新功能、新界面、新体验,扫描即可下载生物谷APP!
首页 » 制药 » AD新希望:百健艾迪单抗BIIB037改善认知

AD新希望:百健艾迪单抗BIIB037改善认知

来源:生物谷 2014-12-04 19:01

2014年12月4日讯 /生物谷BIOON/ --导读:阿尔茨海默氏症(AD)一直是新药研发的重灾区,尽管风险极高,但尚无证据表明生物医药行业将要放弃该领域。近日,阿斯利康和礼来宣布启动阿尔茨海默氏症(AD)一项临床试验。而百健艾迪(Biogen Idec)单抗药物BIIB037在Ib期临床也传来佳讯,该药减少了患者大脑中β淀粉样斑块,并对认知具有积极的影响。百健艾迪已计划跳过II期,直接将BIIB037推进至III期临床,消息发布后该公司股价飙升8%。(相关阅读:5亿美元投成功几率仅9%AD药物——向礼来致敬阿斯利康&礼来:阿兹海默症药物进入临床试验

BIIB037是一种靶向β淀粉样蛋白(Aβ)的单克隆抗体。在该项Ib期临床试验中,经过54周治疗后,与安慰剂相比,BIIB037减少了患者大脑Aβ斑块,并表现出改善认知的积极影响。百健艾迪指出,该Ib期研究是一项早期研究,主要目的是评估BIIB037的安全性,Aβ斑块减少及认知改善是次要终点。

阿尔茨海默氏症(AD)一直是新药研发的重灾区,据统计,该领域临床失败率高达99.6%。许多曾经极具潜力的药物最终都失败了,包括辉瑞(Pfizer)和强生(JNJ)的单抗bapineuzumab及礼来(Eli Lilly)的单抗solanezumab,这2种单抗投资均超过10亿美元,在早期临床表现出极大的潜力,但在III期临床均惨遭失败。而同样的命运很可能降临在百健艾迪的BIIB037身上。

目前,市面上仅有5种药物获批用于阿尔茨海默氏症的对症症状,尚无一种药物能够逆转疾病进程,这也造就了巨大的医疗需求以及新药的重磅销售潜力。尽管新药研发路途艰难,但尚无迹象表明,生物医药行业将要放弃阿尔茨海默氏症领域的新药研发。

根据世界卫生组织(WHO),在全球范围内阿尔茨海默氏症(AD)患者总数高达3500万例,这一数字预计将每20年翻一番,在2030年达到6600万例。在美国,患者总数超过500万例。

百健艾迪的AD管线:

今年3月,百健艾迪与日本药企卫材(Eisai)达成合作,共同开发卫材管线中2种AD药物(BACE抑制剂E2609和单抗BAN2401)和百健艾迪管线中2种AD药物(单抗BIIB037和一种抗tau单抗)。E2609是新一代口服BACE抑制剂,通过抑制BACE能够减少大脑中的Aβ蛋白,具有改善症状和延缓疾病进展的潜力。BAN2401是一种抗Aβ单抗,能够选择性结合、中和并消除可溶性和有毒性Aβ的聚集,具有免疫调节作用并有望阻止病情恶化。BIIB037也是一种抗Aβ单抗,能结合并消除AD患者大脑中的毒性Aβ斑块,具有阻止病情恶化的潜力。(生物谷Bioon.com)

英文原文:Biogen barrels toward Alzheimer's Phase III after a promising early signal

Biogen Idec ($BIIB) is heralding hope in one of the industry's toughest fields, plotting a late-stage trial for an Alzheimer's disease treatment after charting some surprising positive results in an early study

The treatment, BIIB037, is an antibody targeting beta amyloid proteins, which build up in the brain and, it is widely believed, contribute to Alzheimer's neurodegenerative effects. In a Phase Ib study designed to measure the drug's safety, Biogen noted a dose- and time-dependent reduction in amyloid levels at 52 weeks, R&D chief Doug Williams said at the Deutsche Bank BioFEST conference, and BIIB037 also had a positive effect on patients' cognition.

Now Biogen is "planning very aggressively" to get the antibody into Phase III, Williams said, as quoted by CNBC, a pronouncement that sent the Big Biotech's shares up nearly 8% on Tuesday morning. The company hasn't disclosed a particular timeline for its late-stage program.

Biogen hopes BIIB037 can succeed where so many once-promising programs have failed. Many Alzheimer's treatments--including Eli Lilly's ($LLY) solanezumab and Pfizer ($PFE) and Johnson & Johnson's ($JNJ) bapineuzumab--have demonstrated great potential in early trials only to fail miserably in Phase III, contributing to a daunting 99.6% clinical trial failure rate for such drugs, according to Cleveland Clinic's Jeffrey Cummings.

And the same fate could well befall Biogen's drug, but the rampant spread of Alzheimer's and potential windfall in store for a successful treatment are enough to make any measurable clinical activity a big deal to investors and investigators.

BIIB037 is one facet of Biogen's all-hands approach to Alzheimer's. Alongside partner Eisai, the company is working on a treatment that targets beta secretase, which key to the production of amyloid, and one that homes in on the tau protein, also found in Alzheimer's sufferers. Per a deal signed in March, Eisai has the option of jointly developing BIIB037 under undisclosed terms.

温馨提示:87%用户都在生物谷APP上阅读,扫描立刻下载! 天天精彩!


相关标签

最新会议 培训班 期刊库