2013年8月24日讯 --葛兰素史克（GSK）8月23日宣布，实验性药物vercirnon III期项目中首个研究（SHIELD-1）未达到主要终点。该项研究在中度至重度克罗恩病（Crohn's disease，CD）成人患者中开展，调查了vercirnon诱导临床反应和临床缓解的有效性和安全性。该项研究未能达到改善临床反应的主要终点，也未能达到改善临床缓解的关键次要终点。

研究中，各治疗组严重不良事件发生率和不良事件退出治疗率相似，但总体不良事件发生率呈现剂量依赖性增加趋势。GSK将对SHIED-1研究的数据进行进一步的审查，研究的完整数据，将提交至即将举行的科学会议及同行评议的科学期刊。vercirnon III期临床项目中，其他正在开展的III期临床试验的新患者招募和给药试验已全部暂停。

SHIED-1是一项随机、双盲、安慰剂对照III期研究，在608例经常规治疗无法充分控制病情（包括对TNF-α拮抗剂无响应）的中度至重度活动性克罗恩病成人患者中，评估了2种剂量（每日1次500mg，每日2次500mg）vercirnon相对于安慰剂的疗效和安全性，主要终点为实现临床反应的患者比例，关键次要终点为临床缓解。

Vercirnon是一种实验性非生物制剂、口服CCR9受体拮抗剂，由GSK于2010年1月从ChemoCentryx公司授权获得。目前正开发用于炎症性肠道疾病（如克罗恩病）的治疗。

vercirnon III期临床开发项目，包含4个III期临床试验（SHIELD-1, SHIELD-2, SHIELD-3，SHIELD-4），旨在评估vercirnon诱导临床反应和临床缓解的有效性、安全性及维持缓解的作用。

GSK announces phase III study of vercirnon in patients with moderate-to-severe Crohn’s disease did not meet its primary endpoint

GlaxoSmithKline (GSK) announced today that the first of four Phase III studies, the SHIELD-1 study, investigating vercirnon - an investigational CCR9 antagonist - in adult patients with moderately-to-severely active Crohn’s disease did not achieve the primary endpoint of improvement in clinical response and the key secondary endpoint of clinical remission.The rates of serious adverse events and withdrawals due to adverse events were similar among the treatment groups, but there was a trend for dose-dependent increases in overall adverse event rates. GSK will continue to explore the safety and efficacy results to inform decisions about the clinical development programme for vercirnon. New recruitment and dosing in the ongoing clinical programme has been suspended pending further review of the SHIELD-1 results.“The results from the SHIELD-1 study are clearly disappointing but we are committed to further explore the data to determine the way forward to help patients with this chronic debilitating gastrointestinal disease,” commented Paul-Peter Tak, M.D., Ph.D., Senior Vice President, GSK Immuno-inflammation R&D.Vercirnon is not approved or licensed for use anywhere in the world. The full results from the SHIELD-1 study will be submitted to a forthcoming scientific congress and peer-reviewed scientific journal.About SHIELD-1 study

SHIELD-1 is a randomised, double-blind, placebo-controlled study that evaluated the efficacy and safety of two doses (500 mg once daily and 500 mg twice daily) of vercirnon compared to placebo over 12 weeks in 608 adult patients with moderately-to-severely active Crohn's disease.The study was conducted in patients who were not adequately controlled with conventional therapy, and included patients who did not respond to tumour necrosis factor-alpha (TNF-α) antagonists.The primary endpoint was the proportion of patients achieving clinical response, defined as a decrease in Crohn's Disease Activity Index (CDAI) score of at least 100 points at 12 weeks. Clinical remission (CDAI score less than 150 points) at 12 weeks was evaluated as a key secondary endpoint.The study was conducted at over 200 study centres globally.About vercirnon (GSK1605786)

Vercirnon is an investigational non-biologic, orally administered CCR9 antagonist which GSK licensed from ChemoCentryx in January 2010.About Phase III clinical programme

The Phase III clinical development programme for vercirnon comprises four studies (SHIELD-1, SHIELD-2, SHIELD-3 and SHIELD-4) designed to evaluate the efficacy and safety of vercirnon for inducing a clinical response and remission (reduction or disappearance of symptoms) and maintaining remission in over 2,500 patients with moderately-to-severely active Crohn’s disease.About Crohn’s disease

Crohn's disease is a chronic inflammatory condition of the digestive tract. It most commonly affects the lower part of the gastrointestinal tract, causing symptoms such as persistent diarrhoea, abdominal pain, fever, rectal bleeding, loss of appetite and weight loss. It is estimated that the disease affects over 600,000 patients in North America and over 800,000 patients in Europe. Patients suffer periods of flare-ups characterised by intense symptoms, interspersed with periods of relative remission where symptoms decrease or disappear. Current treatment options include corticosteroids, immunomodulators or biologics.  Following diagnosis, patients frequently need to continue therapy lifelong, often layering additional therapies as flare-ups recur or persist. There is currently no curative medical therapy and many patients progress to surgery when treatments no longer control the symptoms.GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

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