheumatological assessments were also
performed, including NRS-pain scores, arthritic joint counts,
quality of life assessments, and safety. The study population was
randomized into three groups in a 1:1:1 ratio: 200 mg or 400mg
Natrunix weekly in combination with MTX; or placebo weekly with
MTX.
Irregularities in the Phase II study involved the highest
enrolling clinical sites, including numerous subjects being
enrolled multiple times. Although the study did not meet efficacy
endpoints, discrepancies found during data analysis suggest caution
in interpreting results. Findings of the study are still being
analysed in order to better understand the implications of the
findings and determine how these results can be used to guide
potential further rheumatology studies for Natrunix.
About XBiotechXBiotech is
pioneering the discovery and development of therapeutics based on
its True Human™ antibody technology. The Company has several
candidate products including Natrunix, which are cloned from
individual donors who possess natural immunity against certain
diseases. Located just minutes from downtown Austin, the XBiotech
campus headquarters includes GMP manufacturing facilities, research
and testing laboratories, infectious disease research facilities,
quality control and clinical operations. For more information,
visit www.xbiotech.com.
Cautionary Note on Forward-Looking Statements and Study
ResultsThis press release contains forward-looking
statements, including declarations regarding management's beliefs
and expectations that involve substantial risks and uncertainties.
Forward-looking statements are subject to inherent risks and
uncertainties in predicting future results and conditions that
could cause the actual results to differ materially from those
projected in these forward-looking statements. These risks and
uncertainties are subject to the disclosures set forth in the "Risk
Factors" section of certain of our SEC filings. Any forward-looking
statements that we make in this press release speak only as of the
date of this press release. We assume no obligation to update our
forward-looking statements whether as a result of new information,
future events or otherwise, after the date of this press
release.
Contact
Wenyi Weiwwei@xbiotech.comTel.
737-207-4600
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