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Alzheimer Res Ther:迫切需要开发阿尔茨海默氏症药物

来源:生物谷 2014-07-06 19:36

2014年7月6日讯 /生物谷BIOON/--近日,研究人员第一次对阿尔茨海默氏病(AD)有关的临床试验进行了分析,提示迫切需要增加开发AD药物,并开发出新疗法。研究论文发表在Alzheimer's Research & Therapy杂志上。

综观所有正在进行中的临床试验所示:针对阿尔茨海默氏病所开发的药物数量相对较少,在2002-2012十年间,AD药物研发失败率是99.6%。自2009年以来,药物开发数量一直在下降。

主要研究人员Jeffrey L. Cummings医师表示:我们的目标是研究历史趋势,以帮助理解为什么老年痴呆症的药物开发经常失败,全世界范围内,估计有4400万人患此疾病,研究表明,鉴于问题的严重性,阿尔茨海默氏病药物开发的生态系统需要更多的关注和支持。

使用ClinicalTrials.gov(政府网站,记录了所有正在进行的临床试验),Cummings博士以及Kate Zhong医师等人全面分析检查自2002年以来,所有的临床试验。

通过分析完成和正在进行的临床试验,以及目前候选的活性化合物,能够提供深入观察药物开发的纵向趋势,Zhong博士说:我们发现的是,相对于其疾病所带来的挑战,AD的药物开发和疗法开发的投资相对较低。(生物谷Bioon.com)

Alzheimer's Disease Drug Development Pipeline: Few Candidates, Frequent Failures

Jeffrey L Cummings*, Travis Morstorf and Kate Zhong

Introduction
Alzheimer’s disease (AD) is increasing in frequency as the global population ages. Five drugs are approved for treatment of AD, including four cholinesterase inhibitors and an N-methyl-D-aspartate (NMDA)-receptor antagonist. We have an urgent need to find new therapies for AD.

Methods
We examined Clinicaltrials.gov, a public website that records ongoing clinical trials. We examined the decade of 2002 to 2012, to better understand AD-drug development. We reviewed trials by sponsor, sites, drug mechanism of action, duration, number of patients required, and rate of success in terms of advancement from one phase to the next. We also reviewed the current AD therapy pipeline.

Results
During the 2002 to 2012 observation period, 413 AD trials were performed: 124 Phase 1 trials, 206 Phase 2 trials, and 83 Phase 3 trials. Seventy-eight percent were sponsored by pharmaceutical companies. The United States of America (U.S.) remains the single world region with the greatest number of trials; cumulatively, more non-U.S. than U.S. trials are performed. The largest number of registered trials addressed symptomatic agents aimed at improving cognition (36.6%), followed by trials of disease-modifying small molecules (35.1%) and trials of disease-modifying immunotherapies (18%). The mean length of trials increases from Phase 2 to Phase 3, and the number of participants in trials increases between Phase 2 and Phase 3. Trials of disease-modifying agents are larger and longer than those for symptomatic agents. A very high attrition rate was found, with an overall success rate during the 2002 to 2012 period of 0.4% (99.6% failure).

Conclusions
The Clinicaltrials.gov database demonstrates that relatively few clinical trials are undertaken for AD therapeutics, considering the magnitude of the problem. The success rate for advancing from one phase to another is low, and the number of compounds progressing to regulatory review is among the lowest found in any therapeutic area. The AD drug-development ecosystem requires support.

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