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抗抑郁新药“优欣定胶囊”临床试验获重大进展

来源:生物谷 2014-09-29 16:20

优欣定胶囊是我国精神类领域中第一个源于中药的1类单体化合物新药,由上海中药创新研究中心独立研制,拥有包括工艺和应用专利在内的自主知识产权,其专利范围涵盖中国、美国、德国、法国、英国、意大利、瑞典、日本、韩国等国。该新药获得了国家“十一五”及“十二五”新药创制重大专项的支持。优欣定的研制起源于传统中药人参的临床抗抑郁作用,从口服人参后的肠道代谢物中得到该化合物结构。优欣定是以人参类植物为原料经过半合成方法获得的高纯度单一化合物。大量的临床前试验证明,优欣定具有高度的抗抑郁活性且与现有的抗抑郁药物不同的作用机理。优欣定通过激活神经细胞的AKT激酶系统而达到神经细胞保护并有促进神经发生(neurogenesis)的作用。该作用机理与对抑郁症发病机制的最新研究甚为吻合。

优欣定胶囊完成的I期临床试验,证明了该药物秉承人参类中药极低毒副作用的特点。最近,作为剂量探索的多中心随机双盲安慰剂对照的IIa期临床试验,在上海精神卫生中心主持、北大六院等参与下已顺利结束。揭盲结果表明,优欣定胶囊在主要剂量范围内显示出良好的量效关系,且中、高剂量组疗效表现出优于安慰剂组的趋势。同时,优欣定各剂量组(含最高剂量组)均未见与药物相关的严重不良事件,其他不良事件发生率低且程度轻微。

国内外临床试验专家和多个国际大型制药企业精神药物领域的专家都认为,优欣定IIa期临床试验显示出的量效关系表明,中高剂量组已进入有效剂量范围并再次确认了该药物优良的安全性。因此,本次试验达到了预期的目的。与此同时,优欣定凸显的良好的临床安全性,为其下一步临床研究提供了重要的基础和依据。

一旦优欣定的开发获得成功,则新的“重磅炸弹”将随之诞生,并有可能使抑郁症患者摆脱现有临床抗抑郁药物毒副作用的困扰,进入抑郁症安全治疗的新时代。

抑郁症是一种常见的精神疾病。随着社会经济的日益发展和竞争压力的不断加剧,抑郁症状的发生率和抑郁症患病率将会越来越高,特别是城市人群中上升明显,抑郁症正成为一个严重的全球性问题。根据世界卫生组织发表的《世界卫生报告》指出,抑郁症已成为全球第四大疾患,到2020年将成为仅次于心血管病的第二大疾病。在西方工业发达国家终身抑郁症的发病率为6%-8%,随着人口的老龄化,抑郁症在60岁以上人群中的发病率高达20%-50%。目前我国的抑郁症发病率为4.6%,与世界水平相当。同时,抑郁症病人经常长时间患器质性疾病,缺勤率比常人高2-3倍,对国民经济具有重大的影响。严重抑郁症患者常有自杀意念,是造成自杀自残的主要原因。我国现有3600万人抑郁症患者,每年造成的直接和间接经济负担高达80亿美元。据广州标点医药信息机构提供的资料显示,中国抑郁症患者接受合理治疗的比例已从十年前的10%、前几年的25%上升到2010年的40%。

抑郁症的高发病率和抗抑郁药的大量需求,使得抗抑郁药物开发日益成为医疗、制药、科研等各方面关注的热点, 同时也酝酿着无限的商机。根据IMS(国际权威药品销售统计机构)调查结果显示, 2007年抗抑郁症药全球销售额高达197亿美元, 占全球药品销售额3%。而全球每年用于治疗抑郁症的医药费用高达600亿美元。

当前市场上的抗抑郁药物为少数几个西药所垄断,其作用机理均为单胺类神经递质重摄取的抑制剂。这些药物都具有各种副作用,最常见的是体重增加,胃肠道不适,性功能减退,甚至在青少年人群中有增加自杀率的倾向。由于单胺类神经递质重摄取抑制剂在2010年所有的专利均已过期,而且近年来抑郁症发病机制方面的研究表明,抑郁症病人脑内的单胺类递质水平低下并非是发病的真正原因。因此市场急需具有新抗抑郁机制的药物来填补空白。(生物谷Bioon.com)

英文原文:

Breaking News!

SIRC has concluded Phase IIa Clinical Trial of Yuxintine Capsule (S111), a novel antidepressant

Yuxintine capsule, developed by Shanghai Innovative Research Center of TCM(SIRC), has just completed its phase IIa double-blinded, randomized and placebo-controlled multi-centre clinical trial for anti-depression. Yuxintine is (code name S111) a purified compound, one of the active metabolites of ginseng, which has been used clinically for anti-depression and mood adjustment for thousands of years in China and other Asian countries.

S111 preclinical studies have shown strong anti-depression activity in all animal models that was equal or more potent than fluoxetine, used to be a blockbuster of anti-depressant that was sold 2.5 billion USD world-wide in 2010. One of those studies has published in Progress in Neuro-Psychopharmacology & Biological Psychiatry in 2010 (http://www.ncbi.nlm.nih.gov/pubmed/20647027). Recent studies further indicated that the mechanism of action (MOA) of S111's anti-depression effect is very different from any current antidepressants. The novel MOA renders Yuxintine a drug of new in class. Phase I clinical trial has demonstrated an excellent safety profile of Yuxintine, which was consistent with its toxicological dossier in animals.

Yuxintine phase IIa clinical trial was conducted in 7 GCP clinical centres across China, led by Dr.Huafang Li, a well-known clinical scientist at Shanghai Mental Health Center. In a recent conference, Principle investigators participated in Yuxintine study reviewed results of the phase IIa trial and concluded that Yuxintine capsule demonstrates a good dose-response within the major dose range and high dose groups showed better response than the placebo group. Meanwhile, no serious drug-related adverse events were reported in any groups including the highest dose group. Other mild adverse events were also rare. The clinical experts further agreed that the results of Yuxintine phase IIa suggests that the highest dose may have entered effective dose range. Given the extraordinary clinical safety of Yuxintine capsule, higher dose may be tested in phase IIb.

The incidence of mental disorders in China showed an upward trend year by year. With changes in concept of public health in China, the size of China's anti-depressant drug market enjoyed a rapid growth in the past five years. Introduction of new medical insurance directory in 2009 will further catalyze the rapid growth of the market in the future. Yuxintine capsule is a "new-in-kind" anti-depression medicine with novel MOA; it is combined with advantages of both TCM and western medicine that not only has the characteristics of high safety, fewer side effects and lower cost, but also has the advantages of well-defined chemical entity and significant benefits.

 

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