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阿斯利康呼吸类药物benralizumab治疗哮喘研究取得进展

来源:生物谷 2014-10-10 13:51

2014年10月10日讯 /生物谷BIOON/ --阿斯利康公司在今年可谓度过了艰难的一年,公司首先是由于辉瑞公司的收购案而被卷入了风暴中心,公司为了摆脱其收购而使劲浑身解数。

尽管英国政府和民间的强烈反对使得阿斯利康避免了被收购的命运,但在研发过程中,阿斯利康却频频受挫。就在一天前公司正式宣布与合作长达九年之久的Targacept公司正式分道扬镳,这也宣告了双方在阿尔兹海默症和抑郁症领域的药物研发工作正式结束。(相关阅读:苦求9载无果,阿斯利康最终终止与Targacept合作

不过,最近开发的关于呼吸类药物benralizumab治疗哮喘的研究却让其多少有了一些安慰。虽然这种药物在治疗慢性阻塞性肺炎(COPD)的中期研究中表现不佳,但在治疗哮喘症的研究中却展现出一丝曙光。根据公司最新完成的研究数据显示,benralizumab能够使哮喘症患者体内的嗜酸性粒细胞数量显着下降,而这一指标与哮喘和COPD的发生有着直接关系。目前研究人员认为这一药物能够显着降低哮喘的发作。然而研究数据中也折射出一些不容乐观的地方,例如低剂量的benralizumab不仅无法改善哮喘症患者的病情,反而可能增加嗜酸性粒细胞的数目。

显然,阿斯利康公司将这一信息作为公司研发的一个强心剂,并希望趁热打铁,将研究进一步深入下去。事实上一些分析人士也对这种药物表现出很强信心,他们估计benralizumab一旦上市,其年销售额最大可能达到20亿美元左右。不过,众所周知,药物的研发从来不是唯产品论,在哮喘症这一市场中已经充斥了葛兰素史克、梯瓦和诺华等强有力的竞争者。可以预见,即使benralizumab如阿斯利康的预期进入市场,也必将遭到上述公司产品的狙击。(生物谷Bioon.com)

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详细英文报道:

It's one step back, one step forward for AstraZeneca's key respiratory drugbenralizumab. After acknowledging a midstage setback for the drug in COPD last month, AstraZeneca's big MedImmune division has come back with positive, though somewhat mixed, Phase IIb data underscoring the effectiveness of knocking down eosinophils--white blood cells--in preventing asthma attacks.

Benralizumab--an IL-5 antibody--reduced the rate of asthma exacerbations, hitting the primary endpoint in the trial, says AstraZeneca ($AZN). But the study flagged weak results for the low end of the doses used in the trial, with the top dose doing better in patient groups which could

be identified with higher levels of eosinophils, which are widely considered a trigger for asthma as well as COPD. In its statement, MedImmune noted a treatment response ranging from 40% to 70%, depending on the dose and subpopulation treated.

AstraZeneca is using the results to help guide the late-stage studies now underway. The pharma giant pushed ahead with a Phase III trial of benralizumab in COPD, jumping off ahead of a Phase IIa failure. In that study with 101 patients, benralizumab failed to improve the rate of acute exacerbations. And there was also a higher rate of severe treatment-emergent adverse events in the drug arm.

Eosinophils, though, may point to a future for this drug in asthma and COPD, which spurred AstraZeneca to assign a peak potential sales figure of $2 billion to the therapy as it wrestled out of Pfizer's ($PFE) embrace earlier this year. The current data was published in The Lancet.

But it's a crowded field in which GlaxoSmithKline ($GSK), Teva ($TEVA) and Novartis ($NVS) play a big role. GlaxoSmithKline started a Phase III study for mepolizumab in COPD patients last April as it wrapped a successful late-stage effort in asthma. And Teva's reslizumab also did well in Phase III for asthma.

"Asthma is a highly heterogeneous disease and these data advance our understanding of patient subtypes, potential biomarkers and targeted therapies to achieve the best outcomes for patients," said Bing Yao, the head of MedImmune's Respiratory, Inflammation and Autoimmunity Innovative Medicines Unit. "The insights from this Phase II trial played a key role in the design of our Phase III asthma programme. We are encouraged by the development prospects for benralizumab as a potential innovative medicine for patients with severe asthma and COPD."

 

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