By Chris Wack
XBiotech shares were halted at $6.49 in premarket trading Monday after the company said it is halting its clinical program in rheumatological disease while it studies the outcome from its recently completed study in rheumatoid arthritis.
The therapeutics company said the Phase 2 study of its candidate drug Natrunix failed to meet its primary endpoint amid substantial irregularities that make unequivocal interpretation of the findings difficult.
The study's primary endpoint was the American College of Rheumatology 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.
Irregularities in the study involved the highest enrolling clinical sites, including numerous subjects being enrolled multiple times.
XBiotech said the discrepancies found during data analysis suggest caution in interpreting results. The company is still studying the findings, 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.
XBiotech was planning the 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.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
December 23, 2024 09:21 ET (14:21 GMT)
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