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默沙东屋尘螨抗过敏药MK-8237显著改善患者症状

  1. MK-8237
  2. 屋尘螨
  3. 抗过敏免疫疗法
  4. 舌下含片
  5. 默沙东

来源:生物谷 2014-03-06 09:06

默沙东屋尘螨抗过敏舌下免疫含片MK-8237显著减少患者鼻部症状,这是该公司开发的第3个舌下免疫含片。

2014年3月5日讯 /生物谷BIOON/ --根据3月4日美国过敏、哮喘和免疫学会(AAAAI)2014年会,一项II期临床数据显示,默沙东(Merck & Co)开发用于治疗屋尘螨(house dust mites)过敏的免疫疗法MK-8237,显著减少了患者的鼻部症状,如打喷嚏和鼻塞。

该项研究表明,经24周治疗后,与安慰剂相比,高剂量和低剂量MK-8237分别使鼻部症状减少了49%和27%,数据具有统计学显著差异。

MK-8237是一种每日一次的舌下含片,是默沙东开发的第3个口服抗过敏免疫疗法。目前,默沙东及合作伙伴ALK Abello正在等待FDA对提摩西草抗过敏舌下免疫含片和豚草抗过敏舌下免疫含片的审查决定。

随着时间的推移,抗过敏舌下免疫含片能够训练机体免疫系统,停止对所接触免疫原的异常反应。默沙东称,目前正在为MK-8237的一项大型关键性III期试验招募患者,该公司预计于明年完成该项研究。

注:屋尘螨(house dust mites)属于蜘蛛纲动物,只有0.1-0.5mm 大小。主要孳生于卧室内的枕头、褥被、软垫和家具中,以人体身上脱落下来的皮屑为食饵。对人体可诱发尘螨过敏,常见临床表现主要为哮喘和过敏性鼻炎。(生物谷Bioon.com)

英文原文:Merck says dust mite allergy drug reduces symptoms in midstage study

(Reuters) - An immunotherapy pill to treat an allergy to house dust mites being tested by Merck & Co significantly reduced common nasal symptoms, such as sneezing and stuffy nose, according to data from a midstage clinical trial, the company said on Tuesday.

The drug, MK-8237, reduced nasal symptoms by 49 percent at the higher tested dose and 27 percent at the lower dose compared with a placebo after 24 weeks of treatment. The results, which were deemed to be statistically significant, were presented on Tuesday at the American Academy of Allergy, Asthma and Immunology (AAAAI) meeting in San Diego.

MK-8237, a once-a-day tablet designed to dissolve under the tongue, is the third oral allergy immunotherapy treatment being developed by Merck.

The U.S. drugmaker and its Danish allergy development partner ALK Abello are awaiting U.S. approval decisions likely this year for sublingual tablets that treat grass and ragweed allergies that would be alternatives to regular allergy shots at a doctor's office.

Over time, the drugs train the immune system to stop reacting abnormally to exposure to allergens.

The primary goal of the 124-patient study was a significant reduction at week 24 in average total nasal symptom score (TNSS) reported over the last four hours of a six-hour session in a special room where they were exposed to enough dust mites to set off allergic reactions. TNSS was comprised of itchy nose, blocked nose, runny nose and sneezing.

A secondary goal combined TNSS results at 24 weeks with a measure of ocular symptoms, such as red, itchy or watery eyes. By that measure, the higher dose of the Merck drug reduced symptoms by 52 percent compared with placebo and by 29 percent for the lower dose. The reduction in eye symptoms alone was as high as 68 percent, Merck said.

"We had not expected to see such pronounced effects on both nasal and ocular symptoms with this product, so we are very encouraged by this data," Dr. Hendrik Nolte, clinical leader of Merck's allergy immunotherapy program who presented the data at the meeting, said in a telephone interview.

No serious adverse side effects were reported by patients in the study. The most common side effects, deemed to be mild to moderate, included throat irritation, mouth edema and lip swelling.

Merck said it is recruiting patients for a large, pivotal Phase III trial of the dust mite allergy treatment that it hopes to complete next year.

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