XBiotech Pauses Rheumatology Program
XBiotech Pauses Rheumatology Program
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.Findings from recently completed Rheumatoid Arthritis Study raise questions
最近完成的類風溼性關節炎研究的結果引發了質疑
AUSTIN, Texas, Dec. 23, 2024 (GLOBE NEWSWIRE) -- 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.
德克薩斯州奧斯丁，2024年12月23日（全球新聞通訊）-- XBiotech（納斯達克：XBIT）今天宣佈，由於需要理解其最近完成的類風溼性關節炎II期、雙盲、安慰劑對照、隨機研究的結果，因此將暫停其在風溼病領域的臨牀計劃。該II期研究未能達到其主要終點，且存在重大不規則性，使得對研究結果的明確解釋變得困難。XBiotech原計劃在類風溼性關節炎以及其他風溼病領域（包括強直性脊柱炎）啓動額外研究，但在評估最近的發現時，這些研究目前暫停。
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.
約230名中重度類風溼性關節炎患者被納入此II期關節炎研究，該研究審查了公司的候選藥物Natrunix與甲氨蝶呤（MTX）的聯合使用。該研究的主要終點是在治療12周後美國風溼病學會（ACR）20%的反應率。還進行了各種其他風溼病評估，包括NRS-疼痛評分、關節炎關節計數、生活質量評估和安全性。研究人群按1:1:1的比例隨機分爲三組：每週200mg或400mg Natrunix與MTX聯合使用；或者每週使用安慰劑與MTX聯合使用。
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.
II期研究中的不規則性涉及登記數量最高的臨牀中心，包括多名受試者被多次錄入。雖然該研究未能滿足療效終點，但在數據分析中發現的差異表明，在解釋結果時應謹慎。研究結果仍在分析中，以更好地理解這些發現的意義，並判斷如何利用這些結果來指導Natrunix潛在的進一步風溼病研究。
About XBiotech
XBiotech 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 .
關於XBiotech
XBiotech在基於其真正人類抗體技術的治療藥物發現與開發方面處於領先地位。該公司有幾個候選產品，包括Natrunix，這些產品是從擁有對某些疾病自然免疫力的個體捐贈者那裏克隆而來的。XBiotech的總部位於奧斯丁市中心僅幾分鐘路程，包括GMP製造設施、研究和測試實驗室、傳染病研究設施、質量控制和臨牀運營。更多信息，請訪問。
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Contact
聯繫
Wenyi Wei
wwei@xbiotech.com
Tel. 737-207-4600
魏文怡
wwei@XBiotech.com
電話：737-207-4600
譯文內容由第三人軟體翻譯。