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百健艾迪髓鞘再生新药临床二期研究喜忧参半

来源:生物谷 2015-01-11 16:05

2015年1月11日讯 /生物谷BIOON/ --著名制药公司百健艾迪最近公布了其用于髓鞘再生药物anti-LINGO-1的一系列临床二期研究数据,这种药物能够治疗多发性硬化症等一系列疾病引起的神经元损伤。

虽然公司对此次研究数据做出了高度的评价,但是仔细审视此次的临床二期数据,分析人士仍然敏锐的注意到这其中的隐忧。在此次公布的临床二期研究数据中,研究人员利用anti-LINGO-1治疗急性视神经炎,研究结果虽然达到了首要预期终点--改善了视觉信号从视网膜传递到视觉皮层的时间,改善率达到了34%。但是却未能达到其第二终点,既改善视网膜层厚度。

同时,分析人士还注意到,如果将意向治疗组(ITT)考虑进入退出治疗的患者群体,那么anti-LINGO-1甚至未能达到其首要预期终点。而ITT,众所周知,是这一研究领域中的金标准。这一忧虑也直接体现在公司的股价上,当公司刚宣布这一研究结果时,公司股价应声上扬,随着对数据分析的深入,投资者的热情出现迅速减退。

百健艾迪公司一直认为,修复髓鞘损伤是治疗如多发性硬化症等疾病造成的神经元损伤的重要步骤。而急性视神经炎也是公司选用的证明其猜想的重要环节之一。而公司目前正在进行的另一项临床二期研究则是探索anti-LINGO-1治疗多发性硬化症所造成的损伤。

作为多年活跃在生物医药产业的生物医药公司,近年来百健艾迪公司在研发领域取得一系列研发成果,使其跻身一线生物医药企业之列。(生物谷Bioon.com)

详细英文报道:

Biogen Idec ($BIIB) highlighted positive data from its mid-stage study of anti-LINGO-1, a closely watched drug that raises the potential for spurring remyelination--repairing the damage done by diseases like multiple sclerosis. But a careful second look at the results also underscores just how challenging this development program is for Biogen Idec, raising doubts about the true clinical significance of the results that quickly eliminated a spike in the company's share price.

This first of two Phase II studies in the program was for acute optic neuritis. Investigators for Biogen Idec said that their drug hit the primary goal: improving the time it takes for a signal to shoot from the retina to the visual cortex.

But the drug also failed some key hurdles in the study, including its secondary endpoints, which involved a look at the change in thickness of the retinal layers, or optic nerve neurons and axons. In addition, investigators noted that if you included what's called the intent-to-treat (ITT) group, adding back in the patients who dropped out of the small study, anti-LINGO-1 did not hit the primary endpoint. ITT is the gold standard in this field, and quite a few analysts were quick to pick up on the implications.

"BIIB announced top line data for the RENEW trial of the anti-LINGO MAb BIIB033 that the company called 'positive' and which we can't absolutely disagree with, but we think could be considered equivocal by many," noted Leerink's Joseph Schwartz.

Shares of Biogen spiked early as investors reacted to the news, but quickly settled back and then slipped into the red this morning.

Acute optic neuritis--or AON--was the first of two mid-stage challenges that Biogen Idec set up for itself as the company probed for solid human data to either back up or disprove the notion that this therapy could repair the harm done by demyelination--damage done to the myelin sheath of axons needed to guard neurons. Myelin is essential to the proper function of the central nervous system and a big focus at Biogen Idec, which has specialized in multiple sclerosis for years.

In this study the investigators tracked a 34% improvement in the recovery of optic nerve latency among the patients who finished the study (per protocol). The next big step will come when Biogen Idec's Phase II study for MS reads out in 2016. And despite the troubling missteps in the first Phase II, Biogen Idec believes it has plenty to be encouraged about as they ponder a pivotal program.

"We believe the RENEW results are encouraging, as this is the first clinical trial to provide evidence of biological repair in the central nervous system (CNS) by facilitating remyelination following an acute inflammatory injury," said Dr. Alfred Sandrock, group senior vice president and chief medical officer at Biogen Idec. "We look forward to the SYNERGY results in 2016 to further advance our understanding of this molecule in MS, including a full dose response. The totality of the data from the two Phase II studies may provide us with a clearer understanding of anti-LINGO-1's clinical potential."

Biogen Idec has scored a series of successes in the clinic in recent years, standing out as one of the most successful businesses in the industry. It's built much of its rep around slowing the progression of MS. This new program, though, would be a step toward reversing demyelination diseases, which would be a radical step forward.

 

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