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礼来IL-17A单抗ixekizumab银屑病关节炎III期成功

来源:生物谷 2015-04-21 09:47

2015年4月21日讯 /生物谷BIOON/ --美国医药巨头礼来(Eli Lilly)备受业界关注的新一代关节炎药物ixekizumab在银屑病关节炎关键III期SPIRIT-P1研究获得成功。该研究在活动性银屑病关节炎(PsA)患者中开展,调查了2种剂量皮下注射ixekizumab相对于安慰剂的疗效。数据显示,与安慰剂相比,ixekizumab 2个剂量组均有显著更高比例的患者实现ACR20缓解,达到了研究的主要终点。安全性方面,ixekizumab与之前的银屑病III期研究一致,最常见的不良反应为鼻咽炎和注射部分反应。礼来未透露SPIRIT-P1研究的详细数据,计划在即将举行的科学会议上予以公布。

目前,SPIRIT-P1研究仍在继续,以评估ixekizumab在长达3年内的长期疗效数据。另外,礼来计划在12月份启动银屑病关节炎第二个III期研究。

ixekizumab的首要疾病适应症是银屑病,在相关III期临床表现良好,在关键指标方面ixekizumab击败了安慰剂和银屑病重磅药物Enbrel。礼来已计划在本季度末向FDA提交ixekizumab治疗银屑病的新药申请(NDA)。

目前,银屑病新药研发竞争异常激烈,诺华是IL-17单抗领域的领导者,该公司IL-17单抗药物Cosentyx(secukinumab)于2015年1月获FDA批准,是全球上市的首个IL-17单抗,标志着银屑病临床治疗的重大里程碑。但分析师预计,该市场将很快迎来其他竞争产品,紧跟其后的是安进和阿斯利康开发的类似药物brodalumab,该药在银屑病和银屑病关节炎III期临床中均创下了骄人的成绩,双方已计划在今年提交brodalumab的上市申请。此外,默沙东的MK-3222及强生(JNJ)的IL-23阻断剂guselkumab均已进入III期临床开发。

与礼来一样,银屑病关节炎(PsA)是各大制药巨头争夺的第二个适应症。其中,诺华已计划在今年向FDA提交Cosentyx治疗银屑病关节炎的新适应症申请,其他巨头尚未透露各自的时间表。(生物谷Bioon.com)

英文原文:Lilly's psoriatic arthritis drug aces Phase III with a crowded market ahead

Eli Lilly's ($LLY) closely watched autoimmune treatment met its main goals in a Phase III psoriatic arthritis trial, rolling toward an FDA application and a shot at competing in a fast-crowding space.

The antibody, ixekizumab, works by blocking a cytokine called interleukin-17A, tamping down the inflammation at the heart of many autoimmune diseases. In a Phase III trial, Lilly tested two doses of the subcutaneous treatment against placebo in patients with psoriatic arthritis, and both ixekizumab groups demonstrated statistically significant improvements after 24 weeks, the company said.

On the safety side, Lilly said ixekizumab had a similar side effect profile as in earlier Phase III studies, where the most common adverse events were nasopharyngitis and injection site reaction. Lilly is disclosing only top-line data for now, saving full results for a later scientific meeting. The study will continue to evaluate ixekizumab's long-term efficacy for up to three years, Lilly said, and the company is working through a second Phase III psoriatic arthritis trial that began in December.

Ixekizumab's top target is psoriasis, against which the antibody has performed well in Phase III trials. Lilly plans to hand in an FDA application on that indication by the end of this quarter, pointing to pivotal data in which ixekizumab bested both placebo and the blockbuster Enbrel in clearing up psoriasis symptoms.

Lilly is one of many contenders in the competitive IL-17 space, led by Novartis ($NVS) and its psoriasis-treating secukinumab, approved in January as Cosentyx. Meanwhile, partners Amgen ($AMGN) and AstraZeneca ($AZN) are on pace to file their rival brodalumab this year, while Merck ($MRK) is working through Phase III with the IL-23-blocking tildrakizumab, and Johnson & Johnson ($JNJ) is doing the same for its similar guselkumab.

Like Lilly, each of the major psoriasis players is eyeing psoriatic arthritis as a secondary indication. Novartis is planning to file for approval in that disease this year, while the others are yet to disclose their timelines.

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