XBiotech’s stock price has taken a hit after it announced a complete halt to its clinical program in rheumatological diseases while it “seeks to understand the outcome” from a Phase II study of its arthritis treatment Natrunix that failed to meet its primary endpoint.
The Austin, Texas-based company’s stock value dropped by 27% after its Phase II trial (NCT05363917) saw what the company called “substantial irregularities that make unequivocal interpretation of the findings difficult.”
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Follow-up plans to launch additional studies in arthritis alongside other areas of rheumatology, including ankylosing spondylitis, have been put on an indefinite hold. The study’s primary endpoint sought a response rate of 50 measured using the American College of Rheumatology (ACR) response scale after 12 weeks of treatment with Natrunix. The Phase II study enrolled 230 subjects with moderate to severe rheumatoid arthritis and examined Natrunix in combination with methotrexate.
However, the company says the trial was mired with issues at trial sites including some patients being enrolled multiple times prompting the company to hold back full results from the trial as it looks to see what it can salvage.
In a statement the company said: “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.”
Previously, GlobalData’s Pharmaceutical Intelligence Centre estimated that Natrunix, also known as bermekimab, was set to see global sales of $179m by the end of 2024, with that figure having been predicted to grow to $488m by the end of 2025.
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By GlobalDataGlobalData is the parent company of Clinical Trials Arena.
Elsewhere in the field of arthritis treatments, Bristol Myers Squibb has announced positive topline results from two Phase III trials evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis, hitting both endpoints. Meanwhile, Aclaris Therapeutics’ stock also took a hit after it announced that it would discontinue the development of zunsemetinib after its Phase IIb trial failed to meet its endpoints.
