Neurocrine Biosciences生物公司在去年由于其研发的用于治疗罕见的运动机能紊乱疾病的50mg剂量药物二期研究未能达到预定目标而宣告失败使公司股价一度遭受重挫。然而现在公司研发的治疗迟发性运动障碍新药NBI-98854二期研究传出了积极的结果,根据公司数据透露,此次二期研究的药物剂量约为75mg,其效果相比去年的50mg剂量明显许多。这一结果也促使公司股价飙升60%之多。NBI-98854是一种小分子VMAT2抑制剂,此次二期研究反映出其药效和安全性都值得肯定。公司计划在进行三期研究前将药物提交到FDA进行预审核。直到现在,市面上并没有一种特效药治疗迟发性运动障碍,这也使得市场对NBI-98854的期望相当之大。
详细英文报道:
Back in September, shares of Neurocrine Biosciences ($NBIX) were subjected to a beating at the hands of investors unhappy with the news that the 50-mg dose of its experimental therapy for a rare movement disorder failed the primary endpoint in a Phase IIb study--even though the 100-mg dose performed as hoped. Last night, the biotech experienced a dramatic improvement in its fortunes as a 75-mg dose delivered the goods in a follow-up Phase IIb trial.
Shares of Neurocrine ($NBIX) shot up 60% on the successful study of NBI-98854, a small-molecule VMAT2 inhibitor designed to treat tardive dyskinesia. And with the mid-stage program wrapped on a positive note, the company says it's ready to ask the FDA for a meeting in advance of a pivotal, late-stage trial.
"The profound response in this Kinect 2 study demonstrates the potential of NBI-98854 as both a safe and highly effective treatment for patients suffering from tardive dyskinesia," said Christopher O'Brien, the chief medical officer of Neurocrine Biosciences, in a statement. "It is clear from these results that the use of blinded central AIMS raters coupled with the ability to titrate up to 75 mg of NBI-98854 were both critical to the success of this trial."
There are no therapies for this disease, which had helped spur some enthusiasm for the drug among some analysts.
Neurocrine's lead program is for elagolix, an endometriosis therapy that won a $575 million deal back in 2010 with Abbott ($ABT), which later spun off its drug business as AbbVie ($ABBV). That's still the primary focus of the company and analysts. A Phase III study for that drug was launched in 2012, and the partners say they can file for an approval in 2016, provided the data are right.
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