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一箭双雕 百健MS新药被证明能够修复受损神经元

来源:生物谷 2015-04-16 16:18

2015年4月16日讯 /生物谷BIOON/ --医药公司总是希望自己开发的新药能够有尽可能多的适应症,因此许多药物在研发过程中都会开展多种临床适应症的相关研究。不过,由于缺乏相关的前期研究,许多此类临床研究都会以失败告终。不过,最近Biogen公司却收获了一个意外的惊喜。

Biogen公司最近宣布,研究人员在一项临床二期实验中发现,公司开发的治疗多发性硬化症药物anti-LINGO-1在修复神经组织损伤方面具有意想不到的疗效。

研究人员此前招募了82名志愿者,研究这种药物对于急性视神经炎(AON)的治疗效果。结果显示,在患者接受药物治疗的第24周,五个不同剂量治疗组患者视神经信号传导速度提升了34%左右,第32周时这一数字达到了41%,与对照组有显着性差异,达到了实验设计的首要预期终点。这表明anti-LINGO-1可能在治疗神经组织受损方面有着意想不到的效果。

不过,也有分析人士指出此次临床研究未能证明这种药物能够增加髓鞘--神经元外周的蛋白层--厚度并改善患者视觉功能。但是,Biogen公司回应称这是由于此次参与临床实验的一些患者之间视觉神经髓鞘厚度差异已经很存在显着性差异,anti-LINGO-1才未能在这一方面证明自己的能力。

不过,不论结果如何,这也预示着anti-LINGO-1将可能增添一种新的适应症,或许令其在未来给Biogen带来更多收益。不过,Biogen公司也并未忘记anti-LINGO-1原本的使命,研究人员正在紧张的进行这种药物治疗多发性硬化症的临床二期研究,据悉整个实验周期长达84周,预计Biogen公司将于2016年获得这种药物治疗多发性硬化症疗效的相关数据。Biogen公司是否能双喜临门还需要用数据来说话。(生物谷Bioon.com)

详细英文报道:

Biogen's ($BIIB) latest treatment for multiple sclerosis helped repair damaged nerve tissue in a Phase II study, an incremental victory for a novel therapy that has a long way to go.

The treatment, anti-LINGO-1, met its main goal in a study on 82 patients with acute optic neuritis (AON), a disease in which inflammation erodes the layers of protein that protect nerve fibers. Biogen designed the study to measure nerve function by clocking how fast a signal moved from the retina to the brain, with a primary endpoint of improving reaction times compared with placebo. In the study, patients who got at least 5 doses of the antibody demonstrated a 34% improvement on that measure compared at week 24. At 32 weeks, that number jumped to 41%, Biogen said, and both results were statistically significant.

However, anti-LINGO-1 had no effect on the actual thickness of the protein layers, called myelins, and it didn't help improve patients' visual function in the study. Looking at imaging results, Biogen notes that some of the myelins in question had significantly thinned before treatment, meaning the antibody may not have had the chance to prove itself on that measure. And the study's investigators are heralding the results as the first ever demonstration of myelin repair by any metric.

AON has no causal relationship with MS, but both diseases are characterized by the slow destruction of healthy nerve tissue, and Biogen figures any positive results in the former indication have a strong read-through for the latter. Despite the miss on secondary endpoints, the company is counting its Phase II effort, called RENEW, as a net positive for anti-LINGO-1.

"RENEW studied two distinct mechanisms of action--remyelination and neuroprotection," Biogen Chief Medical Officer Alfred Sandrock said in a statement. "We believe that the opportunity to impact neuroprotection was limited by the rapidity with which retinal ganglion cells and their nerve fibers were damaged by the disease. This insight offers valuable information on the speed of axonal loss following an AON attack, and combined with the positive primary endpoint results, will help inform future studies."

Biogen is at work on a separate Phase II trial, called SYNERGY, that is studying the antibody's ability to slow the progression of MS, measuring composite change in cognitive function over 84 weeks. Data from that study are expected in 2016 and will likely make or break the treatment's potential.

 

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