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勃林格银屑病新药II期临床击败强生重磅药物Stelara

2015-6-17 09:41| 发布者: 管理员| 查看: 1720| 评论: 0|原作者: 康皮

摘要: 来源:生物谷 2015-03-24 09:13 2015年3月24日讯 /生物谷BIOON/ --勃林格殷格翰(BI)近日首次公布实验性银屑病药物BI 655066一项头对头II期临床数据。该研究在中度至重度斑块型银屑病患者中开展,将BI 6 ...



2015年3月24日讯 /生物谷BIOON/ --勃林格殷格翰(BI)近日首次公布实验性银屑病药物BI 655066一项头对头II期临床数据。该研究在中度至重度斑块型银屑病患者中开展,将BI 655066与强生重磅产品Stelara(ustekinumab)进行了对比。
数据显示,BI 655066疗效显著优于Stelara。经过12周治疗后,BI 655066治疗组实现清洁或几乎清洁皮肤(90%皮肤清除率,PASI90)的患者比例接近Stelara治疗组的2倍(77.1% vs 40%)。次要终点方面,采用静态医师整体评估(sPGA),BI 655066治疗组实现PASI90的患者比例为90%,Stelara治疗组比例为 67.5%。此外,BI 655066治疗组实现完全清洁皮肤(PASI 100)的患者比例是Stelara治疗组的2倍多(46% vs 17.5%)。安全性和耐受性方面BI 655066与Stelara相似。
相关数据已于近日提交至在美国加利福尼亚举行的第73届美国皮肤病学会(AAD)年会上。根据该项头对头II期研究的积极数据,勃林格已计划启动III期临床项目,进一步调查BI 655066的临床潜力。
研究人员表示,该项研究结果令人折服。当前,Stelara是一种广泛认可的中重度银屑病临床标准治疗药物,该药属于IL-12和IL-23抑制剂类药物,在2014年的销售额高达13亿美元。而此次头对头研究中,BI 655066表现出了比Stelara更优越更明显的皮肤改善,尤其令人鼓舞的是,该研究将PASI90定为新的治疗目标,而PASI90是比PASI75更高的皮肤清除标准。
需要指出的是,在银屑病治疗领域,诺华研发的全球首个白介素17(IL-17)单抗药物Cosentyx在今年1月获得美欧2大市场批准上市,该药的获批标志着银屑病临床治疗的重大里程碑。在III期临床项目中,Cosentyx疗效击败市场中的2种重磅药物:强生的Stelara和安进的Enbrel。
银屑病是一种慢性免疫系统疾病,尽管该病的确切病因尚未明确,但目前已知该病与过度活跃的免疫系统活动相关,驱动皮肤细胞以一种异常快的速率生长(高达10倍)进而堆积形成红色发痒的皮肤片状斑块。这种异常的免疫反应由免疫细胞及释放的细胞因子驱动。白介素23(IL-23)是其中的关键驱动因子之一。IL-23激活并维持多种免疫细胞,同时导致其他细胞因子的产生,包括IL-17和IL-22,这2种细胞因子对诱导皮肤炎症具有直接的作用。而BI 655066能够选择性阻断IL-23,从而有助于防止IL-17和IL-22的产生。(生物谷Bioon.com)
英文原文:Boehringer Ingelheim’s investigational biologic cleared skin better than ustekinumab in head-to-head Phase II psoriasis study  
Nearly double the percentage of patients on BI 655066 with clear or almost clear skin (PASI 90) after 12 weeks vs. ustekinumab
BI 655066 selectively blocks IL-23, a key protein involved in psoriatic skin inflammation
SAN FRANCISCO, Calif. - Ingelheim, Germany,  March 20, 2015 – For the first time, Boehringer Ingelheim announced Phase II data from its investigational compound BI 655066*. Nearly double the percentage of patients with moderate-to-severe plaque psoriasis achieved clear or almost clear skin (described as PASI 90) after 12 weeks of treatment with BI 655066 compared to ustekinumab (77.1% versus 40% of patients).1 The study (NCT02054481) investigated the efficacy and safety of the new compound versus the commonly used psoriasis treatment, ustekinumab.1 BI 655066 had similar safety and tolerability to ustekinumab.1 The new data were presented today in a late-breaker session at the 73rd Annual Meeting of the American Academy of Dermatology in San Francisco, California.
"“The results of this study are compelling. Patients showed significant skin improvement with BI 655066 compared to ustekinumab, a widely acknowledged and accepted standard of treatment for moderate-to-severe psoriasis," commented K. Alexander Papp, MD, PhD, President of Probity Medical Research, Waterloo, Ontario, Canada. "These results are particularly encouraging given the study focused on a new treatment goal of PASI 90. The results showed that more patients treated with BI 655066 reached this rigorous primary endpoint. Furthermore, we saw that patients continued to achieve clear or almost clear skin beyond week 12. Achieving clear or almost clear skin can make a real difference to patients as they have to deal with the daily impact of psoriasis."
In this primary Phase II analysis, the selective IL-23 inhibitor BI 655066 was superior to ustekinumab, an IL-12/23 inhibitor (PASI 90 77.1% vs. 40%).1 Using sPGA (static Physician Global Assessment) as a secondary outcome measure to determine psoriasis severity, 90% of patients in the study given BI 655066 had clear or almost clear skin compared with 67.5% for ustekinumab.1 These efficacy analyses were based on pooled dose results for BI 655066 of 90 and 180mg.1 In addition, results showed that more than double the percentage of psoriasis patients on BI 655066 achieved completely clear skin (PASI 100) after 12 weeks (46% of patients on BI 655066 compared to 17.5% patients on ustekinumab). The most commonly reported side-effects in the trial were a runny nose and sore throat (nasopharyngitis) and headache.1
In the study, 166 patients were randomly assigned to one of three dose groups of BI 655066 (18, 90 or 180 mg) or ustekinumab (one of two doses according to its label).1 All study treatments were given as an injection under the skin.1
"These Phase II study results in psoriasis mark a major milestone in our growing immunology research and clinical program," said Dr Steven Padula, Therapeutic Area Head Medicine Immunology at Boehringer Ingelheim. "We are planning Phase III studies in psoriasis and are actively recruiting clinical trial investigators. Our ambition is to bring forward ground breaking new medicines to transform the lives of patients with immune diseases."
Supporting Phase I data was published online in The Journal of Allergy and Clinical Immunology on March 12, 2015: http://www.jacionline.org/article/S0091-6749(15)00108-6/abstract
Psoriasis is a chronic immune system disease.2 While the exact cause of psoriasis is unknown, it is associated with an overactive immune system that drives skin cells to grow at an abnormally fast rate (up to 10x) and accumulate to form itchy, red, flaky skin plaques.2 This abnormal immune response is driven by immune cells and proteins that are released, known as cytokines.2 A cytokine called interleukin-23 (IL-23) is one of the key drivers of psoriasis. IL-23 activates and maintains several immune cells and leads to the production of other cytokines including IL-17 and IL-22. IL-17 and IL-22 have direct effects on the skin inducing skin inflammation that contributes to appearance or flare up of psoriasis. BI 655066 has been specifically designed to target a key part of the IL-23 protein known as the p19 subunit that selectively blocks IL-23 and thus helps prevent the production of IL-17 and IL-22.

http://news.bioon.com/article/6667307.html

来源:生物谷 2015-03-24 09:13


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