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百特公司新型血友病药物BAX817临床三期研究取得理想结果

来源:生物谷 2015-03-15 14:24

2015年3月15日讯 /生物谷BIOON/--著名制药公司百特医疗最近宣布公司开发的治疗血友病药物BAX817的临床三期研究获得了圆满成功。这也为公司上市BAX817,进一步巩固公司在血友病治疗市场中的地位扫清了又一个障碍。

根据公司最新公布的临床研究数据显示,使用了BAX817治疗的患者在发生急性出血后12小时的总体成功率达到了92%左右,而89%的患者在接受BAX817治疗24小时后仍体现出了治疗效果。这一结果也达到了研究人员设计此次临床三期研究的首要终点。另一方面,研究人员同时还表示这种药物的安全性也令人满意。在整个临床研究中没有患者因为药物副作用而退出研究。

众所周知,血友病是因为体内凝血机制出现障碍而导致患者在出血后无法及时使血液凝固。而严重时,这种疾病会导致患者出现死亡。目前市场上的许多治疗血友病药物都是凝血因子疗法,这种药物的一个弊端在于人体的免疫系统会逐渐对这种药物产生抗性,并最终中和药物,使其失去疗效。BAX817的研发就是为了解决这一重要问题,此次临床研究中的志愿者全部都产生了相应的药物拮抗物。从这点出发,BAX817的疗效也是相当显着。

近段时间,百特医疗传出将一分为二的计划。百特医疗公司计划将旗下的生命科学部门剥离并成立一家名为Baxalta的新公司。(相关报道:百特2亿2千万美元收购自身免疫药物公司SuppreMol)公司计划通过这次分离实现自身资源的优化重组。(生物谷Bioon.com)

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详细英文报道:

Baxter ($BAX), on the eve of biotech spinout, declared Phase III victory for a hemophilia treatment designed to help patients not responding to standard therapy.

The drug, BAX 817, is designed to replace the missing blood factors that stop blood from clotting normally and cause hemophilia. Many hemophilia patients come to develop inhibitors of such factor-replacement therapies, and Baxter's latest treatment is designed with them in mind.

In an open-label Phase III study on hemophilia A or B patients with inhibitors, BAX 817 met its primary endpoint of treating acute bleeding episodes after 12 hours of administration, the company said. The injected drug notched an overall success rate of 92% after 12 hours, according to Baxter, and 89% of patients reported sustained bleeding control after 24 hours. And, importantly, the drug didn't spur the development of any new inhibitors or binding antibodies, Baxter said.

The company is saving full results for a medical meeting later this year, disclosing that no patients dropped out due to adverse events but that one was hospitalized after a major bleed.

Now Baxter is preparing for global regulatory filings for BAX 817, aiming to extend its wide range of hemophilia products with an eye on patients with inhibitors.

"The development of inhibitors remains one of the most significant challenges in treating hemophilia, as it may place patients at increased risk for life-threatening complications resulting from difficult-to-treat bleeding episodes," John Orloff, head of R&D at Baxter BioScience, said in a statement.

Baxter is months away from a long-planned split in two, in which its biopharma division will strike out on its own as the publicly traded Baxalta and leave med tech and dialysis services to its counterpart. In preparation, the soon-to-be Baxalta has signed a slew of deals to expand its pipeline beyond its home base of hemophilia, most recently buying autoimmune biotech SuppreMol for $225 million and signing a $970 million oncology deal with Merrimack ($MACK).

 

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