Potential New Lupus Treatment Effectively Reduced Disease Activity in Phase III Trial

阿斯利康红斑狼疮药物anifrolumab第二个III期试验达到主要终点

2019-08-30 19:00:00 BioSpace

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The Lupus Research Alliance is excited to share the good news that a potential new medicine for lupus, anifrolumab, reduced disease activity versus placebo in a second Phase III study. Anifrolumab is a therapeutic antibody that blocks type I interferons, a molecule that promotes lupus inflammation. Over 15 studies funded by the Lupus Research Alliance over the past decade into the role of type I interferons were pivotal to the eventual development of anifrolumab. Called TULIP 2, the one-year pivotal trial measured disease activity using a well-established evaluation tool called the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA).  To meet the primary endpoint defined as a statistically significant and meaningful reduction in disease activity, BICLA requires improvement in organs affected by lupus with no new flares. A Phase III trial presents the data the U.S. Food and Drug Administration uses to decide whether or not to approve a new medicine.i As noted in the press release issued today by study sponsor AstraZeneca, "TULIP 2 was the second Phase III trial designed to assess the safety and efficacy of anifrolumab as a treatment for adults with moderate-to-severe SLE. The positive BICLA response in TULIP 2 was consistent with a pre-specified analysis of the previous Phase III TULIP 1 trial, which did not meet its primary endpoint SLE Responder Index 4 (SRI4)." This is a different composite endpoint than BICLA. TULIP 2 tested anifrolumab at a dose of 300 mg while the TULIP 1 tested anifrolumab at both 150 and 300 mg doses. "It is tremendously gratifying to learn of this important success," commented Dr. Mary Crow, Co-chair of the Lupus Research Alliance Scientific Advisory Board (SAB) and Physician-in-Chief/Chair of Department of Medicine at Hospital for Special Surgery and Chief of Rheumatology at HSS and NewYork-Presbyterian/Weill Cornell Medical Center.  "The Lupus Research Alliance has made significant investments in research focused on the role of type I interferons in lupus, and I am personally very excited given my own research in this area." Lupus Research Alliance SAB Co-chair and Professor of Medicine at Weill Cornell Medicine Dr. Gary Koretzky noted, "The study is very encouraging and is a great example of how fundamental biologic discoveries inform clinical problems, taking many years of painstaking work to fruition." Lupus Research Alliance President and CEO Kenneth M. Farber commented, "These positive results from a pivotal Phase III trial are very hopeful for people with lupus who have waited years for desperately needed new treatment options.  We look forward to seeing the full results of the study and further progress in evaluating anifrolumab as a potential therapy." The principal investigator of the study, Professor Eric F. Morand, Monash University, Australia is a past winner of the Lupus Research Alliance Distinguished Innovator Award which provides outstanding scientists with substantial support to conduct novel research into the fundamental causes of systemic lupus erythematosus. About Lupus Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. More than 90% of people with lupus are women; lupus most often strikes during the childbearing years of 15-45. African Americans, Latinx, Asians and Native Americans are two to three times at greater risk than Caucasians. In lupus, the immune system, which is designed to protect against infection, creates antibodies that can attack any part of the body including the kidneys, brain, heart, lungs, blood, skin, and joints. About the Lupus Research Alliance The Lupus Research Alliance aims to transform treatment while advancing toward a cure by funding the most innovative lupus research in the world. The organization's stringent peer review grant process fosters diverse scientific talent who are driving discovery toward better diagnostics, improved treatments and ultimately a cure for lupus.  Because the Lupus Research Alliance's Board of Directors fund all administrative and fundraising costs, 100% of all donations goes to support lupus research programs.
Lupus 研究联盟很高兴与大家分享一个好消息,即在第二期 III 期研究中,一种潜在的治疗狼疮的新药,安非洛布,减少了疾病活动相对于安慰剂。Aniblumb 是一种治疗抗体,阻断 I 型干扰素,一种促进狼疮炎症的分子。在过去十年里,由卢普斯研究联盟资助的超过15项研究成为 I 型干扰素的作用,是最终发展苯胺类药物的关键。 这项为期一年的关键试验名为 TULIP2,它使用一种成熟的评估工具,名为“不列颠群岛狼疮评估小组”,基于综合狼疮评估( BICL )。为了满足主要终点定义为统计上显著和有意义的减少疾病活动, BICL 要求改善器官受狼疮影响没有新的耀斑。 第三阶段试验提供了美国食品药品监督管理局(Food and Drug Administration)用来决定是否批准一种新药的数据。i 正如研究赞助商阿斯利康(AstraZeneca)今天发布的新闻稿所指出的,“ TULIP2是第二个 III 期试验,旨在评估安非洛单抗作为治疗中度至重度 SLE 成人的安全性和有效性。TULIP2中的 BICL 阳性反应与先前的第三阶段 TULIP 1试验的预先指定分析一致,该试验未达到其主要终点 SLE 应答指标4( SRI4)。这是一个不同于 BICL 的复合端点。 TULIP2在300毫克的剂量下检测安非洛伦,而 TULIP1在150和300毫克的剂量下检测安非洛伦。 Lupus 研究联盟科学咨询委员会( SAB )联合主席、特殊外科医院内科主任/主任兼 HSS 和纽约长老会/ Weill Cornell 医疗中心风湿病学主任 Mary Crow 博士评论说:“了解这一重要的成功令人非常高兴。”Lupus 研究联盟对研究重点是 I 型干扰素在狼疮中的作用进行了大量的投资,我个人对这一领域的研究感到非常兴奋。 Lupus Research Alliance SAB 联合主席、 Weill Cornell Medicine 的医学教授 Gary Koretzky 博士指出:“这项研究非常鼓舞人心,也是一个很好的例子,说明基本的生物学发现是如何影响临床问题的,花了多年的努力才取得成果的。” Lupus Research Alliance 总裁兼首席执行官 KennethM.Farber 评论道:“关键的 III 期试验的积极结果对于那些等待了多年的迫切需要的新治疗方案的狼疮患者是非常有希望的。我们期待看到这项研究的全部结果,并期待在评估安非洛单抗作为一种潜在疗法方面取得进一步进展。 这项研究的主要研究者,澳大利亚莫纳什大学的 Eric F . Morand 教授是卢普斯研究联盟杰出创新者奖的过去获奖者,该奖项为杰出的科学家提供了实质性的支持,对系统性红斑狼疮的根本原因进行新的研究。 关于狼疮 狼疮是一种慢性、复杂的自身免疫性疾病,影响着全世界数百万人。超过90%的狼疮患者是女性;狼疮最常发生在生育15-45岁。非洲裔美国人、拉丁裔美国人、亚洲人和土著美国人的风险是白人的2到3倍。在狼疮,免疫系统,旨在防止感染,创造抗体,可以攻击身体的任何部分,包括肾脏,大脑,心脏,肺,血液,皮肤和关节。 关于卢普斯研究联盟 Lupus 研究联盟旨在通过资助世界上最具创新性的狼疮研究来改变治疗方法,同时向治愈方法迈进。该组织严格的同行评审拨款程序培养了多样化的科学人才,他们正在推动发现更好的诊断,改善治疗,并最终治愈狼疮。由于狼疮研究联盟董事会资助所有的行政和筹款费用,100%的捐款都用于支持狼疮研究计划。

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